Clinical trials to study the efficacy of a novel cardiac viability imaging agent is now underway. FluoroPharma, Inc., an affiliate of QuantRx Biomedical Corp., has developed CardioPET as a means to assess acute and chronic coronary artery disease while patients are at rest.
Entry into Phase I trials follows FluoroPharma's filing with the FDA of an investigational new drug (IND) application for CardioPET, the company's first such application.
The single-center, open-label study is designed to evaluate safety, distribution and dosimetry of CardioPET as a positron emission tomography (PET) tracer for myocardial imaging in healthy subjects. Study leader Alan J. Fischman, M.D., is director of the Nuclear Medicine Division of Massachusetts General Hospital and a highly respected leader in PET uses and techniques.