Breast cancer diagnosis method and device

Abstract

A breast cancer diagnosis device of the present invention comprises: a memory on which a breast cancer diagnosis program is stored; and a processor for executing the breast cancer diagnosis program, wherein the breast cancer diagnosis program selects at least two from among a first result obtained by diagnosing breast cancer through a chromophore comparison index calculated using a near-infrared breast cancer diagnosis device, a second result obtained by diagnosing breast cancer through an intensity ratio of a chromophore image generated using the near-infrared breast cancer diagnosis device, and a third result based on BI-RADS diagnosis, thereby outputting a breast cancer diagnosis result.

Description

Breast cancer diagnosis method and device

[0001] The present invention relates to a method and device for diagnosing breast cancer.

[0002] Early diagnosis and treatment of disease are crucial for leading a healthy life. Among various diseases, cancer is a serious and potentially life-threatening condition, and interest in its early diagnosis and treatment is growing. Meanwhile, among women, breast cancer has the highest incidence rate among cancers such as breast, thyroid, stomach, colon, and lung. Therefore, there is growing interest in finding ways to effectively diagnose breast cancer early and treat it effectively.

[0003] Looking at the conventional breast cancer diagnosis method, a preliminary diagnosis was performed through mammography, breast ultrasound, or breast MRI, and then a decision was made on whether to perform a biopsy based on the results.

[0004] However, there is a problem that overdiagnosis costs occur due to low sensitivity and specificity.

[0005] Furthermore, mammography presents challenges such as pain due to breast compression during the scan and exposure to radiation during the examination. Breast ultrasound is expensive, and it is difficult to clearly distinguish between breast and benign tumors based on ultrasound images alone. Results vary depending on the examiner's skill. Breast MRI is also expensive and has low specificity, sometimes leading to benign tumors being classified as cancer. The lack of a means to link to diagnostic equipment also presents inconvenience to users.

[0006] To solve these problems, there is a method of diagnosing breast cancer using diffuse optical tomography, which uses light wavelengths to obtain two-dimensional or three-dimensional images of the tissue inside the breast.

[0007] For example, Korean Patent No. 10-2563805 (Title of invention: Breast cancer diagnosis system) discloses a technology for diagnosing breast cancer by sequentially outputting light of multiple wavelengths in the near-infrared region to a target object, analyzing the output light from the target object, calculating the chromophore concentration of the target object, and displaying a chromophore image.

[0008] The purpose of the present invention is to provide a breast cancer diagnosis device and method that quantitatively measures chromophores in a target area within a human body using multi-wavelength near-infrared (DMW-NIRS) spectroscopy technology, provides an index that can determine the benignity and malignancy of a breast tumor, and thereby enables diagnosis of breast cancer.

[0009] However, the technical task that this embodiment seeks to achieve is not limited to the technical task described above, and other technical tasks may exist.

[0010] As a technical means for achieving the above-described technical task, a breast cancer diagnosis device according to a first aspect of the present invention comprises: a memory in which a breast cancer diagnosis program is stored; and a processor for executing the breast cancer diagnosis program, wherein the breast cancer diagnosis program selects at least two of a first result of diagnosing breast cancer using a chromophore comparison index calculated using a near-infrared breast cancer diagnosis device, a second result of diagnosing breast cancer using an intensity ratio of a chromophore image generated using the near-infrared breast cancer diagnosis device, and a third result based on BI-RADS diagnosis to output a breast cancer diagnosis result.

[0011] In addition, a breast cancer diagnosis method performed by a breast cancer diagnosis device according to a second aspect of the present invention includes the steps of: calculating a chromophore comparison index for a subject using a near-infrared breast cancer diagnosis device; calculating an intensity ratio of a chromophore image generated using the near-infrared breast cancer diagnosis device for the subject; receiving a BI-RADS diagnosis result for the subject; and outputting a breast cancer diagnosis result based on at least two of the chromophore comparison index, the intensity ratio, and the BI-RADS diagnosis result.

[0012] Through the present invention, more accurate results can be efficiently produced by utilizing breast cancer diagnosis methods using a near-infrared breast cancer diagnosis device and the existing BI-RADS diagnosis method.

