Radiopharmaceutical dose calculation method and apparatus for pre-injection analysis for imaging

Abstract

The present invention relates to a radiopharmaceutical dose calculation method and apparatus for pre-injection analysis for imaging. The calculation method comprises: acquiring the current radioactivity of a radiopharmaceutical and a weight and a height of the currently medicated patient; generating a first standard curve on the basis of data in a data lookup table; generating a second standard curve on the basis of a total activity dose formula; and plotting the first standard curve and the second standard curve into a same coordinate system to form two standard curves whose envelopes define a safe medication range and which do not completely overlap, and determining, on the basis of the standard curves, a desired volume of the radiopharmaceutical to be withdrawn for the current injection for the patient. The calculation apparatus can execute the calculation method. The present invention not only improves accuracy of radiopharmaceutical dose calculation, but also significantly improves system operating efficiency and user experience. By means of accurate activity measurement and accurate patient information entry, the system can quickly generate a personalized dose scheme, thereby reducing errors caused by manual operation and improving use safety and effectiveness.

Description

Method and apparatus for calculating radiopharmaceutical dosage for imaging pre-injection analysis Technical Field

[0001] This invention relates to the field of radiopharmaceutical calculation technology, and in particular to a method and apparatus for calculating the dosage of radiopharmaceuticals for pre-injection imaging analysis. Background Technology

[0002] Radiopharmaceuticals are a class of drugs containing radioactive isotopes, widely used in medical diagnosis and treatment. The radioactive isotopes in radiopharmaceuticals decay over time, gradually decreasing in activity. The half-lives of different radioactive isotopes vary considerably. Therefore, the rate of change in the activity of radiopharmaceuticals over time differs, posing different requirements for their use and management.

[0003] CN116486991A discloses a method for controlling the activity of a radionuclide, primarily for use in radiotherapy. Its core principle lies in dynamically adjusting the injection rate and time by measuring the actual activity of the radionuclide and comparing it with a predetermined activity, combined with real-time monitoring of the patient's vital signs and radionuclide distribution during injection. However, this method has the following significant technical limitations, failing to meet the specific requirements for radiopharmaceutical dosage calculation in imaging diagnostics (such as PET-CT):

[0004] First, the existing dosage calculation method relies entirely on the patient's basic physiological parameters such as weight, age, and gender, as well as the matching results of historical treatment protocols, without considering personalized parameters directly related to radiopharmaceutical metabolism and accumulation (such as blood glucose levels, insulin sensitivity index, liver enzyme activity, and renal clearance). This singular calculation method ignores the impact of individual patient differences on drug metabolism rates and distribution characteristics, resulting in a lack of accuracy in dosage calculations and making it difficult to meet the dual constraints of dosage safety and imaging clarity in imaging scenarios.

[0005] Secondly, the dosage control process of this existing technology relies on real-time monitoring and subjective adjustments by the physician during injection, a model that is completely impractical in imaging scenarios. Imaging drugs (such as 18F-FDG) have extremely short half-lives (approximately 110 minutes), requiring precise dosage calculation before injection and immediate imaging after injection, leaving no room for dynamic adjustments during injection or supplemental dosage operations after injection. This existing technology has not designed a corresponding dosage calculation model for such time-sensitive requirements, and its method can lead to the accumulation of dosage errors in imaging scenarios, thereby causing image quality degradation or the risk of excessive radiation.

[0006] Furthermore, this existing technology does not incorporate a dual-track mechanism combining data lookup tables and numerical calculations, nor does it construct a safe dosing range based on the envelope of a standard curve of body surface area (BSA) and total activity dose (D). This dose calculation method, lacking quantitative calibration and safety threshold constraints, may lead to dose deviations from the reasonable range in imaging scenarios due to individual differences or fluctuations in drug properties (such as activity decay rate), failing to guarantee imaging effectiveness and patient safety.

[0007] Finally, the prior art does not disclose any technical features regarding hardware configuration and automated dose calculation. Its method is highly dependent on manual operation, resulting in large measurement errors, cumbersome operation, and low efficiency, making it difficult to meet the needs of rapid, efficient, and accurate use of radiopharmaceuticals in imaging scenarios.

[0008] The aforementioned technical deficiencies prevent the existing radionuclide activity control method from being directly applied to the field of imaging diagnostics, especially in scenarios such as PET-CT where dose accuracy and operational timeliness are extremely important, presenting a fundamental contradiction. Summary of the Invention

[0009] This invention discloses a method for calculating the dosage of radiopharmaceuticals for pre-injection imaging analysis, comprising the following steps:

[0010] Obtain the current radioactivity of the drug in the storage bottle and the weight and height of the patient currently receiving the drug;

[0011] The first standard curve is generated based on data from a built-in data lookup table of different types of radiopharmaceuticals, which is based on experience and summarized from the data.

[0012] A second standard curve is generated based on a total activity dose formula that uses a pre-defined standard recommended dose as a coefficient for a specific drug type and treatment purpose.

[0013] The first and second standard curves are placed in the same coordinate system to form two non-overlapping standard curves that form the safe range for drug administration. The volume of drug required for the current injection of the patient is determined based on the standard curves. Both the first and second standard curves use body surface area as the abscissa and total activity dose as the ordinate.

[0014] The recommended dose or total activity dose is adjusted based on the type of drug and in conjunction with the patient’s individual circumstances, which are physiological parameters related to the patient’s metabolism and accumulation of the radiopharmaceutical, including blood glucose levels, insulin sensitivity index, liver enzyme activity and / or renal clearance.

[0015] The method for calculating radiopharmaceutical dosage for pre-injection analysis in this invention has significant innovation and unexpected beneficial effects compared to existing technologies (such as CN116486991A). Firstly, this invention designs a safety zone model with a dual standard curve envelope to address the dual constraints on radiopharmaceutical dosage (i.e., the upper limit of radiation safety and the lower limit of image clarity) in imaging scenarios (such as PET-CT). By combining a first standard curve generated from empirical data with a second standard curve based on a recommended dosage formula, it ensures that the dosage meets both radiation protection requirements (ALARA principle) and image quality requirements (such as SUV value compliance). This safety zone model solves the dosage deviation problem caused by relying solely on historical experience matching or single-parameter calculation in CN116486991A. It is particularly suitable for scenarios where imaging drugs (such as 18F-FDG) must be precisely calculated in a single injection due to their short half-life (approximately 110 minutes), avoiding the technical defects of not being able to dynamically adjust the dosage or perform supplementary injections after injection. Secondly, this invention introduces a patient-specific parameter correction mechanism, comprehensively considering physiological parameters directly related to drug metabolism and accumulation, such as blood glucose levels, insulin sensitivity index, liver enzyme activity, and renal clearance rate, to dynamically adjust the recommended dose or total activity dose. For example, hyperglycemic patients need an increased dose to compensate for glucose competitive inhibition of drug uptake, while patients with renal insufficiency need a reduced dose to avoid increased background noise caused by delayed drug clearance. This refined individualized adjustment cannot be achieved by the calculation method in CN116486991A, which is based solely on basic parameters such as weight and age. Furthermore, this invention, through integrated hardware and software automated calculations and the signal connection between the activity measurement unit and the analysis unit, corrects for dose loss caused by syringe adhesion in real time (predicting adhesion amount through image segmentation algorithms and neural network models), significantly reducing human error (traditional methods have a dispensing error rate >5%) and shortening operation time from 2-3 minutes to seconds, greatly improving drug dispensing efficiency and accuracy. CN116486991A does not disclose any hardware configuration or automation features, and its method of adjusting dosage based on manual experience is completely impractical in imaging scenarios. This invention, however, fills a technological gap in imaging dosage control through the synergistic effect of a hyperbolic safety range and personalized parameter correction. Finally, this invention flexibly addresses the differences in dosage requirements for different drug types (such as 18F-FDG, 99mTc, etc.) and diagnostic purposes through a dual-track mechanism of data lookup tables and numerical calculations. Simultaneously, it records all calculation process data for subsequent optimization, providing a scientific basis for clinical decision-making. These innovations not only overcome the fundamental technical contradictions of CN116486991A in imaging scenarios (such as the impracticality of dynamic adjustment, lack of personalized parameters, and large human error), but also solve industry pain points (such as high rate of duplicate examinations and insufficient radiation risk control), achieving a balance between dosage accuracy, operational timeliness, and individualized adaptability, demonstrating significant clinical value and technological advancement.

