Expanding F-18 Production for PET/CT

描述（由申请人提供）：回旋加速器生产的[18F]氟脱氧葡萄糖（FDG）广泛用于临床PET/CT，用于医疗保险批准的许多癌症和阿尔茨海默病的诊断和治疗评估。回旋药房配送中心跟上了FDG成像的年度增长，FDG的基础是代谢（不同于CT和MRI的解剖）。然而，据最近预测，在未来2-4年内，除氟氯丙烷外，对18F放射性药物的需求将急剧增加，将需求扩大5-10倍。许多99mTc SPECT放射性药物依赖于99mMo发生器（源自核反应堆）的洗脱，已经使用了几十年。今天，由于长时间关闭维修少数老化反应堆（全部非美国），全球出现了反应堆生产的医用放射性核素短缺。为了取代日渐衰落的放射性药物，几年来一直在共同努力开发用于PET心脏、神经、骨骼和其他成像应用的18F放射性示踪剂。这些放射性示踪剂中有许多正在临床试验中，预计将在未来3-6年内获得批准报销。安装更多主要的11-18 MeV负离子回旋加速器，利用内部潘宁离子源（束流限制在100-150微安）并不是大规模增加产量的最有效的商业模式。一种新构思的、明显优越的方法是使用注射离子源实现更大的回旋加速器，使束流功率提高5倍，从而提供更多种类的放射性药物和更大的患者剂量。与大型集中式回旋加速器药房相关的成本远低于同等的5-6个小型回旋加速器。这种新的商业模式要求提供比申请人在2008-2009年销售的高性能商业改造目标系统耗能更高的目标。申请人于2007年底完成了两项第二阶段SBIR拨款，研究了热虹吸沸腾目标（2-6千瓦）和非沸腾再循环目标（5-20千瓦），并确定了所需的新技术是可行的。拟议项目的目标是完成研发，以实现支持基于大型集中式回旋加速器的新商业模式的原型目标，并及时准备在2013年中期进行商业实施。到那时，大多数现有的小型回旋加速器将达到满负荷，而更大的回旋加速器解决方案，战略性地放置在现有的小型回旋加速器中间，是解决增加18F生产预期需求的最有效方法。

DESCRIPTION (provided by applicant): Cyclotron produced [18F]fluorodeooxyglucose (FDG) is widely used in clinical PET/CT for Medicare approved diagnosis and therapy evaluation of many cancers and Alzheimer's. Cyclotron pharmacy distribution centers have kept pace with annual increases in imaging with FDG, whose basis is metabolic (as distinct from anatomical for CT and MRI). However, the demand for 18F radiopharmaceuticals other than FDG has recently been predicted to increase dramatically in the next 2-4 years, expanding the need for by a factor of 5-10. Numerous 99mTc SPECT radiopharmaceuticals, dependent on elution from 99mMo generators (derived from nuclear reactors) have been in use for decades. Today there is a global shortage of reactor produced medical radionuclides due to lengthy shutdowns for repair of the few aging reactors (all non-US). To replace waning radiopharmaceuticals, a concerted effort has been underway for several years to develop 18F radiotracers for PET cardiac, neurological, bone, and other imaging applications. Many of these radiotracers are in clinical trials, and are expected to be approved for reimbursement in the next 3-6 years. Installing more of the predominant 11-18 MeV negative ion cyclotrons utilizing internal Penning ion sources (beam current limited to100-150 microamps) is not the most efficient business model for a large increase in production. A newly conceived and significantly superior approach is to implement larger cyclotrons with injection ion sources that permit beam power a factor of five higher, providing a greater variety of radiopharmaceuticals and larger patient dose volumes. Costs associated with a larger centralized cyclotron pharmacy are much lower than the equivalent 5-6 smaller cyclotrons. This new business model requires availability of targets capable of higher energy dissipation than the applicant's high performance commercial retrofit target systems sold in 2008-2009. The required new technology was established as feasible by the applicant's two Phase 2 SBIR grants completed at the end of 2007, which studied both thermosyphon boiling targets (2-6 kW) and non-boiling recirculating targets (5-20 kW). The goal of the proposed project is to accomplish R&D to implement prototype targets supporting the new business model based on larger centralized cyclotrons, in time to be ready for commercial implementation in mid 2013. Most existing small cyclotrons will have reached full capacity by that time, and the larger cyclotron solution, strategically placed in the midst of existing smaller cyclotrons, is the most efficacious way to address the expected need for increased 18F production. PUBLIC HEALTH RELEVANCE: Alzheimer's Dementia, cardiovascular disease and cancer are increasingly serious public health problems. PET/CT diagnosis and treatment planning has a profound impact on determining the most effective course of patient care. Flourine-18 labeled radiopharmaceuticals are the most important agents for this imaging modality. The overall goal of this project is to significantly increase the availability of fluorine-18 labeled radiopharmaceuticals by developing economical, large scale cyclotron production methods for the fluorine-18 radionuclide.