SBIR PHASE I TOPIC 392: TARGETED RADIONUCLIDE THERAPY OF METASTATIC LIVER CANCER: PATIENT SPECIFIC OPTIMIZATION

SBIR 第一阶段主题 392：转移性肝癌的靶向放射性核素治疗：针对患者的优化

• 批准号: 10032840
• 负责人: MICHAEL GHALY
• 金额: $ 29.93万
• 依托单位: RADIOPHARMACEUTICAL IMAGING AND DOSIMETRY, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-16 至 2020-06-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10032840
• 关键词: 3-Dimensional; 90Y; Cancer Patient; Catheters; Clinical Trials; Computer software; Diagnosis; Disease; Dose; Fluoroscopy; Future; Goals; Hepatic artery; Hepatotoxicity; Image; Institutional Review Boards; Label; Literature; Liver; Malignant neoplasm of liver; Maximum Tolerated Dose; Measures; Metastatic Neoplasm to the Liver; Methodology; Methods; Microspheres; Modeling; Normal tissue morphology; Organ; Patient-Focused Outcomes; Patients; Phase; Pilot Projects; Radiation; Radiation therapy; Radioembolization; Radionuclide therapy; Radiopharmaceuticals; Regimen; Reproducibility; Risk; Services; Small Business Innovation Research Grant; Technetium Tc 99m Aggregated Albumin; Testing; Therapeutic; Tissues; Toxic effect; Tumor Burden; Variant; Work; X-Ray Computed Tomography; base; cloud based; design; dosimetry; improved; improved outcome; individual patient; metastatic colorectal; patient population; quantitative imaging; reconstruction; recruit; response; single photon emission computed tomography; therapy outcome; treatment planning; tumor; tumor progression; uptake; web app

Radioembolization using Y-90 microspheres delivered into the hepatic artery under fluoroscopy guidance has slowed tumor progression in the liver for patients diagnosed with metastatic colorectal cancer (mCRC). Treatment planning is based on a simple estimate of the average absorbed dose (AD) delivered to the treated volume; tumor dose thus depends on tumor burden and tumor-to-background ratio, resulting in under-dosing in some patients. Dosing based on more rigorous, patient-specific AD to normal liver would allow safely increasing administered activity, likely improving tumor response, without an increased toxicity. The goal of this work is to improve the outcome of patients with mCRC by implementing a cloud-based treatment planning software service using rigorous quantitative imaging and dosimetry methods. We will perform a pilot study involving 3 patients to demonstrate feasibility of recruiting, imaging, and performing the treatment planning, validate the reproducibility catheter placement, add and verify quantitative Tc-99m MAA SPECT/CT reconstruction capability, verify that AD to normal treated liver estimated from Tc-99m MAA predicts the normal liver AD measured using quantitative Y-90 bremsstrahlung SPECT, validate automated segmentation of liver in Tc-99m MAA SPECT/CT images, develop and validate a proof-of-principle cloud-based software service; and obtain approval for the Phase II project’s dose escalation trial.

在荧光透视引导下，使用Y-90微球递送到肝动脉中的放射性栓塞减缓了诊断为转移性结直肠癌（mCRC）患者的肝脏肿瘤进展。治疗计划基于对输送至治疗体积的平均吸收剂量（AD）的简单估计;因此，肿瘤剂量取决于肿瘤负荷和肿瘤与背景的比例，导致某些患者剂量不足。基于对正常肝脏的更严格的患者特异性AD的给药将允许安全地增加施用的活性，可能改善肿瘤反应，而不增加毒性。 这项工作的目标是通过使用严格的定量成像和剂量测定方法实施基于云的治疗计划软件服务来改善mCRC患者的结局。我们将进行一项涉及3名患者的试点研究，以证明招募、成像和执行治疗计划的可行性，验证导管放置的可重复性，添加并验证定量Tc-99 m MAA SPECT/CT重建能力，验证根据Tc-99 m MAA估计的正常治疗肝脏的AD预测使用定量Y-90制动辐射SPECT测量的正常肝脏AD，验证Tc-99 m MAA SPECT/CT图像中肝脏的自动分割，开发和验证基于云的原理验证软件服务;并获得II期项目剂量递增试验的批准。