[0016] This invention also discloses a radiopharmaceutical dosage calculation device for pre-injection analysis in imaging. This device determines the required volume of drug to be extracted for the current injection of a patient based on the radioactivity of the drug in the storage vial and relevant basic information about the patient. Upon receiving the current radioactivity and the patient's weight and height, the device generates a first standard curve based on data from a built-in, experience-based lookup table for different types of radiopharmaceuticals. It also generates a second standard curve based on a total activity dose formula with a pre-defined standard recommended dose as a coefficient for specific drug type and treatment purpose. Both the first and second standard curves use body surface area as the abscissa and total activity dose as the ordinate, thus forming two non-overlapping standard curves in the same coordinate system, with the envelope forming a safe range for drug administration.

[0017] The computing device can adjust the recommended dose or total activity dose based on the drug type and in conjunction with the patient's individual circumstances, which are physiological parameters related to the patient's metabolism and accumulation of radiopharmaceuticals, including blood glucose levels, insulin sensitivity index, liver enzyme activity, and / or renal clearance.

[0018] After receiving the current radioactivity of the drug in the storage bottle from the activity measurement unit and the relevant basic information of the current patient from the input unit, the computing device can determine the volume of drug to be injected by searching a built-in data lookup table for different types of radiopharmaceuticals based on experience, and / or determine the volume of drug to be injected by numerical calculation based on the patient's specific physiological parameters and the specific activity of the drug.

[0019] By combining data lookup tables and numerical calculations, this invention provides a flexible dosage calculation method that significantly improves the accuracy and personalization of dosage calculations. The data lookup table, based on extensive clinical experience and data accumulation, ensures the accuracy and reliability of dosage calculations; the numerical calculation method enables personalized dosage calculations based on the patient's specific physiological parameters and drug characteristics, improving dosage precision and diagnostic / therapeutic efficacy. Furthermore, this flexible dosage calculation method can adapt to different types of radiopharmaceuticals and varying diagnostic / therapeutic needs, enhancing the system's adaptability and scalability.

[0020] When the computing device determines the required volume of drug to be injected through numerical calculation, it selects patient-specific physiological parameters, including body surface area calculated based on the patient's height and weight. Based on the obtained body surface area, it calculates the total active dose that the patient should receive in combination with the recommended dose of the corresponding drug.

[0021] By calculating the patient's body surface area and combining it with the recommended drug dosage, this invention provides a more personalized dosage calculation method, significantly improving the accuracy of dosage calculation and diagnostic / therapeutic effects. Body surface area is an important physiological parameter that can more accurately reflect the patient's metabolic needs and drug distribution characteristics, thereby improving the personalization level of dosage calculation. This body surface area-based dosage calculation method not only helps to achieve more scientific and personalized diagnostic / treatment plans, but also reduces diagnostic / treatment failures caused by inaccurate dosage, improving the safety and effectiveness of use.

[0022] The computing device can receive the current radioactivity of the drug in the storage bottle through the activity measurement unit. The activity measurement unit deploys corresponding detectors at dedicated measurement points near the corresponding storage bottle in the storage area of ​​the drug bottle. The raw signals collected by the detectors are converted and sent to the processor of the activity measurement unit for signal processing to calculate the radioactivity of the drug.

[0023] By deploying detectors at dedicated measurement sites within the storage area of ​​the drug reservoir, this invention significantly improves the accuracy and stability of activity measurements. This design not only reduces interference and loss along the signal transmission path but also ensures that each sample is correctly placed in front of the detector, avoiding measurement errors caused by improper placement. The dedicated measurement sites also enable simultaneous multi-point measurements, further enhancing the consistency and reliability of the results. Furthermore, this high-precision measurement method provides more reliable data support for subsequent dose calculations, facilitating more refined and personalized diagnostic / treatment plans and improving patient outcomes and quality of life.

[0024] The processor of the activity measurement unit integrates the calibrated signal using the gradient method to obtain the total energy or total count of the signal. Then, based on the integration result and physical parameters, it calculates the radioactivity of the drug, whereby the physical parameters include detector efficiency and / or calibration factor.

[0025] By integrating the corrected signal using the gradient method and combining it with physical parameters such as detector efficiency and calibration factor, this invention significantly improves the accuracy and stability of activity calculation. The gradient method effectively eliminates noise and interference in the signal, improving the signal-to-noise ratio and ensuring high accuracy in activity measurement. The introduction of detector efficiency and calibration factor further corrects the measurement results, eliminates systematic errors, and ensures the reliability of activity calculation. This high-precision activity measurement method not only provides more reliable data support for dose calculation but also facilitates real-time monitoring and dynamic adjustment of drug activity, improving the system's intelligence level.

[0026] The data processed by the processor of the activity measurement unit can be displayed to the user through a graphical interface. The processor of the activity measurement unit can communicate with the medical staff so that the interface of the medical staff can display key parameters including the current measured activity value and the reference range, and provide historical data query function.

[0027] Through a graphical interface and communication connection with healthcare professionals, this invention not only provides intuitive data display but also enables real-time data sharing and remote management. The graphical interface allows healthcare professionals to intuitively view current activity values ​​and reference ranges, promptly understanding the drug's activity status and improving operational convenience and accuracy. Simultaneously, the historical data query function provides detailed medication records and historical data, aiding healthcare professionals in subsequent management and analysis, and optimizing diagnostic / treatment plans. Furthermore, the remote management function enables cross-regional data sharing and collaborative work, improving the utilization efficiency of medical resources, contributing to the advancement of medical informatization, and enhancing the overall level of medical services.

[0028] The device can communicate with an input unit for obtaining basic information about the patient currently taking medication, such as the patient's weight and height. The input unit can be equipped with a digital input device.

[0029] The input unit can verify the accuracy of the basic information input through the input device by setting the numerical range of the corresponding parameters, so that the correct basic information entered in the input unit can be transmitted to the computing device through a secure protocol.

[0030] By configuring digital input devices and setting parameter ranges, this invention significantly improves the accuracy and completeness of patient information entry. The digital input devices provide a user-friendly interface, reducing errors from manual input and ensuring data accuracy and consistency. The parameter range verification mechanism automatically detects and corrects errors in the input data, preventing dosage calculation errors caused by inaccurate data. Furthermore, secure protocol transmission ensures the security and integrity of data during transmission, preventing the risk of data tampering or leakage. This high-precision data entry and transmission mechanism not only improves system reliability and security but also facilitates standardized and regulated data management, promoting the development of medical informatization and enhancing the overall level of medical services.

[0031] The computing device can communicate with a volume measurement unit used to measure the current residual volume of the drug in the storage bottle. The volume measurement unit can be equipped with electrodes on the outside of the corresponding storage bottle, so that the computing device can use the residual volume of the drug obtained by the volume measurement unit based on capacitive volume measurement technology to calculate the volume of drug required by the patient.

[0032] By deploying (ring-shaped) electrodes on the outside of the drug reservoir and using capacitive volumetric measurement technology, this invention enables non-contact volumetric measurement, significantly improving measurement accuracy and stability. The ring-shaped electrode design ensures uniform distribution of the measurement signal, avoiding measurement errors caused by improper placement. This non-contact measurement method not only avoids drug contamination and radiation exposure risks for operators but also enables multi-point synchronous measurement, further improving the consistency and reliability of measurement results. Furthermore, this high-precision volumetric measurement method provides more reliable data support for dosage calculation, contributing to more refined and personalized diagnostic / treatment plans, and improving patient diagnostic / treatment outcomes and quality of life.

[0033] The computing device can communicate with the timing unit, which can start timing when the computing device obtains the calculation result. The timing unit can set different interval durations for different types and states of drugs.

[0034] If the drug measurement is not completed within the set interval, the drug measurement operation is determined to be invalid. The timing unit sends an invalid signal to the computing device so that the computing device can recalculate based on the current situation.

[0035] By monitoring the time intervals of drug dispensing in real time and setting different interval durations, this invention can significantly improve the accuracy of drug dosage and diagnostic / therapeutic effects. Setting different interval durations for different types and states of drugs better adapts to the activity variation characteristics of different drugs, improving dosage accuracy and diagnostic / therapeutic effects. When the set interval duration is exceeded, the system can promptly issue an alarm and recalculate the dosage, avoiding diagnostic / therapeutic failures due to low activity, thus improving the system's reliability and safety. Furthermore, this real-time monitoring and dynamic adjustment mechanism enables full-process tracking and management of drug activity, improving the system's intelligence level, helping to optimize medical processes, and enhancing the overall level of medical services.

[0036] The timing unit can adjust the interval between each drug in real time based on parameters including the drug's half-life, current activity value, and maximum allowable activity loss. The maximum allowable activity loss can be calculated by the computing device based on a preset maximum error value when calculating the drug volume.

