Modular Radiopharmaceutical Processing and Delivery Unit

描述(由申请人提供)： 用于成像目的的放射性药物和使用高放射性化合物的新型治疗方式的使用迅速增加，扩大了对专门设备的需要，以最大限度地减少操作员的辐射暴露。该项目的长期目标是开发一种商业上可行的自动化系统，将用于静脉注射的放射性药物的处理和交付整合在一起，最大限度地减少或消除对管理人员的辐射暴露。直接的应用是在盐水溶液中制备和输送气态氮-13(13N)，这是一种用于正电子发射断层扫描(PET)肺功能成像的放射性药剂。这种成像技术目前用于马萨诸塞州综合医院(MGH)的研究，可以通过一次同位素注射详细评估局部肺灌注(Q)、分流分数(Qs/Qr)、通气量(VA)、气体捕获和V/Q分布。由此产生的生理学数据在转译研究中特别有用，这些研究产生了评估治疗干预有效性所需的功能信息，并解释了PET提供的新的成像数据，如炎症细胞活动和基因表达。第一阶段的研究将用于： 。为13N生产一种超低排放、自动化处理单元的设计，该单元可以很容易地适应于其他放射性药物的处理。 。测试和演示远程注射分析和过程监控的新技术，目的是消除操作员在给药时的暴露。 。在这些测试的基础上，开发13N-生理盐水远程分析和输送装置的设计。 。将全面的故障模式分析应用于整个系统设计，以识别和消除由多个组件和程序故障导致的潜在安全问题。

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.