Expanding F-18 Production for PET/CT

扩大用于 PET/CT 的 F-18 生产

• 批准号: 7926652
• 负责人: Bruce Wendell Wieland
• 金额: $ 153.25万
• 依托单位: BRUCE TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-09 至 2013-09-08
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7926652
• 关键词: Address; Aging; Alzheimer' s Disease; Businesses; Cardiac; Cardiovascular Diseases; Characteristics; Clinical; Clinical Trials; Computer Simulation; Cyclotrons; Dementia; Diagnosis; Documentation; Dose; Fluorine; Furuncles; Generations; Goals; Grant; Heating; Image; Injection of therapeutic agent; Intellectual Property; Ions; Label; Laboratories; Legal patent; Magnetic Resonance Imaging; Malignant Neoplasms; Mediation; Medical; Medicare; Metabolic; Methods; Modeling; Modification; Neurologic; Nuclear Reactors; Ownership; PET/CT scan; Patient Care; Patients; Performance; Pharmacy Distributions; Pharmacy facility; Phase; Positron-Emission Tomography; Procedures; Production; Protons; Public Health; Pump; Radioisotopes; Radiopharmaceuticals; Running; Site; Small Business Innovation Research Grant; Solutions; Source; System; Techniques; Technology; Testing; Therapy Evaluation; Time; abstracting; base; bone; commercialization; cost; cost effective; design; experience; heat exchanger; imaging modality; ion source; model design; new technology; prototype; public health relevance; radiotracer; regenerative; repaired; research and development; research clinical testing; single photon emission computed tomography; treatment planning

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.

描述(由申请人提供)：回旋加速器生产的[18F]氟代脱氧葡萄糖(FDG)广泛用于临床PET/CT，用于许多癌症和阿尔茨海默氏症的医疗保险批准的诊断和治疗评估。回旋加速器药房配送中心与FDG成像的年增长保持同步，FDG的基础是代谢(与CT和MRI的解剖成像不同)。然而，最近预测，除FDG外，对18F放射性药物的需求在未来2-4年内将大幅增加，需求将扩大5-10倍。许多99mTcSPECT放射性药物依赖于99mMo发生器(来自核反应堆)的洗脱，已经使用了几十年。今天，由于几个老化的反应堆(都不是美国的)需要长时间停工维修，全球出现了反应堆生产的医用放射性核素短缺。为了取代衰弱的放射性药物，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。其中许多放射性示踪剂正在进行临床试验，预计将在未来3-6年内获准报销。安装更多使用内部潘宁离子源(束流限制在100-150微安)的主要11-18 MeV负离子回旋加速器，并不是大幅提高产量的最有效的商业模式。一种新构思的、明显优越的方法是利用注入离子源实现更大的回旋加速器，允许束流功率提高5倍，从而提供更多种类的放射性药物和更大的患者剂量体积。与更大的集中式回旋加速器药房相关的成本比同等的5-6个较小的回旋加速器要低得多。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更高的能量消耗的目标。申请人于2007年底完成的两项第二阶段SBIR赠款确定所需的新技术是可行的，该阶段研究了热虹吸管沸腾目标(2-6千瓦)和非沸腾再循环目标(5-20千瓦)。拟议项目的目标是完成研发，以实施支持基于更大的集中式回旋加速器的新商业模式的原型目标，及时为2013年年中的商业实施做好准备。到那时，大多数现有的小型回旋加速器将达到满负荷，而较大的回旋加速器方案，战略性地放置在现有的较小回旋加速器中间，是满足18F产量增加的预期需求的最有效方式。 公共卫生相关性：阿尔茨海默氏症、心血管疾病和癌症是日益严重的公共卫生问题。PET/CT诊断和治疗计划对确定最有效的患者护理过程有着深远的影响。氟-18标记的放射性药物是这种成像方式最重要的试剂。该项目的总体目标是通过开发经济、大规模的氟-18放射性核素回旋加速器生产方法，显著提高氟-18标记放射性药物的可用性。

项目成果

Simulation, design, and testing of a high power collimator for the RDS-112 cyclotron.

RDS-112 回旋加速器高功率准直器的仿真、设计和测试。

• DOI: 10.1016/j.apradiso.2014.12.028
• 发表时间: 2015
• 期刊: Applied radiation and isotopes : including data, instrumentation and methods for use in agriculture, industry and medicine
• 作者: Peeples,JohannaL;Stokely,MatthewH;Poorman,MichaelC;Bida,GeraldT;Wieland,BruceW
• 通讯作者: Wieland,BruceW