[0037] By adjusting the interval between drugs in real time based on parameters such as the drug's half-life, current activity value, and allowable maximum activity loss, this invention significantly improves the accuracy of drug dosage and diagnostic / therapeutic efficacy. The introduction of half-life and current activity value makes the interval setting more scientific and reasonable, better adapting to the activity variation characteristics of different drugs. The calculation method for allowable maximum activity loss ensures the accuracy and reliability of dosage calculation, avoiding diagnostic / therapeutic failures due to excessively low activity. Furthermore, this dynamically adjusted timing mechanism enables real-time monitoring and dynamic adjustment of drug activity, enhancing the system's intelligence level.

[0038] In the field of nuclear medicine, traditional radiopharmaceutical dosage calculation often relies on manual operation. This method is not only inefficient and prone to errors, but also lacks systematic data storage and subsequent analysis capabilities, making it difficult to meet the high standards of accuracy and safety required by modern medicine. However, the radiopharmaceutical dosage calculation device for pre-injection imaging analysis of this invention, through communication connection with an activity measurement unit and an input unit, constitutes a radiopharmaceutical dosage control system, realizing fully automated management of the entire process from drug activity measurement to patient information acquisition and dosage calculation. This system can not only accurately measure the current activity of the radiopharmaceutical in the storage vial in real time, but also automatically calculate the personalized injection volume based on the patient's weight, height, and other physiological parameters, ensuring the accuracy of each dose; at the same time, all data in the operation process is digitally recorded, facilitating future retrieval and analysis, thus providing medical staff with detailed historical medication records to support the optimization of treatment plans. This design not only improves the accuracy of drug dosage calculation, but also significantly enhances the system's operational efficiency and user experience. Through precise activity measurement and accurate patient information entry, the system can quickly generate personalized dosing plans, reducing errors from manual operation, minimizing repeated extractions, and reducing the time medical staff spend frequently in contact with radiopharmaceuticals, thereby improving the safety and effectiveness of diagnosis / treatment. Furthermore, the system's automated management functions can reduce the workload of medical staff, improve the efficiency of medical resource utilization, help optimize medical processes, and enhance the overall level of medical services. Attached Figure Description

[0039] Figure 1 is a hardware connection diagram of a radiopharmaceutical dosage control system according to a preferred embodiment of the present invention.

[0040] Figure 2 is a schematic diagram of the data processing of the processor of the activity measurement unit according to a preferred embodiment of the present invention;

[0041] Figure 3 is a schematic diagram of the operation of a computing device according to a preferred embodiment of the present invention;

[0042] Figure 4 is a schematic diagram of the standard curve and safety range of a preferred embodiment of the present invention;

[0043] Figure 5 is a schematic diagram of the operation of a volume measurement unit according to a preferred embodiment of the present invention;

[0044] Figure 6 is a schematic diagram of the operation of a timing unit according to a preferred embodiment of the present invention;

[0045] Figure 7 is a flowchart of the calculation method according to a preferred embodiment of the present invention.

[0046] List of reference numerals: 100: Activity measurement unit; 110: Processor; 120: Detector; 200: Input unit; 210: Input device; 300: Computing device; 400: Medical terminal; 500: Drug storage bottle; 600: Volume measurement unit; 610: Electrode; 700: Timing unit. Detailed Implementation

[0047] The following is a detailed explanation with reference to the accompanying drawings.

[0048] Example 1

[0049] As shown in Figure 1, this invention discloses a radiopharmaceutical dosage control system, comprising: an activity measurement unit 100 for measuring the current radioactivity of the drug in a storage bottle 500; an input unit 200 for acquiring relevant basic information of the current patient; and a calculation device 300 for determining the required volume of drug to be injected for the current patient based on the radioactivity of the drug in the storage bottle 500 and the relevant basic information of the current patient. Further, the calculation device 300 of this invention is particularly useful for analyzing radiopharmaceutical dosage before imaging injection. Preferably, the relevant basic information of the current patient may include the patient's weight and height. More preferably, the aforementioned relevant basic information may also include the patient's age. Preferably, the storage bottle 500 of this invention is typically a glass container and can be placed inside a lead can or lead box to effectively shield the radiation released by the radioactive material, reducing the impact on the surrounding environment and personnel. The storage bottle 500 may be, for example, a vial or ampoule.

[0050] Preferably, the activity measurement unit 100 relies on a high-precision radiation detector to measure radioactivity. Depending on the application scenario and technical requirements, the activity measurement unit 100 can select different types of detectors 120, such as scintillator detectors and semiconductor detectors. Preferably, the scintillator detector utilizes the property of a specific material (such as NaI(Tl), an inorganic scintillator composed of sodium iodide crystals doped with thallium) to absorb radiation and then emit fluorescence to achieve activity measurement. When gamma rays emitted by a radioactive material pass through the crystal, they excite the crystal to produce fluorescence, which is converted into an electrical signal by a photomultiplier tube, amplified, and recorded. This method has high detection efficiency and good energy resolution, and is suitable for measuring various radionuclides. Preferably, semiconductor detectors, especially high-purity germanium (HPGe) detectors, are widely used in precise measurements due to their excellent energy resolution. The HPGe detector works by generating electron-hole pairs when gamma rays enter a germanium crystal under low-temperature conditions. These charge carriers move under the influence of an applied electric field to form current pulses, which, after amplification and processing, provide the energy information of the radiation. Compared to scintillator detectors, HPGe detectors can more accurately distinguish between rays of different energies, making them particularly suitable for precision measurements of low-activity samples.

[0051] Preferably, the electrical signal generated by the detector 120 can be converted into a digital signal by an analog-to-digital converter (ADC), and then transmitted to the processor 110 of the activity measurement unit 100 via a standard interface (such as USB, Ethernet, or a dedicated data bus). Furthermore, in this process, the stability and speed of signal transmission should be ensured to enable real-time monitoring.

[0052] Preferably, the activity measurement unit 100 may also be equipped with a cooling device and a stable power supply to ensure that the detector 120 maintains optimal performance throughout its service life, especially for HPGe detectors that require a low-temperature environment to operate normally.

[0053] Preferably, to obtain the most accurate measurement results, the detector 120 of the activity measurement unit 100 can be positioned at a dedicated measurement point within the storage area of ​​the drug storage bottle 500. This dedicated measurement point should be as close as possible to the corresponding drug storage bottle 500 to ensure that each sample to be tested is correctly placed in front of the detector 120. Furthermore, to protect operators from unnecessary radiation exposure, sufficient radiation shielding, such as lead plates or other heavy-duty shielding materials, should be provided around the detector 120.

[0054] Preferably, the raw signal collected by the detector 120 is converted and sent to the processor 110 of the activity measurement unit 100. The signal is processed by the algorithm built into the processor 110 of the activity measurement unit 100, including noise filtering, baseline correction and other steps, to calculate the radioactivity of the drug. The data processing steps of the processor 110 of the activity measurement unit 100 are shown in Figure 2.

[0055] Preferably, in the noise filtering step, the processor 110 of the activity measurement unit 100 can use a combination of low-pass filtering and median filtering to complementarily remove different types of noise and improve signal quality. Low-pass filtering can remove high-frequency noise, such as electromagnetic interference. In radioactivity detection, signals above the cutoff frequency are filtered out by setting a cutoff frequency to effectively remove electronic noise and environmental interference. Median filtering can remove spike noise, such as transient interference caused by cosmic rays. Median filtering can effectively remove spike noise by smoothing the median of the signal within a certain window.

[0056] Preferably, in the baseline correction step, the processor 110 of the activity measurement unit 100 can correct baseline drift and baseline offset respectively. Baseline drift refers to the slow change of the signal baseline caused by factors such as temperature changes and power fluctuations, while baseline offset refers to the overall upward or downward movement of the signal. Preferably, the processor 110 of the activity measurement unit 100 can use a polynomial fitting method to correct baseline drift, because in radioactivity detection, it can more flexibly adapt to baseline changes, especially when the baseline drift is complex. The polynomial fitting method uses a low-order polynomial (such as a first-order or second-order polynomial) to fit the baseline, and then subtracts the fitted baseline from the original signal to obtain the corrected signal, thereby effectively removing the slowly changing baseline drift. Preferably, the processor 110 of the activity measurement unit 100 can use a reference signal correction method to correct baseline drift, because it can provide higher accuracy in radioactivity detection, especially when quantitative analysis is required. The reference signal correction method uses a known reference signal for comparison, adjusting the signal baseline to be consistent with the reference signal to ensure high-precision measurement.

