Myocardial blood flow quantitation with the novel F-18 Flurpiridaz PET imaging tr

冠状动脉疾病仍然是导致死亡的主要原因 在美国早期诊断CAD患者的能力 多年来，这一状况得到改善，导致死亡率下降。核 医学/心脏病学，SPECT和PET心肌灌注成像（MPI） 在过去的10年里，临床上使用的方法和放射性药物 在准确性和诊断方面提供了可接受的结果，但现在已经达到了 改善的限度。该研究项目将使用令人兴奋的新型PET MPI 一种名为F-18氟比达兹的示踪剂，目前正处于FDA第三阶段的一半。 临床试验这种新的PET示踪剂提供更高的空间和对比度分辨率 并提供更高的时间分辨率和更长的半衰期， 目前的PET示踪剂使其成为评价患者的理想MPI示踪剂 疑似CAD这项SBIR赠款的长期目标是开发一个 心肌细胞相对和绝对定量的定量方法 灌注，心室功能和心肌血流量（MBF），使用新的 PET MPI示踪剂，F-18标记的氟吡达。这些结果最终将 结合到市售的诊断工具中用于临床使用。这 SBIR第一阶段提案将用于证明 研究并开发了一个原型的定量分析方法， flurpiridaz PET图像。第一阶段的具体目标是：1）发展和 验证心肌血流量绝对定量模型，2）开发 绝对和相对MBF的定量正常数据库，3）验证和 优化缺陷尺寸和缺陷可逆性的相对定量，以及4） 评价相对和绝对F-18氟比哒嗪PET的诊断价值 用于检测CAD的定量。第一阶段完成后， 用于分析氟吡哒唑PET MPI的原型定量应用。 在第一阶段成功完成后，我们将提交第二阶段报告， 向NIH提出建议。这一阶段的研究将包括开发新的 氟比哒唑示踪剂的定量参数和广泛的前景 第一阶段项目在一个更大的数据库中得到验证， 三期FDA flurpiridaz临床试验。第二阶段结束时的交付品将 是一种全面分析氟啶达的定量医疗装置， PET图像。该系统将利用Syntermed的成功 战略通过：1）许可给主要仪器制造商，2）直接 销售给使用PC工作站的客户，以及3）使用 现有的Syntermed Live网络。

Coronary artery disease continues to be a major contributor to the cause of death in the United States. The ability to diagnosis CAD in patients at an early stage has improved over the years resulting in reducing the mortality rate. In nuclear medicine/cardiology, the SPECT and PET myocardial perfusion imaging (MPI) methods and radiopharmaceuticals used clinically over the past 10 years have offered acceptable results for accuracy and diagnosis but have now reached their limit for improvement. This research project will use an exciting new PET MPI tracer called F-18 flurpiridaz which is currently half way through phase III FDA clinical trials. This new PET tracer offers higher spatial and contrast resolution over SPECT MPI and offers higher temporal resolution and longer half life over current PET tracers making it the ideal MPI tracer for the evaluation of patients with suspected CAD. The long-term objective of this SBIR grant is to develop a quantitative method for the relative and absolute quantitation of myocardial perfusion, ventricular function, and myocardial blood flow (MBF), using the new PET MPI tracer, F-18 labeled flurpiridaz. These results will ultimately be incorporated into a commercially available diagnostic tool for clinical use. This SBIR phase I proposal will be used to demonstrate a proof-in-principle of the research and to develop a prototype of the quantitative method for analysis of flurpiridaz PET images. The specific aims for phase I will be 1) to develop and validate a model for absolute quantitation of myocardial blood flow, 2) to develop quantitative normal databases for absolute and relative MBF, 3) to validate and optimize relative quantitation for sizing of defect and defect reversibility, and 4) to evaluate the diagnostic values of relative and absolute F-18 flurpiridaz PET quantitation for detection of CAD. The completion of phase I will produce a prototype quantitative application for the analysis of the flurpiridaz PET MPI. Following the successful completion of phase I, we will submit a phase II proposal to NIH. The research in this phase will include development of new quantitative parameters for the flurpiridaz tracer and an extensive prospective validation of the phase I projects in a much larger database obtained from the phase III FDA flurpiridaz clinical trials. The deliverable at the end of phase II will be a quantitative medical device for the comprehensive analysis of flurpiridaz PET images. The system will be commercialized using Syntermed's successful strategy through: 1) licensing to major instrumentation manufacturers, 2) direct sales to clients that use PC workstations and 3) per Web-access using the existing Syntermed Live network.