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.

项目摘要 这一学术-工业伙伴关系（AIP）提案旨在开发一种强大且易于使用的临床扫描仪 用于癌症患者的肿瘤氧测量（血氧测定）。通过了解定量的肿瘤氧水平， 真实的时间，放射治疗可以更好地计划和交付的时候，将有一个最佳的治疗 比例，从而显著改善癌症护理。拟议的方法旨在利用独特的能力， 体内电子顺磁共振（EPR）血氧测定技术，我们已经开发了用于 将人类受试者的测量结果导入准备用于常规临床使用的医疗器械中。扫描仪可以 在临床环境中由典型的终端用户对肿瘤氧进行直接和重复的测量。的EPR 盖泽尔医学院（达特茅斯学院）的一个研究小组成功地证明了 在临床上测量肿瘤氧的EPR血氧饱和度的可行性和安全性，现在寻求扩大 通过与ViewRay®的合作伙伴关系取得了成功，ViewRay®是一家医疗设备公司， MRI图像引导放射治疗。临床扫描仪的设计将使其更容易操作的临床 工作人员，并且对于其在各种临床环境中的预期用途来说足够坚固和可靠。以下具体 目的是为了实现开发一种先进的EPR扫描仪血氧测定的总体目标， 准备制造并用于常规临床护理以增强癌症治疗：（目的1）设计和 构建用于临床血氧测定的600-MHz脉冲EPR系统;（目的2）制造新型紧凑型， 重量轻，先进的谐振器设计，专门针对人体肿瘤中的pO 2测量进行了优化; (Aim 3）开发具有先进测量能力和用户友好的硬件和软件接口 （目的4）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） 评价氧气扫描仪作为医疗器械的有效性、可用性和安全性，并确认其用于 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，将根据其满足或超过 监管标准和其作为临床器械的实用性。新的首次临床扫描仪将是一个非常 在临床上用于准确预后和制定有效的癌症治疗策略的宝贵工具 疗法它也可以是一个有价值的临床工具，用于其他临床条件，其中组织氧是一个关键变量 用于决策，例如，糖尿病周围血管病变患者。