[0057] Preferably, in the step of calculating the radioactivity of the drug, the processor 110 of the activity measurement unit 100 can obtain the total energy or total count of the signal by integrating the calibrated signal. In radioactivity detection, the gradient method can be used for numerical integration because it is simple to calculate and can meet the accuracy requirements in most cases.

[0058] Preferably, the processor 110 of the activity measurement unit 100 can calculate the radioactivity of the drug based on the integration result and known physical parameters, using the following formula:

[0059] In the formula, A is the radioactivity, measured in mCi; N is the count detected within time t; ε is the detector efficiency; and t is the measurement time.

[0060] Preferably, detector efficiency refers to the ratio of the number of rays that detector 120 can detect to the number of rays actually emitted. It reflects the detector 120's response capability to rays of specific energy and type, and is usually determined through experimental calibration. Furthermore, the processor 110 of the activity measurement unit 100 may also be equipped with a calibration factor k for correcting the measurement results to compensate for possible systematic errors during the measurement process. These errors may originate from factors such as the characteristics of the detector 120 itself, environmental conditions, and measurement methods. The calibration factor can also be determined through experimental calibration. Therefore, the formula for calculating the corrected radioactivity is:

[0061] In the formula, k is the calibration factor.

[0062] Preferably, the data processed by the processor 110 of the activity measurement unit 100 can be expressed in internationally recognized units of radioactivity (usually mCi) and displayed to the user through a graphical interface. Preferably, the processor 110 of the activity measurement unit 100 can communicate with the medical terminal 400, allowing the interface of the medical terminal 400 to display key parameters, such as the currently measured activity value and reference range, and also provide a historical data query function to help users understand the changing trend of drug activity. Preferably, when the measurement result exceeds the preset safety range, the processor 110 of the activity measurement unit 100 can automatically trigger an alarm to alert the operator. The alarm can be presented visually (e.g., a red warning light), audibly (e.g., a buzzer), or a combination of both, ensuring rapid attention even in noisy environments. Furthermore, the alarm can also be triggered via the medical terminal 400.

[0063] Preferably, the activity measuring unit 100 can be communicatively connected to the computing device 300 so that the activity value currently measured by the activity detection unit can be sent to the computing device 300, thereby facilitating the computing device 300 to calculate the amount of medicine taken.

[0064] Preferably, to ensure measurement accuracy, the activity measurement unit 100 can be calibrated periodically, and the calibration process and results can be recorded. Furthermore, a detailed maintenance plan can be developed, including cleaning, inspection, and replacement of damaged parts, to ensure long-term stable operation of the equipment.

[0065] Preferably, to ensure system efficiency and data accuracy, the input unit 200, responsible for collecting and verifying patients' basic information and medical history, is designed to balance user-friendliness, data verification, and privacy protection. Preferably, the input unit 200 may be configured with a digital input device 210, which may be built into the healthcare terminal 400. This input device 210 may be, for example, a touchscreen or a keyboard. Preferably, when the input device 210 of the input unit 200 is a touchscreen, a capacitive touchscreen offers better sensitivity and response speed, making it more suitable for use in a medical environment. Preferably, when the input device 210 of the input unit 200 is a keyboard, it can be a standard QWERTY keyboard or a simplified keyboard specifically designed for a medical environment, suitable for situations involving large amounts of text input.

[0066] Preferably, the patient data input through the input unit 200 can be stored in a structured format to facilitate data exchange with the computing device 300. Preferably, the data storage format may include relational databases (such as MySQL and PostgreSQL) and NoSQL databases (such as MongoDB), wherein relational databases are suitable for structured data and support complex queries and transaction processing; NoSQL databases are suitable for unstructured or semi-structured data and support high-concurrency access and distributed storage.

[0067] Preferably, the input unit 200 can verify the accuracy of the relevant basic information input through the input device 210. For example, it can limit the input data by setting a reasonable numerical range to avoid the input of erroneous data. For example, for age information, the input unit 200 can limit it to 0-130 years old; for weight, the input unit 200 can limit it to 0-500 kg; and for height, the input unit 200 can limit it to 0-250 cm.

[0068] Preferably, data transmission between the input unit 200 and the computing device 300 should employ secure and reliable protocols, such as HTTPS and TLS, to ensure the security and integrity of data during transmission. Simultaneously, the system must comply with relevant medical data protection laws and regulations to safeguard the security of patient personal information.

[0069] Preferably, the computing device 300 may be configured with a high-performance CPU to process data from the activity measurement unit 100 and the input unit 200, thereby calculating and determining the required volume of drug to be injected for the patient. Preferably, a multi-core CPU can process multiple tasks in parallel, improving computational efficiency, and a high-frequency CPU can execute a single task faster, shortening computation time. Preferably, the computing device 300 may be provided with sufficient memory (e.g., at least 16GB of RAM) to store and process large amounts of data, wherein high-speed memory can improve data read and write speeds and enhance system performance. Preferably, the computing device 300 may be provided with a reliable storage device to store patient data and calculation results, wherein the storage device may have a large capacity (e.g., at least 500GB) of storage space to accommodate a large number of data files and log records.

[0070] Preferably, the computing device 300 can communicate with the activity measurement unit 100 and the input unit 200 via wired and / or wireless means. Wired connections may include Ethernet connections suitable for long-distance transmission and USB connections suitable for short-distance transmission; wireless connections may include Wi-Fi connections suitable for scenarios requiring mobility and Bluetooth connections suitable for short-range, low-power device communication. Preferably, data reception by the computing device 300 can be achieved through standardized communication protocols (such as TCP / IP and HTTP) to ensure data integrity and security. Further, the computing device 300 can verify the received data to ensure its accuracy and integrity. After verification, the data can undergo preprocessing operations such as data cleaning, format conversion, and normalization to prepare for subsequent algorithm calculations. Data cleaning removes invalid or erroneous data to ensure data quality; format conversion converts data from different sources into a unified format for easier processing; and normalization scales the data to a uniform range, improving the convergence speed and accuracy of the algorithm.

[0071] Preferably, as shown in Figure 3, the computing device 300 may have a built-in data lookup table based on experience, and different types of radiopharmaceuticals may have corresponding data lookup tables. Exemplarily, the radiopharmaceutical dosage control system of the present invention may be applicable to radiopharmaceuticals including, but not limited to, 18F-FDG, TSPO, AV45, and AV133, wherein the radioactive isotope of the above four radiopharmaceuticals is 18F, and its half-life is approximately 110 minutes. Preferably, 18F-FDG is 2-[18F]fluoro-2-deoxy-D-glucose, the most commonly used positron emission tomography (PET) tracer, mainly used for diagnosis in oncology, neurology, and cardiology. It is taken up by cells and phosphorylated intracellularly by mimicking the metabolic pathway of glucose, thereby displaying the metabolic activity of cells in PET images. Studies have shown that fasting can significantly affect the metabolism and imaging contrast of 18F-FDG. During fasting, the body's metabolic substrate shifts from glucose to free fatty acids; this metabolic shift can inhibit the physiological uptake of myocardium, thereby improving the contrast of 18F-FDG in cardiology and cancer imaging. (Ahmadpour, S., Hosseinimehr, S., & Habibi, M. (2022). Various Aspects of Fasting on the Biodistribution of Radiopharmaceuticals. Current drug metabolism.) Preferably, TSPO is a [18F]TSPO ligand used in PET imaging, primarily to assess brain inflammation and neurodegenerative diseases such as Alzheimer's and Parkinson's. The TSPO ligand can bind to the translocase protein (TSPO) on mitochondria, thereby reflecting the degree of cellular inflammation and damage. Research on TSPO radiopharmaceuticals mainly focuses on optimizing the pharmacokinetic parameters of other radiopharmaceuticals. Through physiological pharmacokinetic (PBPK) models, the distribution and uptake of radiopharmaceuticals in vivo can be simulated and predicted, thereby optimizing treatment regimens.(Abdollahi, H., Fele-Paranj, A., Saboury, B., Uribe, C., & Rahmim, A. (2023). Radiobiological-guided radiopharmaceutical therapy: Radiopharmacokinetic parameter optimization using PBPK modeling. 2023 IEEE Nuclear Science Symposium, Medical Imaging Conference and International Symposium on Room-Temperature Semiconductor Detectors (NSS MIC RTSD), 1-1.) Preferably, AV45 is [18F]Florbetapir, a β-amyloid (Aβ) tracer used in PET imaging, primarily for the early diagnosis of Alzheimer's disease. It specifically binds to Aβ plaques in the brain, thereby displaying the distribution of these plaques in PET images. AV45 is mainly used in imaging studies of Alzheimer's disease. Similar radiopharmaceutical studies have shown that pharmacokinetic parameters such as binding rate, internalization rate, and serum protein binding rate have a significant impact on the biodistribution and effective dose of the drug. (Siebinga, H., De Wit-Van Der Veen, B., Stokkel, M., Huitema, A., & Hendrikx, J. (2022). Current use and future potential of (physiologically based) pharmacokinetic modelling of radiopharmaceuticals: a review. Theranostics, 12, 7804-7820.) Preferably, AV133 is [18F]Flutemetamol. AV133 is another β-amyloid (Aβ) tracer used for PET imaging, primarily for the diagnosis of Alzheimer's disease. It specifically binds to Aβ plaques in the brain, thereby displaying the distribution of plaques in PET images. The metabolism and accumulation of these four radiopharmaceuticals are significantly affected by patient physiological parameters: 18F-FDG: blood glucose (BG) and insulin sensitivity index (ISI) need to be corrected; TSPO ligand: liver enzyme activity (LEA) needs to be corrected; AV45 and AV133: renal function (GFR) and blood glucose (BG) need to be corrected.(Abdollahi, H., Yousefirizi, F., Shiri, I., Brosch-Lenz, J., Mollaheydar, E., Fele-Paranj, A., Shi, K., Zaidi, H., Alberts, I., Soltani, M., Uribe, C., Saboury, B., & Rahmim, A. (2024).Theranostic digital twins: Concept, framework and roadmap towards personalized radiopharmaceutical therapies. Theranostics, 14, 3404-3422.).

