A method for measuring radiation with a triple-channel dosimetry system and an user interface thereof

WO2026170202A1PCT designated stage Publication Date: 2026-08-13ISP INVESTMENTS LLC
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Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2026-02-10
Publication Date
2026-08-13

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Abstract

This present disclosure provides a triple-channel dosimetry system comprising: i) a point dose measurement device comprising a film assembly having at least one radiation sensitive film; ii) a template comprising at least one slot to place the radiation sensitive film; iii) a flatbed optical scanner capable of reflective scanning and capturing optical density data in at least three colors a flatbed optical scanner to capture radiation data of the radiation sensitive film through reflective scanning; and iv) dedicated software configured to process the scanned film data, to perform in-vivo dosimetry measurements dedicated software module enabling in-vivo dosimetry measurements. The present disclosure also provides ana user- interface process for radiation dose calibration, process for radiation dose measurement, and a method of measuring a radiation dose.
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Description

Docket No.: 4476PCTA METHOD FOR MEASURING RADIATION WITH A TRIPLE-CHANNEL DOSIMETRY SYSTEM AND AN USER INTERFACE THEREOFFIELD OF THE INVENTION

[0001] The presently disclosed process(es), procedure(s), method(s), product(s), result(s), and / or concept(s) (collectively referred to hereinafter as the “present disclosure or invention”) relates generally to a triple-channel dosimetry system with a flatbed optical scanner to capture radiation data of the radiation sensitive film through reflective scanning.BACKGROUND OF THE INVENTION

[0002] This invention relates to a triple-channel dosimetry system comprising: i) a point dose measurement device comprising a film assembly having at least one radiation sensitive film; ii) a template comprising at least one slot to place the radiation sensitive film; iii) a flatbed optical scanner to capture radiation data of the radiation sensitive film through reflective scanning; and iv) dedicated software module enabling in-vivo dosimetry measurements.

[0003] Radiotherapy has been used for years as a method for irradiating and selectively killing cancer cells while minimizing radiation exposure to adjacent tissue. The effectiveness of radiotherapy depends upon the absorbed dose or the amount of energy deposited within a tissue mass. Absorbed dose is typically measured in centigray or cGy units.

[0004] A radiation detection medium may be used to determine the amount and location of radiation to which a patient is subjected during radiation treatment. Particularly useful is a two-dimensional radiation detection medium that can determine radiation dose over an area. Examples are radiographic film, radiochromic film, phosphor plates, two-dimensional arrays of diodes or ion chambers and the like. The radiation detection medium typically has a response that varies systematically in accordance with the degree of radiation exposure. After exposure to ionizing radiation, radiation detection media such as radiographic and radiochromic films typically have a light transmission or optical density that varies systematically in proportion to the radiation dose. Calibration of the radiation sensitive film allows one to measure the absorbed dose indirectly by measuring the light transmission or optical density of the exposed radiation detection medium.Docket No.: 4476PCT

[0005] Radiochromic films are widely used by Medical Physicists to perform radiation dosimetry. Film is widely recognized as a “gold standard” for performing radiation dosimetry because of its exceptional spatial resolution, reaching to a level of at least 0.025 mm. Such high resolution is not possible with other measurement modalities including ion chambers, diodes and TLD. These other techniques are limited to spatial resolution in the range of 1 mm or coarser. Another advantage of radiochromic film is its tissue equivalence that the adsorbed radiation dose is truly reflection of the dose adsorbed by tissue.

[0006] In facilities where radiation emitting sources are used, for example, in hospitals where patients receive radiation treatments or in blood banks where blood products are irradiated, various methods are used to quantitatively determine the radiation dose delivered by the source. The methods practiced include the use of thermoluminescent dosimeters (TLD's), ionization-type radiation detectors, photographic film, and radiochromic materials. TLD's are inconvenient because they require a complicated and time-consuming read-out process. Ionization-type radiation detectors are awkward and unwieldy and require a complicated setup. Photographic film requires a time-consuming chemical processing procedure before read-out. Radiochromic materials are preferred because they do not require any post-exposure processing and they are capable of measuring radiation doses with a high spatial resolution, but they are inconvenient in current practice because the calculation of the dose requires a complex sequence of steps, subject to error.

[0007] U.S. Patent No. 5,637,876 describes a radiation dosimeter, exemplarily for use in determining a level of radiation to which a patient is subjected during radiation treatment, which comprises a substrate provided with a layer of radiation sensitive material. The radiation sensitive material has an optical density which varies systematically in accordance with the degree of radiation exposure. The dosimeter may take the form of a card or a flexible substrate which is positionable on the patient or other irradiation subject and which is also positionable in, or slidable through a slot in, a dose reader which includes a reflection or transmission densitometer.

[0008] U.S. Patent No. 7,445,880 describes the use of a unique polyacetylene lithium salt in the form of particles having a specific dimension which salt undergoes a change of color or color density as a function of cumulative exposure to a source of radiation and to the use of said salts asDocket No.: 4476PCTa media for accurate and high-resolution image recording and visual display. U.S. Patent No.8,212,203 relates to a method and associated apparatus which compensates for variations in amounts of a radiation sensitive material in a radiation dosimetry film.

[0009] The radiation sensitive material of a radiation dosimeter may be comprised of microcrystalline pentacosadiynoic acid (PCD A) dispersed in a polymer matrix. Subjecting monomeric PCDA crystals, or related compounds such as metal salts of PCD A, to ionizing radiation results in progressive polymerization, the degree of polymerization increasing with radiation dose. The amount of polymerization (and hence, the radiation dose) can be determined by measuring either the optical density or the spectral absorption of the exposed dosimeter. However, it has been found that these parameters also vary with both the temperature of the device when measured as well as the thickness of PCDA dispersion and the moisture content of the polymer matrix. Maximum accuracy of dose measurement must account for the temperature and thickness and moisture effects.

