Combination Radiopharmaceutical Therapy and External Beam Radiotherapy

放射药物治疗与外照射放射治疗的联合治疗

基本信息

批准号：
10668390
负责人：
Robert Francois Hobbs
金额：
$ 54.8万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-03 至 2026-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10668390
关键词：
3-Dimensional Address Area Binding Biological Response Modifier Therapy Cancer Patient Characteristics Clinical Trials Combined Modality Therapy Commercial grade Computer software Data Development Digital Imaging and Communications in Medicine Disease Disparate Disseminated Malignant Neoplasm Dose Elements Endocrinology Engineering Epithelium FDA approved Grant Image Industrialization Intellectual Property Licensing Malignant Neoplasms Malignant neoplasm of thyroid Maps Marketing Medical Oncology Methodology Methods Modality Neoplasm Metastasis Normal tissue morphology Organ Output Patients Pharmacologic Substance Phase Phase I Clinical Trials Physics Prediction of Response to Therapy Qualifying Radiation Radiation Oncology Radiation Tolerance Radiation therapy Radioactive Radioactive Iodine Radiopharmaceuticals Recording of previous events Safety Software Tools Solid Solid Neoplasm System Therapeutic Thinking Tissues Toxic effect Treatment outcome United States National Institutes of Health Universities Widespread Disease Work absorption cancer cell cancer therapy cell killing chemotherapy clinical implementation cloud based commercialization dosimetry experience improved individual patient industry partner interest medical schools member multi-arm trial neoplastic cell novel radiation delivery radioiodine therapy reconstruction safety and feasibility safety assessment single photon emission computed tomography software development success targeted delivery thyroid neoplasm tool treatment optimization treatment planning tumor uptake

项目摘要

Problem: Treatment options for late stage metastatic cancer are limited. External beam radiotherapy (XRT) is generally effective, but limited against widespread disease or tumors adjacent to radiosensitive tissue. Radiopharmaceutical therapy (RPT), a therapeutic modality with origins in radioiodine therapy of thyroid cancer, has become an effective alternative to chemo- and biologic therapy. RPT is complementary to XRT. It exploits pharmaceuticals that bind to tumor cells to deliver targeted radiation. It targets metastases while providing a radiation boost to tumors. Combining XRT with RPT (e.g., as opposed to chemotherapy) allows a precise determination of potential toxicity to normal organs since both modalities involve radiation whose effects on normal tissues can be quantified and predicted by treatment planning. Our solution to treating widespread metastases is to commercialize enhanced dosimetric tools that will make combination XRT and RPT (CXRPT) a routine cancer treatment. We will assess safety and feasibility of CXRPT in thyroid cancer patients who are not likely to be effectively treated with radioiodine alone and who are good candidates for CXRPT. Radiopharmaceutical Imaging and Dosimetry, LLC (Rapid) will provide the methodology and software for CXRPT; Johns Hopkins University, School of Medicine will implement CXRPT. Specific aims: 1. Conduct a phase I clinical trial of CXRPT in differentiated thyroid cancer patients. Establish safety of CXRPT, provide a rationale for a larger multi-arm trial that will demonstrate greater efficacy over current treatment. 2. Implement the CXRPT methodology in a cloud-based software package, 3D-RD-X; validate results from the cloud-based package against the localized package. 3. Obtain data needed for eventual FDA clearance of 3D-RD-X. Aims 2 and 3 are essential steps towards generating a commercially viable software package that will enable widespread implementation of CXRPT. This proposal will introduce a novel treatment combination applicable to every cancer for which RPT exists or may be developed. The investigative team is already highly collaborative. Rapid’s founders have previously implemented advanced dosimetry for thyroid cancer patients and have a long record in this area. This proposal will enable a fundamentally new treatment paradigm that leverages widely available radiotherapy treatment with ongoing development of novel RPTs. We expect widespread implementation and commercial interest once we have demonstrated feasibility and provided the software tool to implement this treatment approach.

问题：晚期转移性癌症的治疗选择有限。通常有效，但对邻近放射敏感组织的广泛疾病或肿瘤有限。放射性药物治疗（RPT）是一种起源于甲状腺癌放射性碘治疗的治疗方式， RPT 已成为化学和生物疗法的有效替代方案，它是 XRT 的补充。与肿瘤细胞结合以提供靶向放射的药物，它可以靶向转移，同时提供治疗。将 XRT 与 RPT 相结合（例如，与化疗相反）可以实现精确的放射治疗。确定对正常器官的潜在毒性，因为两种方式都涉及辐射，其对正常器官的影响正常组织可以通过治疗计划进行量化和预测。我们治疗广泛转移的解决方案是将增强的剂量测定工具商业化，这将使 XRT 和 RPT 组合 (CXRPT) 是一种常规癌症治疗方法，我们将评估 CXRPT 的安全性和可行性。单独使用放射性碘不太可能有效治疗且病情良好的甲状腺癌患者 CXRPT 的候选者将提供该方法。 CXRPT 的软件；约翰霍普金斯大学医学院将实施 CXRPT。具体目标： 1. 在分化型甲状腺癌患者中进行CXRPT I期临床试验。确定 CXRPT 的安全性，为更大规模的多臂试验提供理论依据，以证明其更有效超过目前的治疗。 2. 在基于云的软件包 3D-RD-X 中实施 CXRPT 方法，验证结果；基于云的包与本地化包的对比。 3. 获取最终 FDA 批准 3D-RD-X 所需的数据。目标 2 和 3 是生成商业上可行的软件包的重要步骤，该软件包将能够 CXRPT 的广泛实施。该提案将引入一种新的治疗组合，适用于存在 RPT 的每种癌症 Rapid 的创始人此前已经高度协作。对甲状腺癌患者实施了先进的剂量测定，并在该领域拥有悠久的记录。将实现一种全新的治疗模式，利用广泛可用的放射治疗新型 RPT 的持续开发一旦完成，我们预计会得到广泛的实施和商业利益。已经证明了可行性并提供了实施这种治疗方法的软件工具。