SOFTWARE FOR OPTIMAL COMBINATION OF EXTERNAL BEAM RADIOTHERAPY (XRT) AND RADIOPHARMACEUTICAL THERAPY (RPT)

用于优化外束放射治疗 (XRT) 和放射药物治疗 (RPT) 组合的软件

• 批准号: 9578314
• 负责人: Mickel Ghaly
• 金额: $ 29.95万
• 依托单位: RADIOPHARMACEUTICAL IMAGING AND DOSIMETRY, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-18 至 2018-06-17
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9578314
• 关键词: Clinical; Clinical Data; Clinical Research; Clinical Trials; Computer software; Data; Devices; Documentation; Dose; Dose-Rate; External Beam Radiation Therapy; Feedback; Goals; Grant; Investigation; Label; Legal patent; Malignant Neoplasms; Manuals; Maps; Methods; Patients; Phase; Preparation; Process; Radiation therapy; Radiopharmaceuticals; Samarium 153; System; Testing; Time; Toxic effect; United States National Institutes of Health; Validation; X-Ray Computed Tomography; commercialization; design; dosimetry; osteosarcoma; prospective; quantitative imaging; single photon emission computed tomography; tool; treatment planning; tumor

With 20+ years of NIH-R01 grant support the Frey and Sgouros labs have developed quantitative imaging and patented dosimetry methods that enable treatment planning of combination external beam radiotherapy (XRT) and radiopharmaceutical therapy (RPT). Combination XRT-RPT is orthogonal in terms of toxicity. RPT is especially suitable for disseminated cancer while providing a dose boost to tumors targeted by XRT. The overall workflow is to reconstruct and quantify the SPECT/CT images from RPT planning study, calculate dose-rate maps at each time point, integrate the dose-rate maps to create a dose map, using radiobiological principles convert the dose map to be consistent with XRT doses and combine this with a Sim-CT for import into an XRT dose planning system. The current implementation involves several discrete software packages and manual conversion steps and is tedious, error prone, and not suitable for clinical implementation or commercialization. The overall objective of this Phase I application is create a single streamlined, robust, integrated, and validated software package for combining RPT and XRT. We will: (1) Create develop the integrated software; (2) validate it using existing clinical data; and (3) prepare to submit an FDA IDE in preparation for the proposed trial in Phase II.

在NIH-R01 20多年的赠款支持下，Frey和Sgouros实验室开发了定量成像和专利剂量测量方法，使体外放射治疗(XRT)和放射药物治疗(RPT)相结合的治疗计划成为可能。就毒性而言，XRT-RPT组合是正交性的。RPT特别适合于播散性癌症，同时为XRT靶向的肿瘤提供剂量提升。整个工作流程是重建和量化RPT计划研究的SPECT/CT图像，计算每个时间点的剂量率图，整合剂量率图以创建剂量图，利用放射生物学原理将剂量图转换为与XRT剂量一致的剂量图，并将其与Sim-CT结合以导入XRT剂量计划系统。目前的实施涉及多个离散的软件包和手动转换步骤，且繁琐、容易出错，不适合临床实施或商业化。此第一阶段应用程序的总体目标是创建用于组合RPT和XRT的单个简化、健壮、集成且经过验证的软件包。我们将：(1)创建开发集成软件；(2)使用现有临床数据对其进行验证；以及(3)准备提交FDA集成开发环境，为拟议的 第二阶段的试验。