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

• 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
• 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

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。外束放射治疗（XRT）

项目成果

An International Study of Factors Affecting Variability of Dosimetry Calculations, Part 2: Overall Variabilities in Absorbed Dose.

• DOI: 10.2967/jnumed.122.265094
• 发表时间: 2023-07
• 期刊: JOURNAL OF NUCLEAR MEDICINE
• 影响因子: 9.3
• 作者: Brosch-Lenz, Julia;Ke, Suqi;Wang, Hao;Frey, Eric;Dewaraja, Yuni K.;Sunderland, John;Uribe, Carlos
• 通讯作者: Uribe, Carlos