[0013] In particular, it provides information that can be used for breast cancer screening or differential diagnosis of benign / malignant breast cancer through a near-infrared-based breast cancer diagnostic device.

[0014] Figure 1 is a method for diagnosing breast cancer according to one embodiment of the present invention.

[0015] FIG. 2 is a flowchart illustrating a breast cancer diagnosis method according to one embodiment of the present invention.

[0016] FIG. 3 is a drawing for explaining a multi-wavelength near-infrared-based breast cancer diagnosis method applied to the present invention.

[0017] Figure 4 illustrates a chromophore image generated according to a multi-wavelength near-infrared-based breast cancer diagnosis method applied to the present invention.

[0018] Figure 5 illustrates the BI-RADS diagnostic results table.

[0019] Figure 6 is a flowchart illustrating a breast cancer diagnosis method according to one embodiment of the present invention.

[0020] Below, with reference to the attached drawings, embodiments of the present invention are described in detail so that those skilled in the art can easily implement them. However, the present invention may be implemented in various different forms and is not limited to the embodiments described herein. In the drawings, irrelevant parts have been omitted for clarity of description, and similar reference numerals have been used throughout the specification to indicate similar elements.

[0021] Throughout the specification, when a part is said to be "connected" to another part, this includes not only the cases where the parts are "directly connected" but also the cases where the parts are "electrically connected" with other elements intervening. Furthermore, when a part is said to "include" a component, this does not exclude other components, but rather includes other components, unless otherwise stated.

[0022] In this specification, the term 'unit' includes a unit realized by hardware, a unit realized by software, and a unit realized using both. In addition, one unit may be realized by using two or more pieces of hardware, and two or more units may be realized by one piece of hardware. Meanwhile, the '~ unit' is not limited to software or hardware, and the '~ unit' may be configured to be in an addressable storage medium or may be configured to reproduce one or more processors. Therefore, as an example, the '~ unit' includes components such as software components, object-oriented software components, class components, and task components, as well as processes, functions, attributes, procedures, subroutines, segments of program code, drivers, firmware, microcode, circuits, data, databases, data structures, tables, arrays, and variables. The functionality provided within the components and '~sub-units' may be combined into a smaller number of components and '~sub-units' or further separated into additional components and '~sub-units'. Furthermore, the components and '~sub-units' may be implemented to recycle one or more CPUs within the device.

[0023] A network is a connection structure that enables information exchange between each node, such as terminals and servers, and includes a local area network (LAN), a wide area network (WAN), the Internet (WWW), wired and wireless data communication networks, telephone networks, and wired and wireless television communication networks. Examples of wireless data communication networks include, but are not limited to, 3G, 4G, 5G, 3GPP (3rd Generation Partnership Project), LTE (Long Term Evolution), WIMAX (World Interoperability for Microwave Access), Wi-Fi, Bluetooth communication, infrared communication, ultrasonic communication, visible light communication (VLC), LiFi, etc.

[0024] The user terminal may be implemented as a computer or portable terminal capable of accessing the translation device via a network. Here, the computer may include, for example, a notebook, desktop, or laptop equipped with a web browser. The portable terminal may include, for example, any type of handheld-based wireless communication device that guarantees portability and mobility, such as various smartphones and tablet PCs.

[0025] FIG. 1 is a block diagram illustrating the configuration of a breast cancer diagnosis device according to one embodiment of the present invention.

[0026] The breast cancer diagnosis device (100) includes a processor (110) and a memory (120), and may further include a communication module (130) and a database (140). In addition, the breast cancer diagnosis device (100) outputs a breast cancer diagnosis result by integrating the breast cancer diagnosis result using a near-infrared breast cancer diagnosis device and the BI-RADS diagnosis result. The breast cancer diagnosis device (100) may be implemented as a server that provides the breast cancer diagnosis result. When the breast cancer diagnosis device (100) functions as a server, it may operate in a cloud computing service model such as SaaS (Software as a Service), PaaS (Platform as a Service), or IaaS (Infrastructure as a Service). In addition, the breast cancer diagnosis device (100) may be built in a form such as a private cloud, a public cloud, or a hybrid cloud.