[0010] Radiation dosimetry film provides a means for measuring radiation exposure at a point, but its principal utility is in obtaining a two-dimensional map of radiation exposure, i.e. radiation exposure at multiple points in a two-dimensional array. Atypical user may measure an 8"* 10" size film in one, or more, color channels at a spatial resolution of 75 dpi, generating a map of radiation doses at 450,000 points. Of course, other resolutions can be used to generate the radiation exposure map.

[0011] In practice, there is a problem presented by the measurement of the radiation sensitive film at a multiplicity of points. The problem is the availability and cost of means to make the measurements. Measurements of optical absorbance of the active component of a film (e.g. PCDA or the lithium salt of PCDA, LiPCDA) at the primary absorbance peak and other components at predetermined wavelengths would require the use of a scanning spectrophotometer. Such equipment is not readily available and would be of high cost. Furthermore, the speed of operation would be slow because of the low intensity of the light source at the specific wavelengths where measurement is required.

[0012] A possible solution to the problem is to employ a film or document scanner to collect measurements of the film. The advantage of such means is that these scanners are widely available, they are of relatively low cost (often <$1000), they scan at high spatial resolution (the range ofDocket No.: 4476PCTresolution is from 120 dpi to 6400 dots per inch), they are rapid in operation (8"x 10" scan at 75 dpi resolution in <30 seconds), and they are adapted to measure color.

[0013] The triple-channel dosimetry system provides an accurate, reliable, single-use and easy-to-use dosimeter and reader intended for use in measuring dose on-phantom or on-patient in medical dosimetry applications, such as radiotherapy and diagnostic radiology. When used to measure patient dose, the system is used to provide a secondary verification of radiation dose as a means of Quality Control for the primary dose calculation method. The output of the Point Dose system is not used to adjust the dose to the patient

[0014] A triple-channel dosimetry system of present application has advantages, including: precise and accurate dose values + / -5% accuracy levels, high spatial resolution, allowing for detailed dose measurements in two dimensions with a portable film scanner device, relative ease of handling and analyzing, making it convenient for dose measurements, and film-based dosimeters also have the potential for real-time applications, for point / surface-based in vivo dosimetry.

[0015] A film scanner is not like a spectrophotometer. It does not measure absorbance at specific wavelengths, but rather measures over a band of wavelengths. The band of wavelengths over which a specific model of scanner operates is defined by a combination of factors including the spectral output of a light source, the spectral absorbance of optical filters in the light path and the spectral response of the detector. A scanner adapted for color measurement typically will assess light absorbance integrated over three bands of wavelengths defining red, green and blue portions of the visible spectrum. The contribution of light absorbance at each wavelength to the total signal within a color band varies wavelength by wavelength. The weight at each wavelength is not user-defined, but rather depends on the aforesaid factors of spectral output of a light source, the spectral absorbance of optical filters in the light path and the spectral response of the detector.

[0016] Further, triple-channel dosimetry using reflective scanning is a specialized method for analyzing Gafchromic films by utilizing the reflective mode of a flatbed optical scanner to improve flexibility in scanning protocols reducing calibration uncertainty, better reflective scanning integration, and for dynamic calibration user interface.Docket No.: 4476PCTSUMMARY OF THE INVENTION

[0017] One of the aspects of the present disclosure relates to a triple-channel dosimetry system comprising: i) a point dose measurement device comprising a fdm assembly having at least one radiation sensitive film; ii) a template comprising at least one slot to place the radiation sensitive film; iii) a flatbed optical scanner to capture radiation data of the radiation sensitive film through reflective scanning; and iv) dedicated software module enabling in-vivo dosimetry measurements.

[0018] Another aspect of the present disclosure relates to a method for measuring a radiation dose, comprising the steps of: i) exposing point dose measurement device to a pattern of radiation to form region of interest, ii) exposing areas of point dose measurement device of step i) to a plurality of predetermined doses of the radiation to form calibration curves through an autocalibration process at specified intervals, iii) scanning the exposed point dose measurement device of step ii) together with an unexposed / reference point dose measurement device at a single time to produce a digital image, iv) measuring areas of the digital image of step iii) corresponding to the unexposed point dose measurement device and the calibration point dose measurement device (s) exposed to different predetermined dose ranges through a reflection mode scanner, and v) mapping the measured responses of step iv) to the areas of predetermined doses and correlating the scanner response to dose values, and vi) to provide the response values of radiation.

[0019] One more aspect of the present application relates to an user interface process for radiation dose calibration, comprising: i) capturing high and low doses of a point dose measurement device; ii) performing automatic workflow by generating auto- region of interest (ROI); iii) defining parameters to scan automatically; iv) performing automatic selection of fitting functions for low and high dose measurements and optimizing dosimetry results; and v)providing a set of time-resolved calibration curves.

[0020] Another aspect of the present application relates to an user interface process for radiation dose measurement comprising the steps of: i) placing a point dose measurement device on scan area within the device holder / template of the flatbed optical scanner; ii) pre-reading the data of automatic identification and data capture (AIDC) of a point dose measurement device; iii) validating the serial number, lot number & expiry date with the data of automatic identification and data capture (AIDC); iv) submitting input parameters by an user; v) automatically placingDocket No.: 4476PCTa ROI (region of interest) on a point dose measurement device; vi) capturing the data of reflection; vii) selecting corresponding calibration curve; viii) correlating scanner response to dose; ix) storing the correlated dose radiation data; and x) reporting the dose radiation.Docket No.: 4476PCTBRIEF DESCRIPTION OF THE FIGURES

[0021] The invention will be better understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawing are not to scale. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity. The following figures are included in the drawing.

