Carbon-11 Radiopharmaceutical Production System

描述（由申请人提供）：麻省总医院长期以来一直是开发和应用PET技术解决生物医学重要问题的先驱。MGH PET成像项目得到了美国国立卫生研究院资助的研究项目的积极支持，这些研究涉及实验药理学、肿瘤生物学、分子成像和认知神经科学等领域的基础问题。MGH PET成像的努力已经取得了巨大的成功，将最近的科学发展从实验室转化为床边。使用PET成像来解决特定的与患者相关的临床问题已经急剧增加，特别是在肿瘤学、神经病学和心脏病学领域。由于越来越多的人意识到使用PET来促进患者护理的临床影响，对医院校园内现有的MGH PET设施的临床需求正在上升；鉴于临床使用需求的增加和设备的老化，该设施的研究活动增长潜力有限。该设施已经不堪重负，无法满足不断增长的研究需求，以推动PET的发展，并可能在研究园区配备专门的研究设施。最初，查尔斯敦的研究专用PET成像设施将在马蒂诺斯中心安装两个成像设备：2008年初安装的首个PET- mr组合成像系统，以及目前在主校区临时实验室运行的Concord微型PET动物成像系统，一旦回旋加速器和其他必要的放射性药物资源启动并工作，将转移到查尔斯敦设施。随着项目的发展，计划要求增加更多的成像仪器。拟议的C-11合成器将成为新PET设施合成放射性配体能力的关键组成部分，用于正在进行和计划中的研究项目。鉴于卓越的生物医学成像研究社区位于MGH研究园区，Martinos中心广泛的多模态成像资源，现有MGH临床园区PET设备的严重超负荷状态，以及现有的技术专长和基础设施，拟议的C-11放射性药物生产系统将立即提高现有研究的效率，可及性和创新。并在完成MGH提供包括PET成像在内的综合生物医学成像研究环境的战略中发挥关键作用。拟议的C-11放射性药物生产系统具有目前可用于生产C-11标记放射性药物的商业系统的最高性能。合成器必须在设计中平衡许多因素，以满足性能、可访问性和适合研究环境的要求。

DESCRIPTION (provided by applicant): The Massachusetts General Hospital has long been a pioneer in the development and application of PET technology to problems of biomedical importance. The MGH PET imaging program is actively supported by NIH-funded research addressing questions of fundamental importance in fields such as experimental pharmacology, tumor biology, molecular imaging, and cognitive neuroscience. The MGH PET imaging effort has had great success in translating recent scientific developments from the bench to the bedside. The use of PET imaging to address specific patient-related clinical questions has risen dramatically, especially in the areas of oncology, neurology, and cardiology. As a result of growing awareness about the clinical impact of using PET to promote patient care, clinical demands on the existing MGH PET facility on the hospital campus are escalating; this facility has limited growth potential for research activity, given both increasing demands for clinical use and the age of the equipment. Already overburdened, the facility cannot keep pace with growing research demands of the scope necessary to advance PET development-and possible with dedicated research facilities at the research campus. Initially, the research-dedicated PET imaging facility in Charlestown will have two imaging devices located at the Martinos Center: a first-of-its-kind combined PET-MR imaging system installed in early 2008, and a Concord microPET system for animal imaging that is currently operating in a temporary laboratory on the main campus and will be transferred to the Charlestown facility once the cyclotron and other essential radiopharmaceutical resources are up and working. Plans call for additional imaging instruments to be added as the program grows. The proposed C-11 synthesizer will be a critical component of the new PET facility's capabilities to synthesize radioligands for ongoing and planned research projects. Given the exceptional biomedical imaging research community co-located at the MGH research campus, the broad multimodality imaging resources of the Martinos Center, the critically overburdened state of the existing MGH clinical campus PET facilities, and the existing technical expertise and infrastructure in place, the proposed C-11 radiopharmaceutical production system will immediately increase the efficiency, accessibility, and innovation of existing research, and play a critical role in completing the MGH's strategy to provide an integrated biomedical imaging research environment that includes PET imaging. The proposed C-11 radiopharmaceutical production system has the highest performance of the commercial systems currently available for production C-11 labeled radiopharmaceuticals. The synthesizer must balance a number of factors in the design to fulfill requirements for performance, accessibility and fitness to the research environment. PUBLIC HELATH RELEVANCE: In compliance with FDA cGMP guidelines and USP 797, we propose to establish carbon-11 radiopharmaceutical production. Given the exceptional biomedical imaging research community co-located at the MGH research campus, the broad multi-modality imaging resources of the Martinos Center, the critically overburdened state of the existing MGH clinical campus PET facilities, and the existing technical expertise and infrastructure in place, the proposed C-11 radiopharmaceutical production system has the potential to immediately increase the efficiency, accessibility, and innovation of research programs at the institution, and complete the MGH's strategy to provide an integrated biomedical imaging research environment.