[0027] The memory (120) stores a breast cancer diagnosis program. The breast cancer diagnosis program selects at least two of the following results: a first result of diagnosing breast cancer using a chromophore comparison index calculated using a near-infrared breast cancer diagnosis device, a second result of diagnosing breast cancer using an intensity ratio of a chromophore image generated using a near-infrared breast cancer diagnosis device, and a third result based on BI-RADS diagnosis, and outputs a breast cancer diagnosis result.

[0028] In addition, the memory (120) performs the function of temporarily or permanently storing data processed by the processor (110). Here, the memory (120) may include a volatile storage media or a non-volatile storage media, but the scope of the present invention is not limited thereto.

[0029] The processor (110) executes a breast cancer diagnosis program stored in the memory (120). In addition, the processor (110) performs various control operations for the operation of the breast cancer diagnosis device (100). The processor (110) may refer to a data processing device built into hardware, which has a physically structured circuit to perform a function expressed by a code or command included in the program, for example. As an example of a data processing device built into hardware, a microprocessor, a central processing unit (CPU), a processor core, a multiprocessor, an application-specific integrated circuit (ASIC), a field programmable gate array (FPGA), a graphics processing unit (GPU), and the like may be included, but the scope of the present invention is not limited thereto.

[0030] The communication module (130) may include one or more components that enable transmission and reception of various types of data with an external computing device. For example, various information about a subject or BI-RADS diagnostic results may be received through the communication module (130). Furthermore, chromophore-related measurement results may be received from an external near-infrared breast cancer diagnostic device. Furthermore, the final calculated breast cancer diagnostic results may be transmitted to another computing device. The communication module (130) may be a device including the hardware and software necessary to transmit and receive signals, such as control signals or data signals, with other network devices via wired or wireless connections.

[0031] The database (140) can manage various data required for executing a breast cancer diagnosis program. The database (140) can store information on a first result of diagnosing breast cancer using various profile information of the subject or a chromophore comparison index calculated using a near-infrared breast cancer diagnosis device, a second result of diagnosing breast cancer using the intensity ratio of a chromophore image generated using a near-infrared breast cancer diagnosis device, and a third result of diagnosing based on BI-RADS diagnosis.

[0032] FIG. 2 is a flowchart illustrating a breast cancer diagnosis method according to one embodiment of the present invention.

[0033] The breast cancer diagnosis method of the present invention selects at least two of three diagnostic methods and uses them to diagnose breast cancer.

[0034] The first method is a method using a chromophore comparison index generated using a near-infrared breast cancer diagnostic device, the second method is a method using a near-infrared breast cancer diagnostic device to calculate the intensity ratio of individual chromophore images, and the third method is a method using BI-RADS diagnostic results.

[0035] By selecting at least two of these three methods, the breast cancer diagnosis results are output (S140).

[0036] First, let us examine a method of generating an index using a near-infrared breast cancer diagnosis device according to the first method (S110).

[0037] For a detailed configuration of the multi-wavelength near-infrared-based breast cancer diagnosis method of the present invention, refer to the existing registered patent 10-2444393 (Title of invention: Breast cancer diagnosis system).

[0038] FIG. 3 is a drawing for explaining a multi-wavelength near-infrared-based breast cancer diagnosis method applied to the present invention.

[0039] The multi-wavelength near-infrared-based breast cancer diagnosis method irradiates a target with multi-wavelength near-infrared light, detects light reflected / emitted from the target through absorption or scattering in the target, analyzes the detected light to calculate absorption and scattering coefficients, quantitatively calculates the concentration of a chromophore substance, and then calculates the value by comparing the chromophore concentration values ​​between the lesion area (Lesion) and the normal area (Normal), and generates an image that outputs the distribution of chromophore concentration values.

[0040] That is, as illustrated in Fig. 3, a region of the first breast presumed to have a lesion area is irradiated with multi-wavelength near-infrared light, and the light output therefrom is detected and analyzed to produce a chromophore. Then, a region of the second breast corresponding thereto is regarded as a normal region, and multi-wavelength near-infrared light is irradiated to that region, and the light output therefrom is detected and analyzed to produce a chromophore.