[0022] Fig. 1 : Time of Exposure, Dose range selection, calibration curve selection and correction factor input provisions

[0023] Fig. 2: Calibration Preview Screen

[0024] Fig. 3: Calibration Preview Screen of point dose device

[0025] Fig.4: Calibration workflow

[0026] Fig.5: Measurement workflow

[0027] Fig 6: An example of the calibration set with low / high calibration curves

[0028] Fig 7: In-vivo measurement reading interface showing user

[0029] Fig. 8: Pass / Fail Scanner Report

[0030] Fig.9: Already been used Device Warning

[0031] Fig.10: Too soon for Selected Calibration

[0032] Fig. 11 : Late for Selected Calibration

[0033] Fig.12: No Reference Device FoundDocket No.: 4476PCTDETAILED DESCRIPTION OF THE INVENTION

[0034] Before explaining at least one aspect of the disclosed and / or claimed inventive concept(s) in detail, it is to be understood that the disclosed and / or claimed inventive concept(s) is not limited in its application to the details of construction and the arrangement of the components or steps or methodologies set forth in the following description or illustrated in the drawings. The disclosed and / or claimed inventive concept(s) is capable of other aspects or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

[0035] As utilized in accordance with the disclosure, the following terms, unless otherwise indicated, shall be understood to have the following meanings.

[0036] Unless otherwise defined herein, technical terms used in connection with the disclosed and / or claimed inventive concept(s) shall have the meanings that are commonly understood by those of ordinary skill in the art. Further, unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular.

[0037] The singular forms “a”, “an”, and “the” include plural forms unless the context clearly dictates otherwise specified or clearly implied to the contrary by the context in which the reference is made. The term “Comprising” and “Comprises of’ includes the more restrictive claims such as “Consisting essentially of’ and “Consisting of’.

[0038] For purposes of the following detailed description, other than in any operating examples, or where otherwise indicated, numbers that express, for example, quantities of ingredients used in the specification and claims are to be understood as being modified in all instances by the term "about". The numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties to be obtained in carrying out the invention.

[0039] All percentages, parts, proportions and ratios as used herein, are by weight of the total composition, unless otherwise specified. All such weights as they pertain to listed ingredients are based on the active level and, therefore; do not include solvents or by-products that may be included in commercially available materials, unless otherwise specified.Docket No.: 4476PCT

[0040] All publications, articles, papers, patents, patent publications, and other references cited herein are hereby incorporated herein in their entirety for all purposes to the extent consistent with the disclosure herein.

[0041] The use of the term “at least one” will be understood to include one as well as any quantity more than one, including but not limited to, 1, 2, 3, 4, 5, 10, 15, 20, 30, 40, 50, 100, etc. The term “at least one” may extend up to 100 or 1000 or more depending on the term to which it is attached.

[0042] In addition, the quantities of 100 / 1000 are not to be considered limiting as lower or higher limits may also produce satisfactory results.

[0043] As used herein, the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”) or “containing” (and any form of containing, such as “contains” and “contain”) are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.

[0044] The term “each independently selected from the group consisting of’ means when a group appears more than once in a structure, that group may be selected independently each time it appears.

[0045] The term “polymer” refers to a compound comprising repeating structural units (monomers) connected by covalent chemical bonds. Polymers may be further derivatized, crosslinked, grafted or end-capped. Non -limiting examples of polymers include polymers, terpolymers, tetrapolymers, quaternary polymers, and homologues.

[0046] The term “radiochromic film” as used herein generally refers to fdm that changes color and produces a visible image when exposed to ionizing radiation, but experiences insignificant change from exposure to visible light or other forms of non-ionizing radiation.

[0047] The term “ionizing radiation” as used herein generally refers to radiation with a level of energy that is high enough to cause atoms to lose electrons and become charged or ionized. Ionizing radiation may be in the form of a high energy particles, like an alpha or beta particles, or in the form of electromagnetic waves, like gamma rays or x-rays. High energy particles and electromagnetic waves are released from the nuclei of radioactive atoms that are decaying or may be created by causing accelerated electrons to strike a metal target.Docket No.: 4476PCT

[0048] The term “Dose volatility” is standard deviation of the dose.

[0049] The term “scanner” as used herein is generally employed to refer to a device that can be used to optically scan a multidimensional film and output a multidimensional image relating the optical transmittance or reflectance of the film at an array of locations.

[0050] The term “flatbed optical scanner” is used to describe a scanner for scanning film in a two-dimensional plane. The flatbed optical scanner includes a RGB color scanner.

[0051] The term “automatic identification and data capture (AIDC) scanner” is used to describe a scanner in which the sensor device is an array of charge coupled elements. The device used to scan and detect information encoded in bar codes, Radio Frequency Identification (RFID), optical character recognition (OCR),QR Codes. As used herein, CCD is an example of an AIDC.The terms “RGB scanner” and “RGB color scanner” as used herein generally refer to scanners that produce an image composed of response values in color channels comprising the red, green and blue portions of the visible color spectrum. The term “color channel” as used herein is generally employed to refer to one of the output response bands of an optical color scanner. The term “component color channel” as used herein is generally used to refer to one of the color channels within an image composed of a multiplicity of color channels. The terms “response value” and “scanner response value” as used herein generally refer to a measure of the light intensity transmitted or reflected at a location on a fdm as determined by an optical scanner. The term “pixel value” as used herein generally refers to the response value for an individual pixel within a digital image. The term “marker dye” as used herein generally refers to a colored substance impervious to exposure by ionizing radiation that is incorporated in the active layer of a radiation sensitive film to provide a reference response value in at least one color channel proportional to the thickness of the active layer.