[0072] For example, the following is a partial data lookup table for the four radiopharmaceuticals mentioned above.

[0073] Preferably, as shown in Figure 3, the computing device 300 can calculate the dose of the radiopharmaceutical based on the patient's specific physiological parameters and the specific activity of the drug. The patient's specific physiological parameters may, for example, be body surface area (BSA). Preferably, the body surface area can be calculated using the following formula: BSA = 0.007184 × H 0.725 ×W 0.425 ,

[0074] In the formula, BSA is the body surface area in square meters; H is the height in centimeters; and W is the weight in kilograms.

[0075] Preferably, once the body surface area is obtained, it can be used to calculate the dose of a radiopharmaceutical. Typically, the dose of the drug specifies the activity required per unit body surface area. Therefore, if the recommended dose of a drug is αmCi / m², the dose can be calculated accordingly. 2 The total activity dose D that the patient should receive can be calculated using the total activity dose formula: D = α × BSA.

[0076] Furthermore, the recommended dose α of a drug can be determined through methods such as literature and guidelines, clinical trial data and / or pharmacokinetic and pharmacodynamic models, among which different types of drugs may have corresponding recommended dose α.

[0077] In nuclear medicine practice, calculating the dosage of radiopharmaceuticals is a crucial step in ensuring diagnostic / therapeutic efficacy and patient safety. However, current technologies have significant limitations when dealing with radiopharmaceuticals with diverse characteristics. On the one hand, the complexity of radiopharmaceuticals—including but not limited to their half-life, emitted particle type (e.g., gamma rays, beta particles), chemical properties, and biodistribution characteristics—means that the required dosage varies for each drug. On the other hand, most existing dosage calculation methods fail to adequately consider the diversity of these drug characteristics, resulting in recommended dosages often based on fixed patterns or empirical formulas, lacking targeted correction mechanisms. For example, when dealing with radioisotopes with different half-lives, current technologies struggle to adjust in real-time based on the drug's activity changing over time; similarly, for radiopharmaceuticals with strong affinity for specific tissues, current practices do not provide sufficient flexibility to adapt to individualized diagnostic / therapeutic needs. Furthermore, traditional dosage calculation methods typically rely on manual parameter input and offline processing, which not only increases the risk of human error but also limits the effective use of historical data, failing to support post-analysis and optimization.

[0078] Preferably, the computing device 300 of the present invention can simultaneously use the aforementioned data lookup table and numerical calculation to accurately determine the total activity dose D that the patient should receive. For different types of radiopharmaceuticals, the computing device 300 can generate at least two standard curves from different data sources. Further, the computing device 300 can generate a first standard curve based on data from the corresponding data lookup table, and a second standard curve based on a total activity dose formula with a pre-set standard recommended dose as a coefficient for a specific drug type and diagnostic / therapeutic purpose. Both the first and second standard curves can use body surface area (BSA) as the abscissa and the total activity dose D as the ordinate, thus forming two non-overlapping standard curves in the same coordinate system, and a safety range is formed by the envelope of these two standard curves.

[0079] Preferably, the accuracy of the total activity dose D to be received by the patient determined by simply using a data lookup table or numerical calculation is not very high. This is because the above single methods rely heavily on clinical experience data but do not make corrections based on the individual circumstances of the patient. As a result, the total activity dose actually received by the patient does not match the total activity dose required to be received. This situation may lead to problems such as poor imaging results during PET-CT, as recorded in the following paper: Botkin CD, Osman M M. Prevalence, challenges, and solutions for (18) F-FDG PET studies of obese patients: a technologist's perspective. [J]. Journal of Nuclear Medicine Technology, 2007, 35(2): 80. However, if the obtained total activity dose D is simply corrected, it is difficult to determine whether the corrected value is reasonable. Therefore, the purpose of setting a safety range in this invention is to adjust the total activity dose D based on the drug type and the patient's individual circumstances. Specifically, the calculation result of the total activity dose D can be corrected by adjusting the recommended dose α, thereby determining whether the corrected calculation result falls within the safety range. If the corrected calculation result falls within the safety range, it can be used as the dosage of the radiopharmaceutical. If the corrected calculation result does not fall within the safety range, an alarm is issued, and the patient is carefully reassessed by medical personnel. Furthermore, the calculation device 300 can set a neutral range outside the safety range between the two standard curves. This neutral range serves as an additional safety margin to address potential uncertainties and variations. The deviation of the neutral range from the boundary value of the safety range can be determined based on specific clinical experience and practice. Optionally, considering the safety and effectiveness of nuclear medicine, the deviation of the neutral interval from the boundary value of the safe interval can be set to ±5% to ±10%, where +5% to +10% is the deviation of the upper boundary value of the neutral interval from the upper boundary value of the safe interval, and -5% to -10% is the deviation of the lower boundary value of the neutral interval from the lower boundary value of the safe interval. The area between the upper and lower boundary values ​​of the neutral interval, excluding the area of ​​the safe interval, constitutes the neutral interval. In scenarios where the diagnostic purpose is relatively simpler, the combined interval formed by the neutral interval and the safe interval can be used as the basis for judging the corrected calculation result.

[0080] Preferably, the computing device 300 can adjust the recommended dose α or directly adjust the total activity dose D based on the drug type and the patient's individual circumstances. The patient's individual circumstances refer to physiological parameters related to the drug type, primarily considering one or more physiological parameters that have the most significant impact on the metabolism and accumulation of the corresponding type of radiopharmaceutical. Preferably, several physiological parameters affecting the metabolism and accumulation of a certain type of drug can be ranked by their degree of influence to identify one or more physiological parameters with relatively higher influence, which can then be used to adjust the recommended dose α or the total activity dose D.

[0081] For example, a patient's blood glucose level and insulin sensitivity index significantly affect the metabolism and accumulation of 18F-FDG (2-[18F]fluoro-2-deoxy-D-glucose); a patient's liver enzyme activity significantly affects the metabolism and accumulation of TSPO (transloprotein); a patient's renal clearance and blood glucose significantly affect the metabolism and accumulation of AV45 ([18F]Florbetapir); and a patient's renal clearance and blood glucose significantly affect the metabolism and accumulation of AV133 ([18F]Flutemetamol). Further, physiological parameters related to the above four radiopharmaceuticals may include blood glucose level (BG), insulin sensitivity index (ISI), liver enzyme activity (LEA), and glomerular filtration rate (GFR) to respectively form a blood glucose level correction factor (C). BG ), insulin sensitivity index correction factor (C) ISI ), liver enzyme activity correction factor (C) LEA Glomerular filtration rate correction factor (C) GFR For example, the four correction factors mentioned above can be set as follows:

[0082] Therefore, for 18F-FDG (2-[18F]fluoro-2-deoxy-D-glucose), the total correction factor is: C 18F-FDG =C BG ×C ISI For TSPO (transposable protein), the total correction factor is: C TSPO =C LEA For AV45([18F]Florbetapir), the total correction factor is: C AV45 =C BG ×C GFR For AV133 ([18F]Flutemetamol), the total correction factor is: C AV133 =C BG ×C GFRBased on this, the corrected total activity dose D can be obtained according to the drug type and the patient's individual circumstances.

[0083] As shown in Figure 4, a first standard curve is generated based on data from the corresponding data lookup table in a coordinate system with body surface area (BSA) as the abscissa and total active dose (D) as the ordinate. A second standard curve is generated based on the total active dose formula, which uses a pre-defined standard recommended dose as a coefficient for a specific drug type and diagnostic purpose. A safety range is then formed by the envelope of the first and second standard curves. Finally, the total active dose (D) can be adjusted according to the drug type and the patient's individual circumstances to determine whether the adjusted D is above, within, or below the safety range. Furthermore, if the result indicates that the adjusted D is within the safety range, it means that the adjusted dose is within the recommended safety range, implying that the dose is considered standard and has a reasonable risk-benefit balance given the body surface area and patient characteristics. In other words, under normal circumstances, this dose is acceptable and can continue to be used. If the result of the judgment is that the corrected total activity dose D is above the safe range, it means that the corrected dose is higher than the recommended safe range, which may bring a higher risk of toxicity or adverse reactions, exceeding the diagnostic safety limit. A first alert needs to be issued to remind healthcare professionals to carefully consider whether the dose can be adjusted or other measures taken to reduce the potential risks, or to assess whether such a high dose is indeed necessary. If the result of the judgment is that the corrected total activity dose D is below the safe range, it means that the corrected dose is lower than the recommended safe range, which may lead to insufficient diagnostic effect because the dose may not be sufficient to achieve the required therapeutic effect. A second alert needs to be issued to remind healthcare professionals to assess whether the dose should be increased to ensure the effectiveness of the diagnosis while remaining within the safe limits. Furthermore, the total activity dose D corrected by the above method can be used for comparison with the safe range. Preferably, the above safe range can also be replaced by a combined range consisting of the neutral range and the safe range.

[0084] Preferably, as shown in FIG. 5, the radiopharmaceutical dosage control system of the present invention may further include a volume measurement unit 600 for measuring the current residual volume of the drug in the storage bottle 500. The volume measurement unit 600 may employ ultrasonic volume measurement technology, capacitive volume measurement technology, or optical volume measurement technology to measure the drug volume. Furthermore, considering that the top of the storage bottle 500 containing the radiopharmaceutical is equipped with a rubber stopper and aluminum foil, when using ultrasonic volume measurement technology and optical volume measurement technology, the sensor needs to be perpendicularly aligned with the liquid surface to emit ultrasonic waves or light, which is difficult to penetrate the rubber stopper and aluminum foil at the top of the storage bottle 500, affecting the measurement accuracy. Therefore, the non-contact capacitive volume measurement technology can arrange the electrode 610 outside the storage bottle 500, determining the liquid volume by measuring the influence of the liquid on the electric field. This method does not require the electrode 610 to directly contact the liquid, reducing the risk of liquid contamination and is suitable for measuring sensitive liquids (such as radiopharmaceuticals). Furthermore, as shown in Figure 5, the electrode 610 arranged outside the medicine storage bottle 500 can be a ring electrode so as to uniformly surround the bottle body.

[0085] Preferably, the calculation device 300 can calculate the current activity concentration of the drug in the drug storage bottle 500 based on the current activity and volume of the drug in the storage bottle 500, and the calculation formula is as follows:

[0086] In the formula, C is the current activity concentration of the drug in the 500-liter storage bottle, A is the current activity of the drug in the 500-liter storage bottle, and V is the concentration of the drug. 残余 This refers to the residual volume of the medicine within the 500-liter storage bottle.

[0087] Furthermore, the calculation device 300 can calculate the required drug volume for the patient based on the total drug activity to be received and the current drug activity concentration in the storage bottle 500, using the following formula:

[0088] In the formula, V 所需 D is the volume of drug required by the patient, C is the total drug activity that the patient should receive, and D is the current activity concentration of the drug within 500 of the storage bottle.

[0089] Preferably, the radiopharmaceutical dosage control system of the present invention may have a separate display unit near the storage area of ​​the drug storage bottle 500, and / or an integrated display unit on the medical end 400, so as to display the calculation results to the medical staff through the display unit, thereby facilitating the medical staff to manually complete the drug dosage according to the calculated drug volume required by the patient.

[0090] Preferably, the radiopharmaceutical dosage control system of the present invention may further include a drug-dispensing robotic arm for automatically dispensing medication according to a control signal generated by the computing device 300, wherein the computing device 300 can generate a control signal for driving the drug-dispensing robotic arm based on the volume of medication required by the patient calculated from the results. Preferably, the drug-dispensing robotic arm may include a stepper motor for precisely controlling the movement of the piston to extract a specified volume of medication. Preferably, the drug-dispensing robotic arm may include data acquisition elements such as position sensors and pressure sensors for real-time monitoring of the piston's position and pressure. Preferably, the drug-dispensing robotic arm may include a microcontroller communicatively connected to the computing device 300 to control the stepper motor and sensors to execute control logic according to the control signal.

[0091] Preferably, medical staff can input and modify prescription information through the user interface of the medical staff terminal 400, and patients can view their examination information and medication dosages through the patient terminal interface. When the system is running, it should be able to notify doctors and patients in real time of important updates or alerts regarding medication dosages.

[0092] Preferably, as shown in FIG6, the radiopharmaceutical dosage control system of the present invention may be provided with a timing unit 700 for starting timing when the computing device 300 obtains the calculation result. The timing unit 700 may set different interval durations for different types and states of drugs. If the drug measurement is not completed before the set interval duration is exceeded, the drug measurement operation is deemed invalid, and the timing unit 700 sends an invalid signal to the computing device 300 so that the computing device 300 can recalculate according to the current situation. Preferably, the timing unit 700 may adjust the interval duration of each drug in real time based on parameters such as the drug's half-life, current activity value, and allowable maximum activity loss. The allowable maximum activity loss may be calculated by the computing device 300 based on a preset maximum error value when calculating the drug volume.

[0093] The decay formula for radiopharmaceuticals is: A(t) = Ae -λt ,

[0094] In the formula, A(t) is the activity of the drug at time t, A is the current activity of the drug, λ is the decay constant, t is time, and e is the base of the natural logarithm.

[0095] decay constant λ and half-life T 1 / 2 The relationship is:

[0096] Therefore, the timing unit 700 can be set with the interval duration according to the following formula:

[0097] In the formula, T 1 / 2 Let A be the half-life of the drug, and A be the current activity of the drug. targetThis is the deviated activity of the drug. Furthermore, the deviated activity of the drug can be obtained by subtracting a preset maximum allowable activity loss from the current activity of the drug.

[0098] For example, if the maximum allowable activity loss is simply set to 0.03A, it can be calculated that drugs with a half-life of 110 minutes, such as 18F-FDG, need to be taken out within about 5 minutes after the calculation device 300 outputs the calculation results; drugs with a half-life of 68 minutes, such as 68Ga, need to be taken out within about 3 minutes after the calculation device 300 outputs the calculation results.

[0099] The radiopharmaceutical dosage control system of the present invention, equipped with a timing unit 700, is particularly suitable for drugs with short half-lives. Such drugs require extremely high dosage accuracy during use. Therefore, the timing unit 700, which can flexibly set an appropriate interval according to the type and state of the drug being measured, can well ensure that the measurement operation performed according to the calculation results output by the calculation device 300 can meet the accuracy requirements.

[0100] Preferably, the radiopharmaceutical dosage control system of the present invention may be equipped with a radioactive surface contamination measuring device to measure the radioactive residue on the work surface where the drug storage bottle 500 is located, ensuring the safety of the operating environment. Real-time monitoring allows for timely detection and handling of radioactive contamination, preventing environmental pollution and radiation hazards to operators. Preferably, the radioactive surface contamination measuring device may use a Geiger-Müller (GM) counter or a semiconductor detector. A GM counter is a gas discharge tube; when radioactive particles pass through the gas inside the tube, it causes the release and amplification of electrons, generating an electrical signal. The GM counter has high sensitivity to α and β particles. A semiconductor detector (such as a silicon PIN detector) measures the radioactivity level by detecting the charge generated by radioactive particles in a semiconductor material. Semiconductor detectors have higher energy resolution and sensitivity. Preferably, the radioactive surface contamination measuring device may be installed near the work surface where the drug storage bottle 500 is located, ensuring coverage of the entire operating area. Preferably, the data acquired by the radioactive surface contamination measuring device may be sent to a computing device 300 for data processing, to determine the radioactive residue on the work surface based on a threshold set by the computing device 300. When the radioactivity level exceeds the threshold, an alarm is triggered.

