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.

项目概要 治疗诊断学结合了用于成像和治疗的分子靶向诊断和治疗放射性核素 治疗晚期恶性肿瘤，预计美国市场目前超过 $6.7B。 FDA 批准的基于镥 177 (177Lu) 的肽受体的抗性前列腺癌 (mCRPC) 靶向放射性核素治疗（PRRT）代表了最大的市场。 (PSMA) 是 mCRPC 联合成像和治疗最常用的分子靶点。 研究表明，PSMA PET/CT 具有评估肿瘤 PSMA 状态、治疗的巨大潜力 然而，由于缺乏商业化，mCRPC 的反应评估和治疗相关的毒性。 图像分析软件工具，治疗诊断患者成像的全部潜力在临床上尚未得到充分利用。 目前，治疗还不能充分利用分子图像提供的信息，因为 手动图像评估既费力又主观，目前还没有工具可以组合和评估。 自动化 (1) 跨模态放射性示踪剂摄取一致性（例如 PSMA PET/CT 与 CT），(2) 评估 所有病变的个体病变反应，以及（3）早期识别关键器官毒性，也不能 同时、定量、高效地计算这三者，因此拥有专用的计算机至关重要。 优化的治疗诊断工具可为所有三项评估提供定量信息，以帮助 了解病变反应、治疗相关毒性、器官和病变辐射之间的相互作用 剂量估计、目标受体表达以及这些因素对预测患者的影响 为了应对这些挑战，AIQ Solutions 建议开发一个由人工智能驱动的专用系统。 名为 TRAQinform Theranostics 的治疗诊断产品用于治疗患者管理，提供 治疗诊断反应的全面时空分析包括：（1）目标量化 逐个病变地评估受体状态，以优化治疗诊断患者选择；(2) 量化和 预测治疗效果，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 的成功开发将为治疗和研究人员提供 在治疗早期就获得可操作的、定量的和临床相关的决策数据 过程，从而改善临床结果、提高生活质量并降低治疗成本。 软件将集成到 AIQ 获得 FDA 510(k) 批准的专利治疗反应评估套件中 软件。