DEVELOPMENT OF A COPPER 62 PET PERFUSION AGENT

正电子发射断层扫描（PET）是一种功能强大的诊断成像 区域组织非侵入性评估技术 病理生理学不幸的是，PET的广泛临床应用 目前受到高成本和复杂监管问题的限制 与回旋加速器正电子发射的生产有关 放射性药物该项目的主要目标是 发电机基铜-62的商业开发 放射性药物，似乎有希望与PET临床使用。 62 Cu-n-PrTS和62 Cu-ETS放射性药物将继续在 作为心肌灌注的示踪剂进行评价;而最终测试 继续进行模块化62 Zn/62 Cu发生器系统配置为 放射性药物合成和输送线。 对于那个 在临床前研究、数据和支持方面表现最佳 将收集文件，以创建药物主文件， 新药（IND）的研究豁免声明通知。 使用选定的62 Cu的I期和II期临床试验- 放射性药物将在项目的第2年开始。 并发 合成研究将致力于拓宽 62 Cu-可用于临床的药剂。 成功 这些62 Cu放射性药物的商业开发将 促进PET技术在诊断中的经济应用 冠状动脉疾病患者的评估。 建议的商业应用：该项目旨在开发 有前途的新的62 Cu放射性药物，用于与 Proportional Technologies模块化62 Zn/62 Cu发生器系统。的 集成的62 Cu发生器和放射性药物输送系统， 适用于全国范围内的交付，预计将大大 降低与正电子发射的诊断使用相关的成本 断层扫描（PET）在组织灌注评价中的应用。

Positron emission tomography (PET) is a powerful diagnostic imaging technique for non-invasive assessment of regional tissue pathophysiology. Unfortunately, widespread clinical application of PET is currently limited by the high cost and complex regulatory issues associated with production of cyclotron-based positron-emitting radiopharmaceuticals. The principal objective of this project is the commercial development of generator-based copper-62 radiopharmaceuticals that appear promising for clinical use with PET. The 62Cu-n-PrTS and 62Cu-ETS radiopharmaceuticals will continue to be evaluated as tracers for myocardial perfusion; while final testing continues on a modular 62Zn/62Cu generator system configured for on- line radiopharmaceutical synthesis and delivery. For the agent that performs best in pre-clinical studies, data and supporting documentation will be assembled for creation of a Drug Master File and a Notice of Claimed Investigational Exemption for a New Drug (IND). Phase I and Phase II clinical trials with the selected 62Cu- radiopharmaceutical will begin in Year 2 of the project. Concurrent synthetic research will be directed towards broadening the spectrum of 62Cu-agents that can be delivered for clinical use. Successful commercial development of these 62Cu-radiopharmaceuticals would facilitate economical application of PET technology in the diagnostic evaluation of patients with coronary artery disease. PROPOSED COMMERCIAL APPLICATION: This project seeks to develop promising new 62Cu-radiopharmaceuticals for use in conjunction with the Proportional Technologies modular 62Zn/62Cu generator system. The integrated 62Cu-generator and radiopharmaceutical delivery system is suitable for nationwide delivery and is expected to substantially reduce the cost associated with diagnostic use of positron emission tomography (PET) in evaluation of tissue perfusion.