[0052] The term “reference channel” as used herein refers to the color channel in which the marker dye provides the greatest response.

[0053] The term “triple channel correction” as used herein refers to the correction method in which the responses of three color channels are used to correct the response of a radiation sensitive film for differences in the thickness of the radiationDocket No.: 4476PCT

[0054] The term ‘display device’ is a smart phone, a smart pad, a tablet PC, a kiosk, a monitor, a wall display, a music player, a desktop computer, a smart table, a TV, a laptop computer or other device capable of displaying information digitally.

[0055] In the present disclosure the term “radiation” refers to ionizing or non-ionizing radiation that carries enough energy to liberate electrons from atoms or molecules, thereby ionizing them. Radiation may include, but is not limited to, X-rays, y rays, electrons, protons, neutrons, ions, or any combination thereof. Non-ionizing radiation refers to any type of electromagnetic radiation that does not carry enough energy per quantum (photon energy) to ionize atoms or molecules, that is, to completely remove an electron from an atom or molecule. Non-ionizing radiation may include, but is not limited to, ultraviolet (UV), visible, or infrared (IR) light, or any combination thereof.

[0056] The term “ionizing radiation” as used herein generally refers to radiation with a level of energy that is high enough to cause atoms to lose electrons and become charged or ionized. Ionizing radiation may be in the form of high energy particles, like alpha and beta particles, protons and neutrons, or in the form of electromagnetic waves, like gamma rays or X-rays. High energy particles and electromagnetic waves are released from the nuclei of radioactive atoms that are decaying or may be created by causing accelerated electrons to strike a metal target.

[0057] As used herein, the term "insect sterilization” is a biological control process. In this process, for example, a large number of male insects are sterilized by a radiation process. These insects are then released in the wild and compete to fertilize wild female insects. Because these sterile insects are competing with fertile insects, the total insect population is more controlled and potentially reduced.

[0058] As used here, the term "phytosanitary application" refers to a process that is intended to protect humans against harmful pests and diseases that can be found on plants.

[0059] As used herein, the term "medical device sterilization" refers to medical device or component to withstand sterilization and functional characteristics and mechanical properties without significant loss of capacity. Sterilizing comprises sterilizing process during exposure to radiation such as gamma ray and / or X-ray can withstand radiation sterilization and functional characteristics without substantial loss of medical device or parts thereof can be referred to as "radiation". Examples of high-energy photon sterilizing process comprises exposing the medicalDocket No.: 4476PCTdevice to self-isotope source such as cobalt 60 emitted by the isotope source throughout the medical device generating ionized or electronic damage (those fracturing). Sterilization may also comprise ethylene oxide sterilization, electronic beam sterilization, autoclaving (steam sterilization), plasma sterilization, dry heat sterilization, chemical sterilization and X-ray beam sterilization.

[0060] The term “algorithm or user interface” refers to a Graphical User Interface (GUI) that allows users to interact with software and hardware systems easily. It typically includes windows for displaying code, command input, breakpoints, variables, and other relevant information, enhancing user experience and efficiency.

[0061] The term “auto-ROI (region of interest) generation” refers to a specific scanned area of the film surface for dose reading.

[0062] The term “reflective scanning” refers to an option to choose from flatbed optical scanner depending on the type of film / device config where scanner light illuminates the film / device and a sensor detects the light reflected from device surface.The term “radiation sensitive film or radiochromic film” refers to a radiochromic dosimetry film comprises a substrate covering with an active layer, the film is designed for the quantitative measurement of absorbed dose of high-energy photons. Key technical features include: (i) dynamic dose range: 10 Gy to 50,000 Gy, (ii) develops in real time without post-exposure treatment; (iii) energy-dependence: minimal response difference from 100 keV into the MV range; (iv) near tissue equivalent; (v) high spatial resolution - can resolve features to 5 ppm, or less; (vi) active coating exposed for detection of low energy photon and electron; (vii) proprietary new technology incorporating a marker dye in the active coating: enables nonuniformity correction by using triple-channel dosimetry and decreases UV light sensitivity; and (viii) stable at temperatures up to 60 °C.

[0063] Gafchromic™ RADIOCHROMIC is useful as an active layer for the radiation dosage indicator of the present disclosure. Gafchromic™ RADIOCHROMIC has an asymmetrical cross section. Measurements indicate that the response of scanner or densitometer may be dependent on which side of the film is facing the light source. It is advised that active layer be consistentlyDocket No.: 4476PCTmeasured with the same side of the film facing the light source regardless of whether landscape or portrait orientation is used. The term "about" refers to a range of values + 10% of a specified value. For example, the phrase "about 200" includes ± 10% of 200, or from 180 to 220. All percentages, ratio, and proportions used herein are based on a weight basis unless other specified. In accordance with one embodiment of the present invention, the present invention relates to a triple-channel dosimetry system comprising:! ) a point dose measurement device comprising a film assembly having at least one radiation-sensitive film; (ii) a template comprising at least one slot configured to position the radiation sensitive film; (iii) a flatbed optical scanner capable of reflective scanning and capturing optical density data in at least three colors; and (iii) dedicated software configured to process the scanned film data, to perform in-vivo dosimetry measurements. In accordance with one embodiment of the present invention, the radiation sensitive film is a composition comprising a microcrystalline dispersion of a substantially crystalline image receptive polyacetylenic compound.

