“An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)”
This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.
Drug - PET MPI
Flurpiridaz (18F) Injection. All subjects will receive 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein: 1 at rest and 1 during stress. The dosages of Flurpiridaz (18F) Injection administered at rest and during stress conditions will not exceed a total of 14 mCi (520 MBq) for an individual subject.
Drug - SPECT MPI
SPECT imaging must use 99mTc-based myocardial tracers. SPECT agents utilised for the purposes of this clinical study will be administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards, where applicable. All patients will undergo SPECT MPI.
Drug - Pharmacological stress agents
Pharmacologic stress agents will be restricted to the following 3 agents, as permitted by local marketing authorisations and availability: adenosine, dipyridamole, and regadenoson. Administration will be through an IV line.
A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease