Carbon-11 Radiopharmaceutical Production System

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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.