[0064] The radiation sensitive film of a radiation dosimeter may be comprised of microcrystalline pentacosadiynoic acid (PCDA), or other diacetylenic compounds and other compounds that exhibit dose responsive chemical changes, dispersed in a polymer matrix. Subjecting monomeric PCDA crystals, or related compounds such at the metal salts of PCDA, to ionizing radiation results in progressive polymerization, the degree of polymerization increasing with radiation dose. The amount of polymerization (and hence, the radiation dose) can be determined by measuring either the optical density or the spectral absorption of the exposed dosimeter. However, it has been found that these parameters also vary with both the temperature of the device when measured as well as the thickness of PCDA dispersion and the moisture content of the polymer matrix. Maximum accuracy of dose measurement must account for the temperature and thickness and moisture effects.

[0065] In accordance with one embodiment of the present invention, the polyacetylenic compound has the structure: A-(CH2)n — C=C — C=C — (CH2)m — B, wherein m and n are both independently an integer from 6 to 14 and A and B are independent from one another and are selected from the group consisting of methyl, carboxyl, hydroxy, amido, lower alkyl substituted amido, aliphatic or aromatic carboxylate ester group having up to 10 carbon atoms, mono- or divalent carboxylate metal salt group, halo, carbamyl, lower alkyl substituted carbamyl or tosyl, triyn or tetrayne products of the above polyacetylenes having from 20 to 60 carbon atoms and aDocket No.: 4476PCTconjugated structure, and combinations thereof, active component comprises a substantially crystalline image receptive polyacetylenic compound having the structure:A-(CH2)n— C=C— C=C— (CH2)m— B

[0066] wherein m and n are both independently an integer from 6 to 14 and A and B are independent from one another and are selected from the group consisting of methyl, carboxyl, hydroxy, amido, lower alkyl substituted amido, aliphatic or aromatic carboxylate ester group having up to 10 carbon atoms, mono- or di-valent carboxylate metal salt group, halo, carbamyl, lower alkyl substituted carbamyl or tosyl, triyn or tetrayne products of the above polyacetylenes having from 20 to 60 carbon atoms and a conjugated structure, and combinations thereof.

[0067] In accordance with one embodiment of the present invention, the active component is filamentary particles of lithium salt of a conjugated polymerizable polyacetylene having at least one terminal carboxylic acid or carboxylate group and a mixture of said polyacetylenes; said filamentary particles having a length to width ratio of at least 5:1; said filamentary particles having no platelet particles mixed therewith.

[0068] In accordance with one embodiment of the present invention, the polyacetylenic compound is selected from the group consisting of pentacosa-10,12-diynoic acid; tricosa-10,12-diynoic acid, heneicosa-10,12-diynoic acid and combinations thereof.

[0069] In accordance with one embodiment of the present invention, the polyacetylenic compound is Gafchromic films. Examples including but not limited to Gafchromic™ EBT4 and EBT-XD.

[0070] In accordance with one embodiment of the present invention, the radiation sensitive film is formed by a single pass coating on the mounting layer.

[0071] In accordance with one embodiment of the present invention, the radiation sensitive film is coated on the mounting layer in a form dispersion.

[0072] In accordance with one more embodiment of the present invention, the radiation sensitive film is coated on the mounting layer in a coatable fluid dispersions.

[0073] In accordance with one embodiment of the present invention, the radiation sensitive film is having a thickness ranging from about 5 pm to about 100 pm.Docket No.: 4476PCT

[0074] In accordance with one more embodiment of the present invention, the active layer is having a thickness ranging from about 5 pm to about 10 pm, from about 11 pm to about 15 pm, from about 16 pm to about 20 pm, from about 21 pm to about 25 pm, from about 26 pm to about 30 pm, from about 31 pm to about 35 pm, from about 36 pm to about 40 pm, from about 41 pm to about 45 pm, from about 46 pm to about 50 pm, from about 51 pm to about 55 pm, from about 56 pm to about 60 pm, from about 61 pm to about 65 pm, from about 66 pm to about 70 pm, from about 71 pm to about 75 pm, from about 76 pm to about 80 pm, from about 81 pm to about 85 pm, from about 86 pm to about 90 pm, from about 91 pm to about 95 pm, from about 96 pm to about 100 pm.

[0075] In accordance with one embodiment of the present invention, the polyacetylenic compound which selectively absorbs incident low energy photon radiation in an amount from about 0.1 to 50.0% by weight of micro-crystalline dispersion of active layer.

[0076] In accordance with one embodiment of the present invention, the flatbed optical scanner having a resolution range from 120 dpi to 6400 dots per inch (dpi).

[0077] In accordance with one more embodiment of the present invention, the flatbed optical scanner has a light source of a light emitting diode (LED) or a fluorescent source.

[0078] In accordance with another embodiment of the present invention, the light form is white, yellow or red color.

[0079] In accordance with one more embodiment of the present invention, the triple-channel dosimetry system is having a dynamic dose range from 3cGy to 600cGy.

[0080] In accordance with another embodiment of the present invention, the template has a shape selected from the group consisting of circular, rectangular, triangular, semi-circular, square and combinations thereof.

