Comprehensive Assessment of Cancer Theranostics Response

癌症治疗诊断反应的综合评估

• 批准号: 10758983
• 负责人: Paul G. Corn
• 金额: $ 88.16万
• 依托单位: AIQ SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-22 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10758983
• 关键词: Algorithms; Area; Clinical; Clinical Research; Clinical Trials; Clinical effectiveness; Computer software; Data; Decision Making; Dedications; Detection; Development; Diagnostic; Discipline of Nuclear Medicine; Disseminated Malignant Neoplasm; Dose; Early identification; Effectiveness; Evaluation; FDA approved; FOLH1 gene; Health Care Costs; Image; Image Analysis; Individual; Legal patent; Lesion; Life; Lutetium; Malignant Neoplasms; Malignant neoplasm of prostate; Manuals; Marketing; Measures; Medical; Medical Oncologist; Modality; Modeling; Molecular Target; Organ; Outcome; Output; PET/CT scan; Patient Recruitments; Patient Selection; Patient imaging; Patient-Focused Outcomes; Patients; Peptide Receptor; Performance; Phase; Physicians; Positioning Attribute; Prediction of Response to Therapy; Probability; Process; Prostatic Neoplasms; Quality of life; ROC Curve; Radiation Dose Unit; Radiation Oncologist; Radionuclide Imaging; Radionuclide therapy; Reader; Research; Research Personnel; Small Business Innovation Research Grant; Software Tools; System; Testing; Time; Toxic effect; Tracer; Treatment Efficacy; Treatment-related toxicity; Validation; castration resistant prostate cancer; clinical decision-making; clinically relevant; commercialization; cost; design; dosimetry; imaging modality; improved; molecular imaging; novel; patient response; personalized medicine; prognostic model; prospective; prostate lesions; radiotracer; receptor; receptor expression; response; rho; spatiotemporal; standard of care; theranostics; tool; treatment response; tumor; uptake; usability

Project Summary Theranostics combines molecular targeted diagnostic and therapeutic radionuclides for imaging and ther- apy in advanced malignancies, with a projected US market of more than $6.7B. Currently, metastatic castra- tion-resistant prostate cancer (mCRPC) with FDA approved lutetium-177 (177Lu)-based peptide receptor targeting radionuclide therapy (PRRT), represents the largest market. Prostate specific membrane antigen (PSMA) is the most commonly used molecular target for combined imaging and treatment of mCRPC. Recent studies have demonstrated that PSMA PET/CT has high potential to assess tumor PSMA status, treatment response assessment, and treatment-related toxicities in mCRPC. However, due to the lack of commercial image analysis software tools, the full potential of theranostic patient imaging is underutilized clinically. Currently, treating clinicians cannot fully utilize the information provided by molecular images, because manual image assessment is both laborious and subjective. Currently, there are no tools to combine and automate (1) cross-modality radiotracer uptake concordance (e.g.PSMA PET/CT vs. CT), (2) assessment of individual lesion response for all lesions, and (3) early identification of critical organ toxicity, nor can any compute all three simultaneously, quantitatively, and efficiently. Therefore, it is crucial to have a dedicated and optimized theranostics tool that provides quantitative information for all three assessments to help understand the interplay between lesion response, treatment-related toxicities, organ and lesion radiation dose estimates, target receptor expression, and the impact of each of these factors on predicting patient outcomes. To meet these challenges, AIQ Solutions proposes to develop a dedicated, AI-powered theranostics product called TRAQinform Theranostics for theranostic patient management that provides a comprehensive spatio- temporal analysis of theranostic response including: (1) quantification of target receptor status on a lesion-by- lesion basis to optimize theranostic patient selection, (2) quantification and prediction of treatment efficacy, including response of all tumor lesions, and (3) quantification and prediction of treatment-related toxicities in critical organs. Successful development of TRAQinform Theranostics will provide treating clinicians and researchers with actionable, quantitative, and clinically relevant decision-making data much earlier in the treatment process, thus improving clinical outcomes, improving quality of life and reducing therapy costs. This novel software will be integrated into AIQ’s patented, FDA 510(k)-cleared suite of treatment response assessment software.

项目摘要 Theranostics结合了分子靶向诊断和治疗放射性核素，用于成像和治疗。 APY用于晚期恶性肿瘤，预计美国市场将超过67亿美元。目前，转移性卡斯特拉- FDA批准的基于Lu-177(177Lu)多肽受体的耐药前列腺癌(MCRPC) 靶向放射性核素治疗(PRRT)，代表着最大的市场。前列腺特异性膜抗原 聚甲基丙烯酸甲酯(PSMA)是mCRPC联合成像和治疗最常用的分子靶点。近期 研究表明，PSMA PET/CT在评估肿瘤PSMA状态、治疗方面具有很高的潜力 MCRPC的反应评估和与治疗相关的毒性。然而，由于缺乏商业广告， 图像分析软件工具，治疗鼻窦炎患者成像的全部潜力在临床上没有得到充分利用。 目前，治疗临床医生不能充分利用分子图像提供的信息，因为 人工图像评估既费力又主观。目前，还没有工具来组合和 自动化(1)跨模式放射性示踪剂摄取一致性(例如，PSMA PET/CT与CT)，(2)评估 对所有病变的个别病变反应，以及(3)早期识别关键器官毒性，也不能 同时、定量、高效地计算所有这三项。因此，拥有一支敬业的 和优化的治疗声学工具，为所有三项评估提供量化信息，以帮助 了解损伤反应、治疗相关毒性、器官和损伤辐射之间的相互作用 剂量估计、靶受体表达以及这些因素对预测患者的影响 结果。为了应对这些挑战，AIQ Solutions建议开发一种专门的、以AI为动力的 Theranostics产品名为TRAQinform Theranostics，用于治疗厌食症患者管理，提供 治疗反应的综合时空分析包括：(1)靶点的量化 在逐个病变的基础上的受体状态，以优化治疗患者的选择，(2)量化和 治疗效果的预测，包括所有肿瘤病变的反应，以及(3)量化和预测 关键器官中与治疗相关的毒性。 TRAQinform Theranostics的成功开发将为临床医生和研究人员提供治疗 在治疗早期提供可操作的、定量的和临床相关的决策数据 过程，从而改善临床结果，提高生活质量和降低治疗成本。这部小说 软件将被集成到AIQ获得专利的FDA 510(K)批准的治疗反应评估套件中 软件。