Carbon-11 Radiopharmaceutical Production System

碳11放射性药物生产系统

• 批准号: 7793056
• 负责人: ANNA-LIISA BROWNELL
• 金额: $ 46.24万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-01 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7793056
• 关键词: Address; Age; Animals; Area; Awareness; Carbon; Cardiology; Clinical; Communities; Cyclic GMP; Cyclotrons; Development; Environment; Equilibrium; Equipment; Funding; General Hospitals; Growth; Guidelines; Hospitals; Image; Imaging Device; Institution; Label; Laboratories; Magnetic Resonance Imaging; Massachusetts; Neurology; Patient Care; Patients; Performance; Pharmacology; Play; Positron-Emission Tomography; Production; Radiopharmaceuticals; Research; Research Activity; Research Infrastructure; Research Project Grants; Resources; Role; System; Technical Expertise; Technology; Translating; Tumor Biology; Work; bench to bedside; bioimaging; cognitive neuroscience; design; fitness; imaging modality; innovation; instrument; molecular imaging; multimodality; oncology; programs; radioligand; research facility; success

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.

描述（由申请人提供）：麻省总医院长期以来一直是 PET 技术开发和应用以解决生物医学重要性问题的先驱。 MGH PET 成像项目得到了 NIH 资助的研究的积极支持，这些研究解决了实验药理学、肿瘤生物学、分子成像和认知神经科学等领域的根本性重要问题。 MGH PET 成像工作在将最新科学发展从实验室转化为临床方面取得了巨大成功。使用 PET 成像来解决与患者相关的特定临床问题的情况急剧增加，特别是在肿瘤学、神经病学和心脏病学领域。由于人们越来越认识到使用 PET 促进患者护理的临床影响，对医院园区内现有 MGH PET 设施的临床需求不断增加；鉴于临床使用需求不断增加和设备老化，该设施的研究活动增长潜力有限。该设施已经不堪重负，无法跟上不断增长的研究需求，而这些需求是推进 PET 发展所必需的，并且可以通过研究园区的专用研究设施来实现。最初，查尔斯敦的研究专用 PET 成像设施将在 Martinos 中心配备两台成像设备：一个是 2008 年初安装的首个组合 PET-MR 成像系统，另一个是用于动物成像的 Concord microPET 系统。目前在主校区的一个临时实验室中运行，一旦回旋加速器和其他重要的放射性药物资源启动并运行，将转移到查尔斯顿设施。随着项目的发展，计划要求添加额外的成像仪器。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的研究项目。鉴于 MGH 研究园区拥有卓越的生物医学成像研究社区、Martinos 中心广泛的多模态成像资源、现有 MGH 临床园区 PET 设施严重超负荷的状态，以及现有的技术专业知识和基础设施，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、可及性和创新性，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方面发挥关键作用。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中的最高性能。合成器必须平衡设计中的许多因素，以满足性能、可访问性和研究环境适应性的要求。 公共健康相关性：根据 FDA cGMP 指南和 USP 797，我们建议建立碳 11 放射性药物生产。鉴于 MGH 研究园区内拥有卓越的生物医学成像研究社区、Martinos 中心广泛的多模态成像资源、现有 MGH 临床园区 PET 设施严重超负荷的状态，以及现有的技术专业知识和基础设施，拟议的 C-11 放射性药物生产系统有可能立即提高该机构研究项目的效率、可及性和创新性，并完成 MGH 提供综合生物医学成像研究环境的战略。