[0081] Another embodiment of the present disclosure relates to a method for measuring a radiation dose, comprising the steps of: i) exposing point dose measurement device to a pattern of radiation to form region of interest, ii) exposing areas of point dose measurement device of step i) to a plurality of predetermined doses of the radiation to form calibration curves through an autocalibration process at specified intervals, iii) scanning the exposed point dose measurement device of step ii) together with an unexposed / reference point dose measurement device at a singleDocket No.: 4476PCTtime to produce a digital image, iv) measuring areas of the digital image of step iii) corresponding to the unexposed point dose measurement device and the calibration point dose measurement device (s) exposed to different predetermined dose ranges through a reflection mode scanner, and v) mapping the measured responses of step iv) to the areas of predetermined doses and correlating the scanner response to dose values, and vi) to provide the response values of radiation.

[0082] One more embodiment of the present application relates to an user interface process for radiation dose calibration, comprising: i) capturing high and low doses of a point dose measurement device; ii) performing automatic workflow by generating auto- region of interest (ROI); iii) defining parameters to scan automatically; iv) performing automatic selection of fitting functions for low and high dose measurements and optimizing dosimetry results; and v)providing a set of time-resolved calibration curves.

[0083] The automated workflow incorporates auto-ROI (region of interest) generation and autocalibration scanning at user-specified intervals (e.g., 5-min intervals for the first hour, followed by 15-min intervals up to 24 h) to build a time-resolved set of triple-channel calibration curves to capture the optical density growth post-irradiation. The Time of Exposure, Dose range selection, calibration curve selection and correction factor are input provisions as show in Fig. 1.

[0084] The scanner will turn-on and pre- read the devices and ensure all devices are from the same lot and have not expired and display in a table listing the serial number relative to each of the nine slots on the device holder. If the serial numbers are not legible by the software or if the lot numbers do not match each other, the program will halt, and a message will display with the discrepancy. If there are no error messages the software will automatically place the ROI (region of interest) on each device eliminating both user and scanner variability effects. See Fig. 2 & Fig.3.

[0085] Reflective Scanning Integration: Incorporation of reflective scanning techniques to improve data acquisition in systems with diverse material reflectivity, reducing signal noise and increasing reliability across varying sample conditions. Triple-channel dosimetry with reflective scanning mitigates post irradiation darkening errors utilizing information from all three-color channels (red, green, and blue).

[0086] Dynamic Calibration Algorithm: A near real-time calibration is implemented to compensate variations in scanner sensitivity and environmental conditions, ensuring consistentDocket No.: 4476PCTand reproducible dosimetry results. The system employs separate coordinate maps indexed to different scanner models, thereby reducing scanner-dependent variability and improving reproducibility.

[0087] Streamlined calibration & In-vivo measurement workflow with advanced algorithms

[0088] The calibration workflow was described in Fig.4.

[0089] The measurement workflow was described in Fig.5.

[0090] Automatic selection of fitting functions for low & high dose measurements optimizing dosimetry results (built into the user interface). An example, as shown in Fig.6 of the calibration set with low / high calibration curves at each time point with a slider bar to view all calibration curves in the set. System allows for accurate dosimetry over a dynamic range of doses, typically from 10 cGy to 400 CGy.

[0091] In-vivo measurement reading interface showing user selection of calibration curve and user input of irradiation time and output was shown in Fig. 7.

[0092] Storing OD image (OD readings shortly after irradiation for treatment plan device) for comprehensive diagnosis and user interface output along with radio sensitive device was shown in Table 1. The software incorporates alerts / safeguards that automatically detect and guide users to correct common sources of error in film dosimetry.

[0093] Table 1. Storing OD image for comprehensive diagnosis

[0094] Daily scanner check:Docket No.: 4476PCT

[0095] Once the scanner completes the 20 scans a “Scanner Report” will appear that will display the triple channel readings giving an overall Pass or Fail condition. If the system fails, this means the percent values for any of the color channels have exceeded a 3% error margin and the scanner needs to be examined for failure issues and repeat the procedure. See Figure 8.

[0096] Warning and Messages:

[0097] The Pnt-Dos™ device module has several messages and warnings to alert the user. Pnt-Dos device warning that the device has already been used and read at least one time. By clicking on OK the user has been warned and can either use another device or continue. See Fig 9.

[0098] Time since Exposure is less than the time of the first calibration. If a Pnt-Dos™ device reading would commence before the time the calibration reading was initiated this warning will appear. The user can continue or decide to wait until the time of the first reading on the calibration. If the user decided to continue the program will select the first calibration curve. See Fig.10.

[0099] Time since Exposure is greater than the time of the first calibration. If a Pnt-Dos™ device reading would commence after the time the calibration reading was finished this warning will appear. The user can continue or decide to wait until the time of the first reading on the calibration. If the user decides to continue, the program will select the last calibration curve. See Fig. 11.

[0100] No reference Device Found warning. If the user does not put a reference device into the device holder for the Pnt-Dos™ reader measurement, the program will give a warning to proceed or start over, where the user can add the reference device. If the user decides to continue, no correction will be made to the displayed dose on the report. See Fig.12.

[0101] Another embodiment of the present application relates to an user interface process for radiation dose measurement comprising the steps of: i) placing a point dose measurement device on scan area within the device holder / template of the flatbed optical scanner; ii) pre-reading the data of automatic identification and data capture (AIDC) of a point dose measurement device; iii) validating the serial number, lot number & expiry date with the data of automatic identification and data capture (AIDC); iv) submitting input parameters by an user; v) automatically placing a ROI (region of interest) on a point dose measurement device; vi) capturing the data of reflection; vii) selecting corresponding calibration curve; viii) correlating scanner response to dose; ix) storing the correlated dose radiation data; and x) reporting the dose radiation.Docket No.: 4476PCT

[0102] The user interface process for radiation dose calibration, wherein the parameters are selected from the group consisting of time of exposure, dose range selection, calibration curve selection and correction factor.

