Core 3: Patient Data

核心 3：患者数据

• 批准号: 10713717
• 负责人: Ana Ponce Kiess
• 金额: $ 20.02万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10713717
• 关键词: Adherence; Adoption; Agreement; Alpha Particle Emitter; Clinical Data; Clinical Research; Collaborations; Data; Data Collection; Databases; Dose; Drug Kinetics; ERBB2 gene; Ethics; FOLH1 gene; Future; Goals; Image; Industry; J591 Monoclonal Antibody; Patient imaging; Patients; Positron-Emission Tomography; Privacy; Protocols documentation; Radiobiology; Radiopharmaceuticals; Research; Research Personnel; Scientific Inquiry; Standardization; Toxic effect; Work; absorption; data acquisition; data sharing; dosimetry; flexibility; programs; response; single photon emission computed tomography; standard of care; treatment optimization; tumor

Project Summary Overall, the primary effort of this Core will be to conduct a master imaging trial for patients undergoing RPT treatment at Johns Hopkins, as well as to establish deep research collaborations among investigators, collaborators and industry sponsors. For Aim 1, the Core Investigators will conduct a master imaging trial (SeeToTreat) to acquire data for the P01 projects, with flexibility to include patients receiving standard of care or research RPT on other protocols. For Aim 2, Dr. Sgouros, Dr. Kiess and the research staff have established deep research collaborations with Bayer (227Th-HER2-TTC and 227Th-PSMA-TTC), Rayzebio (225Ac- DOTATATE), and Cornell (225Ac-J591) to support the P01 Projects as well as future collaborative work. These research collaborations will include sharing of images and data from completed and ongoing clinical studies, including SPECT dosimetry, PET surrogate images and response data. The industry research agreements are now fully executed. For Aims 3 and 4, the Core will establish a de-identified RPT database of images, absorbed dose, tumor response and toxicity data. This will include collection of data from SEEtoTREAT, RAVENS, and from industry and academic collaborators.

项目摘要 总体而言，本核心研究的主要工作将是对接受RPT的患者进行主成像试验 治疗在约翰霍普金斯，以及建立深入的研究合作之间的研究人员， 合作者和行业赞助商。对于目标1，核心研究者将进行一项主成像试验 （SeeToTreat）采集P01项目的数据，可灵活纳入接受标准治疗的患者或 研究其他协议上的RPT。对于目标2，Sgouros博士，Kiess博士和研究人员已经建立了 与拜耳（227 Th-HER 2-TTC和227 Th-PSMA-TTC）、Rayzebio（225 Ac- DOTATATE）和康奈尔大学（225 Ac-J591）支持P01项目以及未来的合作工作。这些 研究合作将包括共享已完成和正在进行的临床研究的图像和数据， 包括SPECT剂量测定、PET替代图像和响应数据。行业研究协议包括 现已全面执行。对于目标3和4，核心将建立一个去识别的RPT图像数据库， 剂量、肿瘤反应和毒性数据。这将包括从SEEtoTREAT、RAVENS和 来自工业界和学术界的合作者。