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。早期诊断冠心病的能力 多年来有所改善，从而降低了死亡率。在核能领域 医学/心脏病学、SPECT和PET心肌灌注成像(MPI) 在过去10年中临床使用的方法和放射性药物 提供了可接受的准确性和诊断结果，但现在已达到 改进的限度。这项研究项目将使用一种令人兴奋的新PET MPI 名为F-18flurpiridaz的示踪剂目前已进入FDA第三阶段 临床试验。这种新的PET示踪剂提供了更高的空间和对比度分辨率 超过SPECT MPI，提供更高的时间分辨率和更长的半衰期 目前的PET示踪剂使其成为评估患者的理想MPI示踪剂 疑似冠心病患者。这笔SBIR赠款的长期目标是开发一种 心肌相对定量和绝对定量的定量方法 灌注、心功能和心肌血流量(MBF)，使用新的 PET MPI示踪剂，F-18标记的氟吡啶。这些结果最终将是 整合到商业上可用的诊断工具中供临床使用。这 SBIR第一阶段建议书将用来证明 研究并开发了一种定量分析方法的原型 氟派立达PET图像。第一阶段的具体目标将是1)开发和 验证心肌血流量绝对定量的模型，2)开发 绝对和相对MBF的定量正常数据库，3)验证和 优化缺陷大小和缺陷可逆性的相对定量，以及4) F-18相对和绝对F-18氟吡啶PET诊断价值的评价 定量检测冠心病。第一阶段的完成将产生一个 Furpiridaz PET MPI分析的原型定量应用 在第一阶段成功完成后，我们将提交第二阶段 向美国国立卫生研究院提出建议。这一阶段的研究将包括开发新的 氟吡啶示踪剂的定量参数及广泛应用前景 在一个更大的数据库中对第一阶段项目进行验证 FDA氟哌达的第三阶段临床试验。第二阶段结束时的交付成果将 成为氟吡啶综合分析的定量医疗仪器 宠物形象。该系统将利用Syntermed的成功进行商业化 战略通过：1)授权给主要仪器制造商，2)直接 销售给使用PC工作站的客户，以及3)使用 现有的SynTerm 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.