[0103] The user interface process for radiation dose calibration, wherein the calibration is near real-time calibration with a dynamic interface.

[0104] The user interface process for radiation dose calibration , wherein the dose range is dynamic with range from 10 cGy to 400 CGy.

[0105] While the compositions and methods of the disclosed and / or claimed inventive concept(s) have been described in terms of particular aspects, it will be apparent to those of ordinary skill in the art that variations may be applied to the compositions and / or methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the disclosed and / or claimed inventive concept(s). All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the disclosed! and / or claimed inventive concept(s).Embodiment A: A triple-channel dosimetry system comprising:i. a point dose measurement device comprising a film assembly having at least one radiation sensitive film;ii. a template comprising at least one slot to place the radiation sensitive film; iii. a flatbed optical scanner to capture radiation data of the radiation sensitive film through reflective scanning; andiv. dedicated software module enabling in-vivo dosimetry measurements.Embodiment B: The triple-channel dosimetry system according to embodiment A, wherein the radiation sensitive film comprises a microcrystalline dispersion of a substantially crystalline image receptive polyacetylenic compound.Docket No.: 4476PCTEmbodiment C: A triple-channel dosimetry system according to embodiment B, wherein the polyacetylenic compound has the structure:A-(CH2)n— C=C— C=C— (CH2)m— Bwherein m and n are both independently an integer from 6 to 14 and A and B are independent from one another and are selected from the group consisting of methyl, carboxyl, hydroxy, amido, lower alkyl substituted amido, aliphatic or aromatic carboxylate ester group having up to 10 carbon atoms, mono- or di-valent carboxylate metal salt group, halo, carbamyl, lower alkyl substituted carbamyl or tosyl, triyn or tetrayne products of the above polyacetylenes having from 20 to 60 carbon atoms and a conjugated structure, and combinations thereof.Embodiment D: The triple-channel dosimetry system according to embodiment C, wherein the polyacetylenic compound is selected from the group consisting of pentacosa-10,12-diynoic acid; tricosa-10,12-diynoic acid, heneicosa-10,12-diynoic acid and combinations thereof.Embodiment E: The triple-channel dosimetry system according to embodiment A, wherein the fdm assembly is having automatic identification and data capture (AIDC) indicia on top layer of the film assembly.Embodiment F: The triple-channel dosimetry system according to embodiment A, wherein the scanner is a flatbed optical scanner.Embodiment G: The triple-channel dosimetry system according to embodiment F, wherein the flatbed optical scanner having a resolution range from 120 dpi to 6400 dots per inch (dpi).Embodiment H: The triple-channel dosimetry system according to embodiment F, wherein the flatbed optical scanner has a light source of a light emitting diode (LED) or a fluorescent source.Docket No.: 4476PCTEmbodiment I: The triple-channel dosimetry system according to embodiment H, wherein the light form is white, yellow or red color.Embodiment J: The triple-channel dosimetry system according to embodiment A, wherein the triple-channel dosimetry system has a dynamic dose range from 3cGy to 600cGy.Embodiment K: The triple-channel dosimetry system according to embodiment, wherein the template has a shape selected from the group consisting of circular, rectangular, triangular, semicircular, square and combinations thereof.Embodiment L: A method for measuring a radiation dose, comprising the steps of:i) exposing point dose measurement device to a pattern of radiation to form region of interest, ii) exposing areas of point dose measurement device of step i) to a plurality of predetermined doses of the radiation to form calibration curves through an autocalibration process at specified intervals,iii) scanning the exposed point dose measurement device of step ii) together with an unexposed / reference point dose measurement device at a single time to produce a digital image, iv) measuring areas of the digital image of step iii) corresponding to the unexposed point dose measurement device and the calibration point dose measurement device (s) exposed to different predetermined dose ranges through a reflection mode scanner,v) mapping the measured responses of step iv) to the areas of predetermined doses and correlating the scanner response to dose values, andvi) to provide the response values of radiation.Embodiment M: A user interface process for radiation dose calibration, comprising:i) capturing high and low doses of a point dose measurement device;ii) performing automatic workflow by generating auto- region of interest (ROI);Docket No.: 4476PCTiii) defining parameters to scan automatically;iv) performing automatic selection of fitting functions for low and high dose measurements and optimizing dosimetry results; andv) providing a set of time-resolved calibration curves.Embodiment N: The user interface process for radiation dose calibration according to embodiment M, wherein the parameters are selected from the group consisting of time of exposure, dose range selection, calibration curve selection and correction factor.Embodiment O: The user interface process for radiation dose calibration according to embodiment M, wherein the calibration is near real-time calibration with a dynamic interface.Embodiment P: The user interface process for radiation dose calibration according to embodiment M, wherein the dose range is dynamic with range from 10 cGy to 400 CGy.Embodiment Q: A user interface process for radiation dose measurement comprising the steps of: i) placing a point dose measurement device on scan area within the device holder / template of theflatbed optical scanner;ii) pre-reading the data of automatic identification and data capture (AIDC) of a point dose measurement device;iii) validating the serial number, lot number & expiry date with the data of automatic identification and data capture (AIDC);iv) submitting input parameters by an user;v) automatically placing a ROI (region of interest) on a point dose measurement device; vi) capturing the data of reflection;vii) selecting corresponding calibration curve;viii) correlating scanner response to dose;Docket No.: 4476PCTix) storing the correlated dose radiation data; andx) reporting the dose radiation.Embodiment R: The user interface for a process of measuring a radiation dose according to embodiment Q, where in the AIDC indicia is selected from the group consisting of bar codes, Radio Frequency Identification (RFID), optical character recognition (OCR), QR Codes and combinations thereof.Embodiment S: The user interface for a process of measuring a radiation dose according to embodiment Q, wherein point dose measurement device is subjected to a reflection mode during the process of measurement.Embodiment T: The user interface process for radiation dose measurement according to embodiment Q, storing the image data in red-green-blue (RGB) tagged image file format (TIFF).Embodiment U: The user interface process for radiation dose measurement according to embodiment Q, wherein the parameter is selected from the group consisting of time of exposure, dose range selection, calibration curve selection and correction factor.

