Lantheus Medical Imaging, a diagnostic imaging provider, has reached agreement with the US Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design and planned analysis of a Phase 3 clinical trial.
The trial is designed for the assessment of myocardial perfusion using Positron Emission Tomography (PET) imaging of flurpiridaz F-18 in patients with suspected or known coronary artery disease (CAD).
The Phase 3 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 US, 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.
Lantheus Medical Imaging president and CEO Don Kiepert said the SPA agreement is a milestone in the development of flurpiridaz F-18 and provide with a clearly defined path forward for the Phase 3 program.
"We believe that flurpiridaz F-18 can improve the diagnosis and evaluation of coronary artery disease, ultimately reducing the need for additional medical tests and procedures," Kiepert said.