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; 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.

项目摘要 这项学术工业合作伙伴关系（AIP）提案旨在开发可靠且易于使用的临床扫描仪 用于癌症患者的肿瘤氧测量（血氧仪）。通过了解定量肿瘤氧 实时，可以在有最佳疗法的情况下更好地计划和提供放射疗法 比率，因此显着改善了癌症护理。拟议的方法旨在利用独特的功能 我们已经开发的体内电子顺磁共振（EPR）血氧仪技术的 人类受试者的测量为准备常规临床用途的医疗装置。扫描仪可以 在临床环境中，通过典型的最终用户对肿瘤氧进行直接和重复测量。 EPR 盖塞尔医学院（达特茅斯学院）的研究团队成功证明了临床 EPR氧对诊所中肿瘤氧的可行性和安全性，现在试图扩展 通过与参与医疗设备的公司ViewRay®建立合作合作伙伴关系的成功 MRI图像引导的放射治疗。临床扫描仪的设计将使通过临床更容易操作 员工和足够强大且可靠地在各种临床环境中使用。以下特定 提出了目标以实现开发高级EPR扫描仪的总体目标，这是 准备在常规临床护理中制造和使用以增强癌症疗法：（ AIM 1）设计和 构建一个用于临床血氧仪的600 MHz脉冲EPR系统； （AIM 2）制造一类新的紧凑型， 轻巧且高级的谐振器设计专门针对人类肿瘤的PO2测量进行了优化； （AIM 3）开发具有高级测量功能和用户友好的硬件和软件接口 适合在诊所使用的操作； （AIM 4）组装，测试和评估扫描仪重复 使用组织幻像和肿瘤动物模型测量氧浓度； （目标5） 评估氧扫描仪作为医疗设备的效率，可用性和安全性，并验证其用途 在癌症患者和人为因素工程中进行氧气测量。 EPR扫描仪，完全 与硬件和软件模块集成在一起，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装置的实用性。新的第一个临床扫描仪将非常 诊所中有价值的工具，以准确预后和开发有效的癌症治疗策略 治疗。对于其他临床条件，它也可能是组织氧是关键变量的其他临床条件的宝贵临床工具 为了决策，例如患有糖尿病周围血管疾病的患者。