[0041] When comparing the chromophore values ​​of tumor and normal tissue, it was observed that hemoglobin (both oxyhemoglobin and deoxyhemoglobin) increased in tumor tissue compared to normal tissue due to angiogenesis, and it is known that changes in the spectrum suggesting changes in the water binding state as well as increases in water content were observed in tumor tissue. It is known that the values ​​of fat and oxygen saturation decrease in tumor tissue compared to normal tissue. The present invention utilizes these characteristics to compare the chromophore concentrations of lesions and normal areas or indices calculated based on chromophores to calculate an index (TOI: Tissue optical index) and utilizes this value for breast cancer diagnosis.

[0042] A specific mathematical formula for calculating the chromophore comparison index of the lesion area (target area) compared to the normal area (control area) can be presented as follows.

[0043] chromophore L / N(Lesion to Normal) Ratio =

[0044] At this time, oxyhemoglobin, deoxyhemoglobin, water, lipids, etc. can be used as chromophore substances, and based on this, various chromophore comparison indices (HbO) that indicate the concentration ratio of the lesion area (target area) to the normal area (control area) of each chromophore substance 2-L / N , HHb L / N , water L / N , lipid L / N ) can be calculated. That is, the oxyhemoglobin comparison index (HbO) which represents the concentration ratio of the lesion area (target area) to the normal area (control area) of oxyhemoglobin 2-L / N ,), deoxyhemoglobin comparison index (HHb), which indicates the concentration ratio of the lesion area (target area) to the normal area (control area) of deoxyhemoglobin L / N ), water comparison index (water comparison index) which indicates the concentration ratio of the lesion area (target area) to the normal area (control area) of water L / N ), lipid comparison index (lipid) which indicates the concentration ratio of the lesion area (target area) to the normal area (control area) of lipid L / N ) can be produced.

[0045] In addition, the total hemoglobin comparison index (THC) was calculated by adding up the concentration values ​​of oxyhemoglobin and deoxyhemoglobin and calculating the concentration ratio of the lesion area (target area) to the normal area (control area) of the total hemoglobin based on the total hemoglobin. L / N ) can be produced.

[0046] In addition, oxygen saturation can be calculated by dividing the concentration value of total hemoglobin by the concentration value of oxyhemoglobin, and the oxygen saturation comparison index (StO) can be calculated by using the oxygen saturation ratio of the lesion area (target area) to the normal area (control area) of oxygen saturation. 2-L / N ,) can be produced.

[0047] In addition, a combination index can be calculated by selecting some of the previously calculated chromophore comparison indices and performing mathematical calculations.

[0048] For example, a composite index can be defined as the product of the deoxyhemoglobin comparison index and the water comparison index and divided by the lipid comparison index. That is, in the case of tumors, hemoglobin (both deoxyhemoglobin and oxyhemoglobin) and water increase and lipid decrease due to angiogenesis compared to normal tissue. Therefore, in light of this trend, the deoxyhemoglobin comparison index and water comparison index increase in tumors, and the lipid comparison index decreases, so the composite index increases in tumor tissue.

[0049] In this way, the combination index can be prepared in a form in which its value increases more in tumor tissue than in normal tissue, and by using this combination index, it is possible to determine whether breast tissue is benign or malignant.

[0050] For example, if the threshold value of the combination index is set to 1, it can be judged as malicious if it exceeds 1, and benign if it is less than 1.

[0051] Next, we will examine a method for calculating the intensity ratio of individual images using a near-infrared breast cancer diagnosis device according to the second method (S120).

[0052] FIG. 4 illustrates a chromophore image generated according to a multi-wavelength near-infrared-based breast cancer diagnosis method applied to the present invention.

[0053] Using a near-infrared breast cancer diagnostic device, as previously discussed, the concentration of chromophore material can be calculated at each location within the target area, and individual images can be generated displaying the concentration of chromophore material at each coordinate. The area containing the breast lesion becomes the target area, and the symmetrical area becomes the control area for comparison.

[0054] The present invention utilizes the intensity ratio of individual images to diagnose breast cancer. In this case, intensity refers to the intensity value of each pixel in the image, and may represent the sum of the intensities of pixels within a given area or the average value of the intensities of the pixels.