[0101] Example 2

[0102] This embodiment is a further improvement on embodiment 1, and repeated content will not be described again.

[0103] As shown in Figure 7, this invention also discloses a method for calculating the dosage of radiopharmaceuticals for pre-injection imaging analysis, which includes the following steps:

[0104] Obtain the current radioactivity of the drug in the storage bottle 500 and the weight and height of the patient currently receiving the drug;

[0105] The first standard curve is generated based on data from a built-in data lookup table of different types of radiopharmaceuticals, which is based on experience and summarized from the data.

[0106] A second standard curve is generated based on a total activity dose formula that uses a pre-defined standard recommended dose as a coefficient for a specific drug type and treatment purpose.

[0107] The first and second standard curves are placed in the same coordinate system to form two non-overlapping standard curves that form the safe range for drug administration. The volume of drug required for the current injection of the patient is determined based on the standard curves. Both the first and second standard curves use body surface area as the abscissa and total activity dose as the ordinate.

[0108] Unlike the prior art described in the background section, this invention introduces a dual-track mechanism (combining data lookup tables and formula calculations) and constructs a safety range, solving the problems of lack of quantitative calibration and safety thresholds in the prior art. This ensures that the dose does not deviate from a reasonable range in the imaging scenario and avoids image quality degradation or radiation risks caused by fluctuations in drug properties (such as activity decay).

[0109] Preferably, the recommended dose or total activity dose is adjusted based on the drug type and the patient's individual circumstances, whereby the individual circumstances are physiological parameters related to the patient's metabolism and accumulation of the radiopharmaceutical, including blood glucose levels, insulin sensitivity index, liver enzyme activity, and / or renal clearance. This invention directly addresses the deficiency in prior art that neglects individualized metabolic parameters. By incorporating these parameters (such as blood glucose levels and insulin sensitivity index), the accuracy of dose calculation is enhanced, meeting the dual constraints of dose safety and image clarity in imaging scenarios.

[0110] Preferably, the first standard curve can be generated by retrieving a built-in data lookup table (DLM). The data lookup table is based on experience and stores activity-body surface area mapping data for different types of radiopharmaceuticals (such as 18F-FDG, TSPO, AV45, and AV133) for corresponding diagnostic and treatment purposes. The data points are fitted using an interpolation algorithm (such as linear interpolation or spline interpolation) to generate a curve (the first standard curve) with body surface area as the abscissa and total activity dose as the ordinate.

[0111] Preferably, the first standard curve can be generated according to the pre-set standard recommended dose formula D = α × BSA based on a specific drug type and treatment purpose, where α is the recommended dose coefficient corresponding to the drug type (e.g., α = 3.7 mCi / m for 18F-FDG). 2 ).

[0112] Preferably, the first and second standard curves are superimposed on the same coordinate system to form two partially overlapping curves, and their envelope region is defined as the safety interval. A neutral interval is further set, with its boundary values ​​offset by ±5% to ±10% relative to the upper and lower boundaries of the safety interval, respectively, to provide additional safety margin. This solves the problem of the lack of safety threshold constraints in the prior art, providing robust protection for imaging scenarios and avoiding the accumulation of dose errors.

[0113] Preferably, the corresponding physiological parameter correction factor (such as the blood glucose correction factor C for 18F-FDG) is applied according to the drug type. BG Insulin sensitivity index correction factor C ISI ; Glomerular filtration rate correction factor C of AV45 GFR The corrected recommended dose coefficient is then substituted into the corresponding correction formula. The corrected total activity dose is then calculated by substituting this coefficient into the dose calculation formula.

[0114] Furthermore, a safety check is performed by determining whether the corrected total activity dose falls within the safe or neutral range. If the corrected total activity dose is within the safe range, the process proceeds to the next step. If the corrected total activity dose exceeds the upper limit of the safe range, a first alarm is triggered (e.g., a red warning light and a buzzer), indicating that the dose needs to be reduced. If the corrected total activity dose is below the lower limit of the safe range, a second alarm is triggered, indicating that the dose needs to be increased. This safety check mechanism addresses the shortcomings of the prior art, which relies on dynamic adjustments during the injection process. It achieves precise calculation in a single step, adapting to the time-sensitive requirements of imaging drugs with short half-lives (e.g., 110 minutes for 18F-FDG), and avoiding post-injection adjustments.

[0115] The computing device 300 of the present invention can be used to execute the above-described calculation method. Furthermore, the computing device 300 can be interconnected with other functional units (such as the activity measurement unit 100, input unit 200, volume measurement unit 600, timing unit 700, and / or contamination detection unit) via wired or wireless communication protocols to form an integrated device system, thereby achieving accurate calculation and safe control of radiopharmaceutical dosage. This solves the problem of reliance on manual operation in the prior art, improves efficiency and reduces errors through an automated system, and meets the needs of imaging scenarios for rapid and accurate drug dispensing.

[0116] Preferably, the activity measurement unit 100 may include a high-precision radiation detector group, the core component of which is a high-purity germanium (HPGe) detector or a NaI(Tl) scintillator detector. The detector surface is covered with a lead shielding layer to reduce environmental radiation interference. The detector maintains a stable operating temperature through a cryogenic cooling module (such as a Peltier cooler), and converts the light signal or charge signal generated by X-ray excitation into an analog electrical signal through a photomultiplier tube (PMT) or a semiconductor charge amplifier. After quantization by an analog-to-digital converter (ADC), the analog signal is transmitted to the processor module through a USB 3.0 or Ethernet interface. The processor module embeds a joint algorithm of a low-pass filter and a median filter to perform noise reduction processing on the signal, and eliminates baseline drift through polynomial fitting or reference signal correction methods. Finally, the drug activity value is calculated based on an integral algorithm and a calibration factor (k).

[0117] Preferably, the input unit 200 can adopt a combination design of a capacitive touch screen and a radiation-proof keyboard. The touch screen supports gesture operation and voice input, and the keyboard is optimized for medical scenarios and has a waterproof and stain-resistant coating. The input unit 200 has built-in data verification logic to dynamically verify the numerical range of the patient's weight (0-500kg), height (0-250cm), and age (0-130 years), and transmits the structured data to the computing device 300 via HTTPS / TLS protocol. The computing device 300 consists of a multi-core high-performance CPU (clock speed ≥3.5GHz) and at least 16GB of RAM, and the storage device is a solid-state drive (SSD) with a capacity of ≥500GB, used to store patient data, drug parameters, and historical records. The computing device 300 has an embedded drug type recognition module that matches the corresponding data lookup table (DLM) with a preset drug half-life (e.g., 110 minutes for 18F-FDG) and treatment purpose (e.g., tumor diagnosis or neurodegenerative disease assessment), and calculates the patient's BSA value based on the body surface area (BSA) formula.

[0118] Preferably, the volume measurement unit 600 employs a non-contact capacitive sensor array, with electrodes 610 arranged in a ring around the outside of the drug storage bottle 500. Residual volume is detected by measuring the disturbance of the electric field by the liquid. The sensor data is amplified by a signal conditioning circuit, and the microcontroller calculates the volume value. This value, along with the activity value from the activity measurement unit 100, is then input into the calculation device 300 to calculate the current activity concentration and the required drug volume.

[0119] Preferably, the drug-dispensing robotic arm can be composed of a piston mechanism driven by a stepper motor, equipped with a position sensor and a pressure sensor to provide real-time feedback on the extraction status, and the robotic arm control signal is generated by a computing device 300 and transmitted via an industrial Ethernet.

[0120] Preferably, the timing unit 700 can dynamically adjust the drug dispensing time limit based on the drug half-life formula, and then calculate the allowable drug dispensing interval time using the following formula based on the preset maximum allowable activity loss (e.g., 3%).

[0121] The timing unit 700 is linked to the robotic arm for drug retrieval; if the timeout expires, it triggers an invalid signal and resets the calculation process. This strengthens the design for time sensitivity in imaging scenarios, ensuring accurate calculations on the first attempt and avoiding delays caused by dynamic adjustments in the background technology.

[0122] Preferably, the contamination detection unit integrates a Geiger-Miller counter (GM) and a semiconductor detector, and is installed around the surface of the medicine storage bottle 500 to monitor surface radioactive residues in real time and trigger an alarm based on threshold determination.

[0123] In summary, Embodiment 2 of the present invention effectively overcomes the limitations of the prior art by combining personalized parameter correction, hyperbolic safety interval mechanism and fully automated hardware system, providing an efficient, accurate and safe radiopharmaceutical dosage calculation scheme for imaging diagnosis (such as PET-CT).

