One-click Automated 3D Treatment Planning for Radiopharmaceutical Therapy

用于放射性药物治疗的一键式自动化 3D 治疗计划

• 批准号: 10678173
• 负责人: Joseph Grudzinski
• 金额: $ 200万
• 依托单位: VOXIMETRY, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10678173
• 关键词: 3-Dimensional; Acceleration; Address; Adoption; Algorithms; Antibodies; Artificial Intelligence; Automation; Benchmarking; Biodistribution; Calibration; Cancer Patient; Characteristics; Clinic; Clinical; Computer software; Consensus; Contracts; Deposition; Development; Disseminated Malignant Neoplasm; Dose; Drug Kinetics; Ensure; Evaluation; External Beam Radiation Therapy; Funding; Gamma Rays; Goals; Grant; Healthcare Systems; Image; Intellectual Property; Lead; Lymphoma; Marketing; Metastatic Prostate Cancer; Methods; Modeling; Neoplasm Metastasis; Neuroendocrine Tumors; Normal tissue morphology; Organ; Overdose; Patient-Focused Outcomes; Patients; Peptides; Pharmaceutical Preparations; Phase; Physicians; Physiology; Radiation; Radioactivity; Radioisotopes; Radiopharmaceuticals; Reporting; Resources; Risk; Route; Secure; Small Business Innovation Research Grant; System; Technology; Testing; Therapeutic; Time; Treatment outcome; Tumor Tissue; Validation; Work; absorption; automated segmentation; cancer therapy; chemotherapy; clinical decision support; clinical practice; clinically significant; commercialization; cost effective; design; digital; dosimetry; experience; image registration; individual patient; individualized medicine; neoplastic cell; personalized medicine; pharmacokinetic model; reconstruction; response; side effect; single photon emission computed tomography; small molecule; theranostics; tool; treatment planning; tumor; uptake; user-friendly; verification and validation

PROJECT SUMMARY/ABSTRACT The Radiopharmaceutical Therapy (RPT) market is projected to surpass the Technitium-99m market by 2025, with an emphasis on metastatic prostate cancer, neuroendocrine tumors, and lymphoma. Driven by well- tolerated treatments and fewer side-effects, experts have estimated 150 new theranostic centers will be needed in the U.S. to deliver an estimated 50,000–200,000 treatment cycles/year. Currently, all RPT treatments administer a standard therapeutic dose despite unique patient physiology and pharmacokinetics. From experience with external beam radiation therapy (EBRT), we know that patient-specific prescriptions based on absorbed dose leads to better patient outcomes. A key technology required to enable this personalization is fast, accurate, whole-body patient-specific dosimetry. In a prior Phase II SBIR, Voximetry was able to integrate our fully benchmarked and IP-protected Monte Carlo dosimetry algorithm into a cost-effective RPT treatment planning solution (TorchTM) by adding additional features such as image registration, contour propagation, and voxel-based pharmacokinetic (PK) modeling. Torch was designed to model uptake and clearance routes of any drug class (e.g., small molecules, peptides, antibodies) and any radionuclide, effectively adding a ‘swiss army knife’ tool into the clinician’s RPT toolkit. Leveraging the gamma rays emitted by the RPT agent, Torch can calculate how much radiation energy is deposited within each voxel of organs and tumors throughout the body. Estimates of voxel-level whole-body patient-specific dosimetry are better correlated with response than the standard uptake value (SUV) information that is clinically available today. Using this approach, Voximetry has developed a fast, accurate, RPT treatment planning solution aimed to inform clinicians with extremely accurate voxel-based Monte Carlo (MC) dosimetry in a matter of minutes. Additionally, Vox has developed a GPU accelerated Monte Carlo SPECT reconstruction algorithm that leads to dosimetry estimates which differ from conventional reconstruction algorithms by at least 25%, which is seen as clinically significant. This information will support clinical decisions to personalize safe therapeutic doses. Automation of this RPT dosimetry workflow is especially important for healthcare systems that would like to implement dosimetry-guided therapy in clinical practice but are currently ill-equipped in terms of expertise and resources to perform advanced dosimetry for RPT. By enabling automation, Vox will ultimately benefit cancer patients by making available a personalized treatment that targets metastatic cancer that in many cases is more efficacious and has fewer side effects than chemotherapy. The specific aims that will be accomplished in the proposal are to (1) Develop automated segmentation tools for organs and risk and tumors using artificial intelligence, (2) develop scanner calibration, partial volume correction, and Monte Carlo reconstruction to ensure accurate SPECT imaging, and (3) automate, implement, and validate end-to-end clinical Torch workflow. The successful completion of these aims will help break down barriers to commercialization and accelerate market adoption of Torch.

项目总结/摘要 放射性药物治疗（RPT）市场预计到2025年将超过Technitium-99 m市场， 重点是转移性前列腺癌、神经内分泌肿瘤和淋巴瘤。以良好的驱动力- 专家们估计，需要150个新的治疗诊断中心， 在美国，估计每年提供50，000 - 200，000个治疗周期。目前，所有RPT治疗 尽管患者生理学和药代动力学独特，但施用标准治疗剂量。从 根据体外射束放射治疗（EBRT）的经验，我们知道，基于 吸收剂量导致更好的患者结果。实现这种个性化所需的关键技术是快速， 准确的全身患者特定剂量测定。在之前的第二阶段SBIR中，血氧测定能够整合我们的 将完全基准化和IP保护的Monte Carlo剂量测定算法转化为具有成本效益的RPT治疗 规划解决方案（TorchTM），通过添加额外的功能，如图像配准，轮廓传播， 基于体素的药代动力学（PK）建模。火炬的设计是为了模拟任何 药物类别（例如，小分子、缩氨酸、抗体）和任何放射性核素，有效地增加了一支“瑞士军队 将“刀”工具放入临床医生的RPT工具包中。利用RPT药剂发出的伽马射线，Torch可以 计算有多少辐射能量沉积在整个身体的器官和肿瘤的每个体素内。 体素水平的全身患者特异性剂量测定的估计值与反应的相关性优于 标准摄取值（SUV）信息，目前临床上可用。使用这种方法，血氧测定法 开发了一种快速、准确的RPT治疗计划解决方案，旨在为临床医生提供极其准确的 基于体素的蒙特卡罗（MC）剂量测定。此外，Vox还开发了一种GPU， 加速蒙特卡罗SPECT重建算法，导致剂量测定估计值与 常规重建算法至少25%，这被视为具有临床意义。这些信息 将支持个性化安全治疗剂量的临床决策。该RPT剂量测定工作流程的自动化 对于希望在临床中实施剂量测定引导治疗的医疗保健系统尤其重要 实践，但目前在专业知识和资源方面装备不足，无法进行高级剂量测定， RPT。通过实现自动化，Vox最终将通过提供个性化的 靶向转移性癌症的治疗，在许多情况下， 化疗该提案的具体目标是：（1）开发自动化 使用人工智能的器官、风险和肿瘤分割工具，（2）开发扫描仪校准， 部分体积校正和蒙特卡罗重建，以确保准确的SPECT成像，和（3）自动化， 实施并验证端到端临床Torch工作流程。这些目标的成功实现将有助于 打破商业化障碍，加速Torch的市场采用。