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，该核心的主要工作是为接受RPT的患者进行主成像试验 约翰·霍普金斯（Johns Hopkins）的治疗，以及在研究人员之间建立深入的研究合作 合作者和行业赞助商。对于AIM 1，核心调查人员将进行主成像试验 （Seetotreat）以获取P01项目的数据，并具有灵活性，可以包括接受护理标准或 研究其他协议。对于AIM 2，Sgouros博士，Kiess博士和研究人员已经建立了 与拜耳（227th-her2-TTC和227th-pSMA-TTC）的深度研究合作，Rayzebio（225AC-- Dotatate）和Cornell（225AC-J591）支持P01项目以及未来的协作工作。这些 研究合作将包括共享图像和正在进行的临床研究的数据， 包括SPECT Dosimetry，PET替代图像和响应数据。行业研究协议是 现在完全执行。对于目标3和4，核心将建立一个被识别的图像数据库，被吸收 剂量，肿瘤反应和毒性数据。这将包括Seetotreat，Ravens和 来自行业和学术合作者。