[0124] Example 3

[0125] This embodiment is a further improvement on embodiments 1 and 2, and repeated content will not be described again. Specifically, this embodiment relates to a computing device configured to perform the computing method described in embodiment 2.

[0126] The computing device may include a multi-core central processing unit (CPU) with a clock speed ≥ 3.5 GHz, a field-programmable gate array (FPGA), and an embedded digital signal processor (DSP). The multi-core processor can be used for parallel processing of dose calculation and interpolation operations, the FPGA can accelerate the calculation of activity decay models, and the DSP can handle sensor signal filtering and feature extraction.

[0127] The computing device can be equipped with a memory module with a capacity of ≥16GB for caching patient data and intermediate calculation results, and can also be configured with a solid-state drive with a capacity of ≥500GB for storing data lookup tables (including activity-body surface area mapping data for drugs such as 18F-FDG and TSPO), the standard recommended dosage formula D=α×BSA, safety range parameters, drug half-life values, and physiological parameter correction coefficients C. BG / C ISI / C GFR wait.

[0128] The input interface module of this computing device receives drug activity values ​​detected by the activity measurement unit and residual volume data collected by the volume measurement unit via USB 3.0 / Ethernet protocol. It also receives patient weight (0–150 kg), height (0–200 cm), age (0–100 years), and personalized metabolic parameters (blood glucose level, liver enzyme activity, etc.) transmitted by the input unit. All data transmission can be encrypted using HTTPS / TLS.

[0129] The dose calculation module of the computing device can generate a first standard curve through an interpolation algorithm, and at the same time generate a second standard curve based on D=α×BSA. The two curves are superimposed to form a safe range and a neutral range. The module calls the physiological parameter correction coefficient to calculate the corrected total activity dose, and uses a safety verification unit to determine whether the dose falls within the safe range: if it is within the range, a confirmation signal is output to the drug dispensing robotic arm; if it exceeds the upper limit, a red warning light and a buzzer are triggered; if it is below the lower limit, an incremental alarm is triggered.

[0130] The output control module of the computing device can send extraction volume and pressure threshold commands to the drug dispensing robotic arm via industrial Ethernet, and can also synchronize dosage data to the hospital information system.

[0131] The communication module of the computing device works in conjunction with the timing unit to dynamically limit the drug dispensing time based on the drug's half-life (allowing a maximum activity loss of 3%), and automatically resets the process if the timeout is exceeded.

[0132] This computing device can be equipped with redundant power supplies and electromagnetic shielding shells, and can also have built-in temperature / humidity monitors to ensure operational stability. Its hardware structure enables integrated operation of dose calculation, safety verification and system control, meeting the dual requirements of accuracy and timeliness in imaging scenarios.

Claims

1. A method for calculating the dosage of radiopharmaceuticals for pre-injection analysis in imaging, characterized in that, It includes the following steps: Obtain the current radioactivity of the drug in the storage bottle (500) and the weight and height of the patient currently receiving the drug; The first standard curve is generated based on data from a built-in data lookup table of different types of radiopharmaceuticals, which is based on experience and summarized from the data. A second standard curve is generated based on a total activity dose formula that uses a pre-defined standard recommended dose as a coefficient for a specific drug type and treatment purpose. The first and second standard curves are placed in the same coordinate system to form two non-overlapping standard curves that form the safe range for drug administration. The volume of drug required for the current injection of the patient is determined based on the standard curves. Both the first and second standard curves use body surface area as the abscissa and total activity dose as the ordinate.

2. The calculation method according to claim 1, characterized in that, The recommended dose or total activity dose is adjusted based on the type of drug and in conjunction with the patient’s individual circumstances, which are physiological parameters related to the patient’s metabolism and accumulation of the radiopharmaceutical, including blood glucose levels, insulin sensitivity index, liver enzyme activity and / or renal clearance.

3. A device for calculating the dosage of radiopharmaceuticals for pre-injection imaging analysis, characterized in that, The computing device (300) is used to determine the required volume of drug to be injected for the current patient based on the radioactivity of the drug in the drug storage bottle (500) and the relevant basic information of the current patient. After receiving the current radioactivity and the weight and height of the patient currently receiving the medication, the computing device (300) generates a first standard curve based on data from a built-in data lookup table of different types of radiopharmaceuticals, and generates a second standard curve based on a total activity dose formula with a pre-set standard recommended dose as a coefficient for a specific drug type and treatment purpose. Both the first and second standard curves use body surface area as the abscissa and total activity dose as the ordinate, thus forming two non-overlapping standard curves in the same coordinate system, with the envelope forming the safe range for medication.

4. The computing device according to claim 3, characterized in that, The computing device (300) can adjust the recommended dose or total activity dose based on the drug type and in conjunction with the patient's individual circumstances, wherein the individual circumstances are physiological parameters related to the patient's metabolism and accumulation of the radiopharmaceutical, including blood glucose level, insulin sensitivity index, liver enzyme activity and / or renal clearance.

5. The computing device according to claim 3 or 4, characterized in that, After receiving the current radioactivity of the drug in the drug storage bottle (500) and the relevant basic information of the current patient, the computing device (300) can determine the volume of drug to be injected by searching a built-in data lookup table for different types of radiopharmaceuticals based on experience, and / or can determine the volume of drug to be injected by numerical calculation based on the patient's specific physiological parameters and the specific activity of the drug.

6. The computing device according to claims 3 to 5, characterized in that, When the computing device (300) determines the volume of drug to be injected by numerical calculation, the patient-specific physiological parameters it selects include the body surface area calculated based on the patient's height and weight, and the total activity dose that the patient should receive is calculated based on the obtained body surface area and the recommended dose of the corresponding drug.

7. The computing device according to any one of claims 3 to 6, characterized in that, The computing device (300) can receive the current radioactivity of the drug in the drug storage bottle (500) through the activity measurement unit (100). The activity measurement unit (100) deploys a corresponding detector (120) at a dedicated measurement point near the corresponding drug storage bottle (500) in the storage area of ​​the drug storage bottle (500). The original signal collected by the detector (120) is converted and sent to the processor (110) of the activity measurement unit (100) to calculate the radioactivity of the drug after signal processing.

8. The computing device according to any one of claims 3 to 7, characterized in that, The processor (110) of the activity measurement unit (100) integrates the calibrated signal using the gradient method to obtain the total energy or total count of the signal, and then calculates the radioactivity of the drug based on the integration result and physical parameters, wherein the physical parameters include detector efficiency and / or calibration factor.

9. The computing device according to any one of claims 3 to 8, characterized in that, The data processed by the processor (110) of the activity measurement unit (100) can be displayed to the user through a graphical interface. The processor (110) of the activity measurement unit (100) can communicate with the medical terminal (400) so that the interface of the medical terminal (400) can display key parameters including the currently measured activity value and the reference range, and provide a historical data query function.

10. The computing device according to any one of claims 3 to 9, characterized in that, The computing device (300) is communicatively connected to an input unit (200) for obtaining relevant basic information of the current patient receiving medication, so as to receive the weight and height of the current patient receiving medication, wherein the input unit (200) is configured with a digital input device (210).

11. The computing device according to any one of claims 3 to 10, characterized in that, The input unit (200) can verify the accuracy of the relevant basic information input by the input device (210) by setting the numerical range of the corresponding parameters, so that the correct relevant basic information entered in the input unit (200) can be transmitted to the computing device (300) through a secure protocol.

12. The computing device according to any one of claims 3 to 11, characterized in that, The computing device (300) is communicatively connected to a volume measuring unit (600) for measuring the current residual volume of the drug in the drug reservoir (500), wherein the volume measuring unit (600) is equipped with electrodes (610) on the outside of the corresponding drug reservoir (500), thereby enabling the computing device (300) to calculate the volume of drug required by the patient using the residual volume of the drug obtained by the volume measuring unit (600) based on capacitive volume measurement technology.

13. The computing device according to any one of claims 3 to 12, characterized in that, The computing device (300) can communicate with the timing unit (700), which can start timing when the computing device (300) obtains the calculation result. The timing unit (700) can set different interval durations for different types and states of drugs.

14. The computing device according to any one of claims 3 to 13, characterized in that, If the drug measurement is not completed within the set interval, the drug measurement operation is deemed invalid. The timing unit (700) sends an invalid signal to the computing device (300) so that the computing device (300) can recalculate based on the current situation.

15. The computing device according to any one of claims 3 to 14, characterized in that, The timing unit (700) can adjust the interval between each drug in real time based on parameters including the drug's half-life, current activity value, and maximum allowable activity loss. The maximum allowable activity loss can be calculated by the computing device (300) based on a preset maximum error value when calculating the drug volume.

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