Lantheus Medical Imaging has reached an agreement with the FDA regarding a special protocol assessment (SPA) on the design and planned analysis of a phase III clinical trial for the assessment of myocardial perfusion using PET imaging of flurpiridaz F-18 in patients with suspected or known coronary artery disease (CAD).
The North Billerica, Mass.-based company plans to initiate the first of two planned phase III trials in the second quarter.
Flurpiridaz F-18 has completed a phase II clinical trial, and analysis of the full data set will be presented at ICNC10 - Nuclear Cardiology and Cardiac CT conference, scheduled for May 15-18 in Amsterdam, Netherlands, according to Lantheus. Preliminary phase II data were presented at the annual meeting of the Society of Nuclear Medicine (SNM) in June 2010.
The phase III clinical development program will include two open-label trials designed to assess myocardial perfusion using PET imaging of flurpiridaz F-18 in approximately 1,350 patients with suspected or known CAD at approximately 100 clinical trial sites, including locations in the U.S., Canada, Europe and South America. The primary objective of the study will be to assess the diagnostic efficacy (sensitivity and specificity) of flurpiridaz F-18 injection PET myocardial perfusion imaging (MPI), compared with SPECT MPI in the detection of significant coronary artery disease.