GE Healthcare launches trial for PET imaging agent
GE Healthcare and Lantheus Holdings, Inc., parent company of Lantheus Medical Imaging, Inc., have started a second Phase 3 clinical trial of Flurpiridaz 18F (called the AURORA study), an investigational agent bein g evaluated for the detection of coronary artery disease (CAD), the most common form of heart disease. The AURORA study is an international, multicenter study to evaluate diagnostic efficacy of Flurpiridaz 18F Injection positron-emission tomography (PET) myocardial perfusion imaging (MPI) in the detection of CAD. In this prospective, open-label, study, patients with suspected CAD, for whom an intracoronary angiography (ICA) has been indicated, will undergo a single-photon emission computed tomography (SPECT) MPI and Flurpiridaz 18F Injection PET MPI prior to the performance of coronary angiography. The primary endpoint is the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz 18F Injection PET MPI for the detection of significant CAD.