EPR scanner for tumor oximetry in the clinic

用于临床肿瘤血氧测定的 EPR 扫描仪

• 批准号: 10586942
• 负责人: PERIANNAN KUPPUSAMY
• 金额: $ 62.67万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-01 至 2027-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10586942
• 关键词: Address; Animal Model; Automation; Cancer Patient; Clinic; Clinical; Clinical Protocols; Clinical Research; Computer software; Coupling; Custom; Data; Data Analyses; Data Collection; Data Reporting; Decision Making; Development; Devices; Diagnostic; Documentation; Electron Spin Resonance Spectroscopy; Engineering; Evaluation; Generations; Good Manufacturing Process; Guidelines; Human; Linear Accelerator Radiotherapy Systems; Magnetic Resonance Imaging; Malignant Neoplasms; Marketing; Measurement; Measures; Medical Device; Medical Technology; Monitor; Morphologic artifacts; Motivation; Movement; National Cancer Institute; Oncology; Oxygen; Oxygen saturation measurement; Patients; Performance; Peripheral Vascular Diseases; Physiologic pulse; Prognosis; Program Research Project Grants; Radiation Oncology; Radiation therapy; Research; Resource-limited setting; Resources; Role; Safety; Site; Speed; System; Technology; Testing; Therapeutic; Time; Tissues; Translating; Treatment outcome; Underserved Population; Work; achievement test; cancer care; cancer therapy; clinical care; clinical research site; cohort; college; commercialization; data acquisition; design; design and construction; diabetic; digital; effective therapy; efficacy evaluation; ergonomics; flexibility; healthy volunteer; heart motion; human subject; image guided; image guided radiation therapy; improved; in vivo; industry partner; innovation; innovative technologies; instrumentation; light weight; manufacture; medical schools; novel; operation; phantom model; prototype; respiratory; response; safety and feasibility; success; therapy outcome; tissue phantom; tool; treatment strategy; tumor; usability; user-friendly

PROJECT SUMMARY This academic-industrial partnership (AIP) proposal seeks to develop a robust and easy-to-use clinical scanner for tumor oxygen measurement (oximetry) in cancer patients. By knowing quantitative tumor oxygen levels in real time, radiotherapy could be better planned and delivered at times when there will be an optimal therapeutic ratio, thus significantly improving cancer care. The proposed approach seeks to leverage the unique capabilities of the in vivo electron paramagnetic resonance (EPR) oximetry technology that we have developed for measurement in human subjects into a medical device that is ready for routine clinical use. The scanner can make direct and repeated measurements of tumor oxygen by typical end-users in a clinical setting. The EPR research team at the Geisel School of Medicine (Dartmouth College) has successfully demonstrated the clinical feasibility and safety of EPR oximetry for measuring tumor oxygen in the clinic, and now seeks to expand upon that success through a collaborative partnership with ViewRay®, a medical-device company that is engaged in MRI image-guided radiation therapy. The clinical scanner will be designed to make it easier to operate by clinical staff and sufficiently robust and reliable for its intended use in a variety of clinical settings. The following specific aims are proposed to achieve the overall objective of developing an advanced EPR scanner for oximetry that is ready to be manufactured and used in routine clinical care to enhance cancer therapy: (Aim 1) Design and construct a 600-MHz pulse EPR system for clinical oximetry; (Aim 2) Fabricate a new class of compact, lightweight, and advanced resonator designs specifically optimized for pO2 measurements in human tumors; (Aim 3) Develop hardware and software interface with advanced measurement capabilities and user-friendly operation suitable for use in the clinic; (Aim 4) Assemble, test, and evaluate the scanner for repeated measurements of oxygen concentration using tissue phantoms and animal models of tumor; and (Aim 5) Evaluate the efficacy, usability, and safety of the oxygen scanner as a medical device and validate its use to make oxygen measurements in cancer patients and human factors engineering. The EPR scanner, fully integrated with the hardware and software modules, will be evaluated in relation to its ability to meet or exceed regulatory standards and for its practicality as a clinical device. The new first-in-clinical scanner will be a very valuable tool in the clinic for accurate prognosis and development of effective treatment strategies for cancer therapy. It can also be a valuable clinical tool for other clinical conditions where tissue oxygen is a critical variable for decision making, e.g., patients with diabetic peripheral vascular disease.

项目概要 该学术-工业合作伙伴关系 (AIP) 提案旨在开发一款强大且易于使用的临床扫描仪 通过了解癌症患者的定量肿瘤氧水平，进行肿瘤氧测量（血氧测定）。 实时，可以在有最佳治疗方案时更好地计划和实施放射治疗 比率，从而显着改善癌症护理。所提出的方法旨在利用独特的功能。 我们开发的体内电子顺磁共振 (EPR) 血氧测定技术 扫描仪可以将人体受试者的测量结果转化为可供常规临床使用的医疗设备。 由典型的最终用户在临床环境中对肿瘤氧进行直接和重复的测量。 盖泽尔医学院（达特茅斯学院）的研究团队已成功证明了临床 EPR 血氧测定法在临床上测量肿瘤氧的可行性和安全性，现在寻求扩展 这一成功得益于与 ViewRay® 的合作伙伴关系，ViewRay® 是一家医疗设备公司，致力于 MRI图像引导放射治疗的临床扫描仪将被设计成更容易被临床操作。 工作人员的支持，并且对于其在各种临床环境中的预期用途而言足够强大和可靠。 提出的目标是实现开发先进的血氧饱和度 EPR 扫描仪的总体目标 准备好生产并用于常规临床护理，以增强癌症治疗：（目标 1）设计和 构建用于临床血氧测定的 600 MHz 脉冲 EPR 系统；（目标 2）制造新型紧凑型、 轻质、先进的谐振器设计专门针对人类肿瘤的 pO2 测量进行了优化； （目标3）开发具有先进测量功能和用户友好的硬件和软件接口 适合临床使用的操作；（目标 4）重复组装、测试和评估扫描仪 使用组织模型和肿瘤动物模型测量氧浓度；以及（目标 5） 评估氧气扫描仪作为医疗设备的功效、可用性和安全性，并验证其用途 充分利用 EPR 扫描仪对癌症患者和人因工程进行氧气测量。 与硬件和软件模块集成，将根据其满足或超过的能力进行评估 监管标准及其作为临床设备的实用性将是一种非常重要的临床设备。 临床上准确预后和制定有效癌症治疗策略的宝贵工具 对于组织氧是关键变量的其他临床病症，它也可以是一种有价值的临床工具。 用于决策，例如患有糖尿病周围血管疾病的患者。