Claims

Docket No.: 4476PCTWe Claim:

1. A triple-channel dosimetry system comprising:i) a point dose measurement device comprising a fdm assembly having at least one radiation-sensitive fdm;ii) a template comprising at least one slot configured to position the radiation sensitive film;iii) a flatbed optical scanner capable of reflective scanning and capturing optical density data in at least three colors; andiv) dedicated software configured to process the scanned film data to perform in-vivo dosimetry measurements.

2. A triple-channel dosimetry system according to claim 1 wherein the flatbed optical scanner has a light source of a light emitting diode (LED) or a fluorescent source and wherein the light form in three colors is white, yellow or red color.

3. The triple-channel dosimetry system according to claim 1, wherein the radiation sensitive film comprises a microcrystalline dispersion of a substantially crystalline, image-receptive polyacetylenic compound.

4. The triple-channel dosimetry system according to claim 3, wherein the polyacetylenic compound has the structure:A-(CH2)n— C=C— C=C— (CH2)m— Bwherein m and n are each independently an integer from 6 to 14 and A and B are independently selected from the group consisting of methyl, carboxyl, hydroxy, amido, lower alkyl substituted amido, aliphatic or aromatic carboxylate ester group having up to 10 carbon atoms, mono- or divalent carboxylate metal salt group, halo, carbamyl, lower alkyl substituted carbamyl or tosyl, triynDocket No.: 4476PCTor tetrayne products of the above polyacetylenes having from 20 to 60 carbon atoms and a conjugated structure, and combinations thereof.

5. The triple-channel dosimetry system according to claim 3, wherein the polyacetylenic compound is selected from the group consisting of pentacosa-10,12-diynoic acid; tricosa-10,12-diynoic acid, heneicosa-10,12-diynoic acid and combinations thereof.

6. The triple-channel dosimetry system according to claim 1 , wherein the film assembly includes automatic identification and data capture (AIDC) indicia on a top layer of the film assembly and wherein the scanner is a flatbed optical scanner.

7. The triple-channel dosimetry system according to claim 5, wherein the flatbed optical scanner has a resolution range from 120 dpi to 6400 dots per inch (dpi).

8. The triple-channel dosimetry system according to claim 1, wherein the system has a dynamic dose range from 3cGy to 600cGy and wherein the template has a shape selected from the group consisting of circular, rectangular, triangular, semi-circular, square and combinations thereof.

9. A method for measuring a radiation dose, comprising the steps of:i) exposing point dose measurement device to a pattern of radiation to form region of interest;ii) exposing areas of the point-dose measurement device of step i) to a plurality of predetermined radiation doses to generate calibration curves through an autocalibration process at specified intervals;iii) scanning the exposed point-dose measurement device of step ii) together with an unexposed reference point-dose measurement device at a single time to produce a digital image;Docket No.: 4476PCTiv) measuring areas of the digital image of step iii) corresponding to the unexposed reference point-dose measurement device and the calibration point-dose measurement device(s) exposed to different predetermined dose ranges using a reflection-mode scanner;v) mapping the measured responses of step iv) to the areas of predetermined doses and correlating the scanner response to dose values; andvi) providing the resulting radiation dose response values.

10. A user-interface process for radiation-dose calibration, comprising:i) capturing high-dose and low-dose measurements of a point-dose measurement device;ii) executing an automated workflow by generating an automatic region of interest (ROI);iii) defining parameters for automated scanning;iv) automatically selecting fitting functions for low-dose and high-dose measurements and optimizing the resulting dosimetry outputs; andv) providing a set of time-resolved calibration curves.

11. The user interface process for radiation dose calibration of claim 10, wherein the calibration is performed in near real time using a dynamic interface; wherein the dose range is adjustable from 10 cGy to 400 cGy; and wherein the parameters are selected from the group consisting of exposure time, dose range selection, calibration curve selection, and correction factor, -interface process for radiation-dose calibration of claim 10, wherein the-range selection, calibration-curve selection, and correction factor.Docket No.: 4476PCT12. A user interface process for radiation dose measurement comprising the steps of:i) placing a point dose measurement device on scan area within the device holder / template of the optical flatbed optical scanner;ii) pre-reading the data of automatic identification and data capture (AIDC) of a point dose measurement device;iii) validating the serial number, lot number & expiry date with the data of automatic identification and data capture;iv) submitting input parameters by an user;v) automatically placing a region of interest (ROI) on a point dose measurement device;vi) capturing the data of reflection;vii) selecting corresponding calibration curve;viii) correlating scanner response to dose;ix) storing the correlated dose radiation data; andx) reporting the dose radiation.

13. The user interface for a process of measuring a radiation dose according to claim 12, where in the AIDC indicia is selected from the group consisting of bar codes, Radio Frequency Identification (RFID), optical character recognition (OCR), QR Codes and combinations thereof.

14. The user interface for a process of measuring a radiation dose according to claim 12, wherein the point-dose measurement device is subjected to reflection-mode scanning during the measurement process, and wherein the parameter is selected from the group consisting of exposure time, dose-range selection, calibration-curve selection, and correction factor.