FluoroPharma将开展新型PET造影剂的I期临床试验

 
 
一种目前正在研发的新型心脏功能造影剂，能够帮助患者在静息状态下评估急性和慢性冠状动脉疾病。

FluoroPharma公司(Boston, MA, USA)已经宣布开始I期临床试验，评估该公司的新型正电子发射扫描成像(PET)造影剂CardioPET，此项临床试验已经得到了学术评估委员会(IRB)的批准。I期临床试验是单中心、开放标签的临床研究，主要是在健康受试者中评估CardioPET作为心肌成像示踪剂的安全性、体内分布和放射剂量。

这项研究是由Alan Fischman医生主持的，他是美国麻省总医院(MGH; Boston, MA, USA)核医学科的主任。在2006年5月，FluoroPharma公司为CardioPET进行了了新药研制申请(IND)，这是该公司的第一项IND。

 
PET Contrast Agent Images Cardiac Patients at Rest
 
A new cardiac viability imaging agent currently in development allows acute and chronic coronary artery disease to be assessed while patients are at rest.

FluoroPharma, Inc. (Boston, MA, USA), has announced the start of phase I clinical trials for its new positron emission tomography (PET) agent, CardioPET, following institutional review board (IRB) approval of the proposed studies. The phase I trial is a single center, open label study, designed to evaluate safety, distribution, and dosimetry of CardioPET as a PET tracer for myocardial imaging in healthy subjects.

The study will be led by Dr. Alan Fischman, director of the nuclear medicine division at Massachusetts General Hospital (MGH; Boston, MA, USA). In May 2006, FluoroPharma filed an Investigational New Drug (IND) application for CardioPET, which is the company’s first IND.