[0055] For example, breast cancer can be diagnosed based on the difference between the intensity (IL) of the diagnosis target area and the intensity (IN) of the control area divided by the intensity (IL) of the diagnosis target area.

[0056] <Mathematical Formula 1>

[0057]

[0058] And, if the value calculated in this way is between 0 and the threshold value (α), it can be judged as benign. In other words, since the difference in intensity between the diagnostic target area presumed to have a lesion and the lesion-free control area is not large, the diagnostic target area can be judged as benign. However, if the difference between the diagnostic target area and the control area is large, the value of mathematical expression 1 exceeds the threshold value (α), in which case malignancy can be diagnosed.

[0059] Next, according to the third method (S130), there is a method of using the BI-RADS (Breast Imaging Reporting & Data System) diagnosis results.

[0060] Figure 5 illustrates the BI-RADS diagnostic results table.

[0061] BI-RADS diagnostic results are a multiple-grade system that grades symptoms based on mammography, breast ultrasound, and magnetic resonance imaging (MRI) results used for breast cancer screening and diagnosis.

[0062] Grade 0 indicates an incomplete diagnosis, Grade 1 indicates a negative grade with no abnormal findings, and Grade 2 indicates a definite positive grade. Grade 3 indicates a high probability of being positive and requires a retest after 6 months.

[0063] Grade 4 indicates a suspected malignancy, and is further classified into grades 4a, 4b, and 4c, depending on the degree of malignancy suspected. Grade 5 indicates a very high probability of malignancy, and grade 6 indicates a case diagnosed as malignant by biopsy.

[0064] As such, BI-RADS diagnosis is a diagnostic result by medical professionals such as doctors, and is used to confirm or assist in the benign / malignant judgment results obtained by the first and second methods.

[0065] In the present invention, as shown in FIG. 2, the BI-RADS results determined by mammography or breast ultrasound diagnosis can be received and used to output the final breast cancer diagnosis results. At this time, the BI-RADS results can be received from an external computing device such as a server storing medical information, or can be directly input by the user through the user interface of the breast cancer diagnosis device (100). Meanwhile, the breast cancer diagnosis method of FIG. 2 can be performed internally in the near-infrared breast cancer diagnosis device or through an external computing device.

[0066] Finally, in the step of outputting the breast cancer diagnosis result (S140), if at least two of the diagnosis results of the chromophore comparison index, the diagnosis result by the intensity ratio, and the diagnosis result by BI-RADS diagnose that breast cancer has occurred, the subject is finally diagnosed as having breast cancer. In addition, if one or less of the three diagnosis results diagnose that breast cancer has occurred, the subject is finally diagnosed as not having breast cancer.

[0067] Figure 6 is a flowchart illustrating a breast cancer diagnosis method according to one embodiment of the present invention.

[0068] Unlike the flowchart in Fig. 2, each step is performed sequentially, and the specific details of each step are as described above.

[0069] As illustrated, a step (S110) of calculating a chromophore comparison index for a subject using a near-infrared breast cancer diagnosis device, a step (S120) of calculating an intensity ratio of a chromophore image generated for the subject using the near-infrared breast cancer diagnosis device, and a step (S130) of receiving a BI-RADS diagnosis result for the subject can be sequentially performed.

[0070] And, the breast cancer diagnosis result is output (S140) based on at least two of the chromophore comparison index, intensity ratio, and BI-RADS diagnosis result.

[0071] The method described above can also be implemented in the form of a recording medium containing computer-executable instructions, such as program modules executed by a computer. The computer-readable medium can be any available medium that can be accessed by a computer, and includes both volatile and nonvolatile media, removable and non-removable media. Furthermore, the computer-readable medium can include computer storage media. The computer storage media includes both volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storing information, such as computer-readable instructions, data structures, program modules, or other data.

[0072] Those skilled in the art will appreciate that, based on the above description, the present invention can be readily modified into other specific forms without altering the technical spirit or essential characteristics thereof. Therefore, the embodiments described above should be understood as illustrative in all respects and not restrictive. The scope of the present invention is defined by the following claims, and all changes or modifications derived from the meaning and scope of the claims and their equivalents should be construed as being included within the scope of the present invention.

