EPR scanner for tumor oximetry in the clinic

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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.