Modular Radiopharmaceutical Processing and Delivery Unit

描述（由申请人提供）：

DESCRIPTION (provided by applicant): The rapid increase in utilization of radiopharmaceuticals for imaging purposes and in novel treatment modalities that use highly radioactive compounds magnifies the need for specialized devices to minimize operator radiation exposure. The long-term goal of this project is to develop a commercially viable, automated system integrating both the processing and delivery of radiopharmaceuticals for intravenous injection, which minimizes or eliminates radiation exposure to administering personnel. The immediate application is the preparation and delivery of gaseous nitrogen-13 (13N) in saline solution, a radio- pharmaceutical agent used in lung functional imaging with Positron Emission Tomography (PET). This imaging technique, currently used in research studies at Massachusetts General Hospital (MGH), allows the detailed assessment of local pulmonary perfusion (Q), shunt fraction (Qs/Qr), ventilation (VA), gas trapping and V/Q distribution from a single isotope injection. The resulting physiologic data is particularly useful in translational research yielding the functional information needed to assess the effectiveness of therapeutic interventions, and to interpret the novel imaging data provided by PET, such as inflammatory cell activity and gene expression. Phase I research will be used to: . Produce a design for an ultra-low emissions, automated processing unit for 13N, which can be readily adapted to the processing of other radiopharmaceuticals. . Test and demonstrate novel techniques for remote injectate analysis and process monitoring with the goal of eliminating operator exposure at the point of administration. . Based on these tests, develop a design for a remote analysis and delivery unit for 13N-saline. . Apply a comprehensive failure-mode analysis to the total system design to identify and eliminate potential safety issues resulting from multiple component and procedural failures.