Claims

1. In a breast cancer diagnosis device, Memory in which the breast cancer diagnosis program is stored; and Including a processor for executing the above breast cancer diagnosis program, The above breast cancer diagnosis program is, A breast cancer diagnosis device, which outputs a breast cancer diagnosis result by selecting at least two of a first result of diagnosing breast cancer using a chromophore comparison index calculated using a near-infrared breast cancer diagnosis device, a second result of diagnosing breast cancer using an intensity ratio of a chromophore image generated using the near-infrared breast cancer diagnosis device, and a third result based on BI-RADS diagnosis.

2. In paragraph 1, The above chromophore comparison index represents the result of comparing the chromophore material of the normal area and the lesion area of ​​the subject's breast. A breast cancer diagnostic device, wherein the chromophore material is at least one of oxyhemoglobin, deoxyhemoglobin, water, lipid, and total hemoglobin.

3. In paragraph 2, The above chromophore comparison index is, A breast cancer diagnostic device, which is calculated based on a combined index generated by dividing the product of the deoxyhemoglobin comparison index and the water comparison index by the lipid comparison index.

4. In paragraph 2, The above chromophore comparison index is, A breast cancer diagnosis device, wherein the oxygen saturation is calculated by dividing the concentration value of total hemoglobin by the concentration value of oxyhemoglobin, and the oxygen saturation is calculated based on a comparison index of oxygen saturation in the normal area and the lesion area.

5. In paragraph 1, A breast cancer diagnostic device, wherein the above intensity ratio is calculated as a value obtained by dividing the difference between the intensity (IL) of the diagnostic target area of ​​the chromophore image and the intensity (IN) of the control area by the intensity (IL) of the diagnostic target area.

6. In paragraph 1, The above breast cancer diagnosis program is, A breast cancer diagnosis device, wherein if at least two of the diagnostic results of the above chromophore comparison index, the diagnostic result by the intensity ratio, and the diagnostic result of BI-RADS are diagnosed as breast cancer, a final diagnosis is made that the subject has breast cancer.

7. A method for diagnosing breast cancer performed by a breast cancer diagnosis device, A step of calculating a chromophore comparison index using a near-infrared breast cancer diagnostic device for a subject; A step of calculating the intensity ratio of a chromophore image generated using the near-infrared breast cancer diagnostic device for the above subject; A step of receiving BI-RADS diagnostic results for the subject; and A method for diagnosing breast cancer, comprising the step of outputting a breast cancer diagnosis result based on at least two of the chromophore comparison index, the intensity ratio, and the BI-RADS diagnosis result.

8. In paragraph 7, The steps for calculating the above chromophore comparison index are: The chromophore comparison index is calculated based on the ratio of the concentration of the chromophore substance in the normal area of ​​the subject's breast and the concentration of the chromophore substance in the lesion area. A method for diagnosing breast cancer, wherein the chromophore substance is at least one of oxyhemoglobin, deoxyhemoglobin, water, lipid, and total hemoglobin.

9. In paragraph 8, The steps for calculating the above chromophore comparison index are: A method for diagnosing breast cancer, wherein a combined index is generated by dividing the product of a deoxyhemoglobin comparison index and a water comparison index by a lipid comparison index, and the result is calculated as the chromophore comparison index.

10. In paragraph 8, The steps for calculating the above chromophore comparison index are: A method for diagnosing breast cancer, wherein the chromophore comparison index is calculated based on the ratio of oxygen saturation in a normal area and oxygen saturation in a lesion area, based on the oxygen saturation calculated by dividing the concentration value of total hemoglobin by the concentration value of oxyhemoglobin.

11. In paragraph 7, The steps for calculating the above intensity ratio are: A method for diagnosing breast cancer, wherein the difference between the intensity (IL) of the target diagnosis area and the intensity (IN) of the control area of ​​the chromophore image is divided by the intensity (IL) of the target diagnosis area to calculate the intensity ratio.

12. In paragraph 7, The step of printing the above breast cancer diagnosis results is: A method for diagnosing breast cancer, wherein if at least two of the diagnostic results of the above chromophore comparison index, the diagnostic result by the intensity ratio, and the diagnostic result by BI-RADS are diagnosed as breast cancer, a final diagnosis is made that the subject has breast cancer.

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