# US 12,191,005 B2 · Radiology-based risk assessment for biopsy-based scores > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,191,005 B2 - Document ID: US12191005B2 - Status: Granted - Kind: B2 - Application number: 17/625,105 - Filed: 2020-07-22 - Published: 2022-08-18 - Granted: 2025-01-07 - Earliest claimed: 2019-07-22 - Assignees: Koninklijke Philips N.V. - Applicants: Koninklijke Philips N.V. - Inventors: Reinhold Wimberger-Friedl; Pedro Jorge Da Silva Rodrigues; Vanda Lucia De Carvalho Vittorino De Almeida - Web page: https://patentgrep.com/patent/US12191005B2 ## CPC - G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis - G16H 30/40: for processing medical images, e.g. editing - G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems - G06T 2207/10081: Computed x-ray tomography [CT] - G06T 2207/10088: Magnetic resonance imaging [MRI] - G06T 2207/10104: Positron emission tomography [PET] - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA - G06T: IMAGE DATA PROCESSING OR GENERATION, IN GENERAL ## Abstract A computer-implemented method for determining tumor heterogeneity is provided. Embodiments of the method involve analyzing a radiological image of a tumor to calculate a value indicative of tumor activity at each of a plurality of locations in the tumor; determining whether each calculated value is above a predetermined threshold; and calculating a heterogeneity score for the tumor; wherein the heterogeneity score is calculated based on a volume fraction of the tumor having a value indicative of tumor activity above the predetermined threshold. Also provided are associated systems and computer program products. ## Claims ### Claim 1 A computer-implemented method for determining representativeness of a pathology score to a tumor, the method comprising: analyzing a radiological image of a tumor to calculate a value indicative of tumor activity at each of a plurality of locations in the tumor; determining whether each calculated value at each of the plurality of locations in the tumor is above a predetermined threshold to identify the total number of calculated values above the predetermined threshold; calculating a heterogeneity score for the tumor, wherein the heterogeneity score is calculated based on a volume fraction of the tumor having a value indicative of tumor activity above the predetermined threshold, and thus wherein the heterogeneity score is calculated by dividing the total number of calculated values above the predetermined threshold by a total number of locations in the tumor for which a calculated value was determined; and calculating a probability of a biopsy sample obtained from the tumor having a value of tumor activity above the predetermined threshold, wherein the probability is calculated based on the heterogeneity score and a volume of the biopsy sample. ### Claim 2 (depends on 1) A method according to claim 1, wherein the predetermined threshold of tumor activity is correlated with a clinically relevant threshold of a biological parameter associated with the tumor. ### Claim 3 (depends on 2) A method according to claim 2, wherein the biological parameter comprises an expression level of programmed death-ligand 1 (PD-L1) on tumor cells. ### Claim 4 (depends on 2) A method according to claim 2, wherein the clinically relevant threshold of the biological parameter is a percentage of tumor cells positive for PD-L1 expression (TPS) indicative of suitability for checkpoint inhibition therapy. ### Claim 5 (depends on 1) A method according to claim 1, further comprising comparing the heterogeneity score with a value of the biological parameter determined from a biopsy sample obtained from the tumor; wherein a discordance between the heterogeneity score and the value of the biological parameter is indicative that the value of the biological parameter is unrepresentative of the tumor. ### Claim 6 (depends on 5) A method according to claim 5, wherein if the heterogeneity score indicates a significant volume fraction of the tumor has a value indicative of tumor activity above the predetermined threshold, and the value of the biological parameter is below a clinically relevant threshold, the method further comprises indicating the value of the biological parameter as a potential false negative result. ### Claim 7 (depends on 1) A method according to claim 1, wherein the radiological image is obtained by positron emission tomography (PET), magnetic resonance imaging (MRI), computerized tomography (CT) and/or single-photon emission computed tomography (SPECT), or any combination thereof. ### Claim 8 (depends on 7) A method according to claim 7, wherein the value indicative of tumor activity in the tissue is a standard uptake value (SUV) obtained from PET imaging. ### Claim 9 (depends on 8) A method according to claim 8, wherein the value indicative of tumor activity is obtained by PET imaging using (18-F) fluorodeoxyglucose (FDG). ### Claim 10 (depends on 1) A method according to claim 1, further comprising calculating a contour plot showing regions of the tumor having equal values of tumor activity, wherein a contour in the contour plot corresponds to the predetermined threshold of tumor activity. ### Claim 11 (depends on 1) A method according to claim 1, further comprising indicating to a user a region of the tumor having tumor activity above a predetermined threshold from which a biopsy sample is to be extracted. ### Claim 12 (depends on 1) A method according to claim 1, wherein the volume fraction of the tumor is determined based on a minimum connected volume with a value above the predetermined threshold. ### Claim 13 (depends on 1) A method according to claim 1, wherein the value indicative of tumor activity is indicative of metabolic activity, hypoxia, tumour activation of signalling pathways and/or proliferation in the tumor. ### Claim 14 A system for determining representativeness of a pathology score to a tumor, the system comprising: an interface for receiving a radiological image of a tumor; a memory; and a processor configured to execute instructions stored on the memory to: (a) analyze the radiological image of the tumor to calculate a value indicative of tumor activity at each of a plurality of locations in the tumor; (b) determine whether each calculated value at each of the plurality of locations in the tumor is above a predetermined threshold to identify the total number of calculated values above the predetermined threshold; (c) calculate a heterogeneity score for the tumor, wherein the heterogeneity score is calculated based on a volume fraction of the tumor having a value indicative of tumor activity above the predetermined threshold, and thus wherein the heterogeneity score is calculated by dividing the total number of calculated values above the predetermined threshold by a total number of locations in the tumor for which a calculated value was determined; and (d) calculate a probability of a biopsy sample obtained from the tumor having a value of tumor activity above the predetermined threshold, wherein the probability is calculated based on the heterogeneity score and a volume of the biopsy sample. ### Claim 15 (depends on 1) A computer program product comprising a non-transitory computer readable medium, the computer readable medium having computer readable code embodied therein, the computer readable code being configured such that, on execution by a suitable computer or processor, the computer or processor is caused to perform the method of claim 1.