EPR scanner for tumor oximetry in the clinic

项目总结 这项学术-产业合作(AIP)计划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血氧测量(血氧仪)。通过了解肿瘤组织中的定量氧气水平 实时，放射治疗可以更好地计划和实施，在有最佳治疗方案的时候 因此，显著改善了癌症护理。建议的方法寻求利用独特的能力 体内电子顺磁共振(EPR)血氧测定仪技术 将人体测量放入可供临床常规使用的医疗设备中。扫描仪可以 在临床环境中由典型的最终用户对肿瘤氧气进行直接和重复测量。《环境政策报告》 盖泽尔医学院(达特茅斯学院)的研究小组成功地展示了临床 EPR血氧测定仪在临床上测量肿瘤血氧的可行性和安全性，现寻求扩展 这一成功是通过与医疗设备公司ViewRay®的合作伙伴关系实现的，该公司致力于 核磁共振影像引导放射治疗。临床扫描仪的设计将使其更易于临床操作 具有足够的耐用性和可靠性，可在各种临床环境中使用。以下是具体的 提出的目标是实现开发用于血氧测定的先进EPR扫描仪的总体目标，即 准备生产并用于常规临床护理，以加强癌症治疗：(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， 轻巧、先进的谐振器设计，专门针对人体肿瘤的PO2测量进行了优化； (目标3)开发具有先进测量能力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)组装、测试和评估扫描仪的重复使用 使用组织模体和肿瘤动物模型测量氧浓度；和(目标5) 评估氧气扫描仪作为医疗设备的有效性、可用性和安全性，并验证其使用情况 在癌症患者和人为因素工程学中进行氧气测量。EPR扫描仪，完全 与硬件和软件模块集成，将根据其达到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。新的临床首台扫描仪将是一款非常 为癌症的准确预后和制定有效的治疗策略提供有价值的临床工具 心理治疗。对于组织氧是关键变量的其他临床情况，它也是一种有价值的临床工具 用于决策，例如糖尿病周围血管疾病患者。

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.