Lantheus Medical Imaging announced the initiation of the first of two phase III clinical trials to assess myocardial perfusion using positron emission tomography (PET) imaging with flurpiridaz F 18 in patients with suspected or known coronary artery disease.
The study will evaluate the diagnostic efficacy of flurpiridaz F 18 PET myocardial perfusion imaging (MPI), compared with single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease. The phase III clinical development programme will include two open-label trials in approximately 1,350 patients at approximately 100 clinical trial sites worldwide, including locations in the USA, Canada, Europe and South America.
Don Kiepert, president and CEO of Lantheus Medical Imaging, commented, “There is a significant need for improved non-invasive imaging tools to help physicians better evaluate and manage patients with cardiovascular disease. Clinical trial results to date show that PET with flurpiridaz F 18 can improve diagnostic performance compared to SPECT and we anticipate that the results from our phase III clinical programme will confirm the findings seen in previous studies, reinforcing the diagnostic efficacy of PET imaging for evaluating coronary artery disease.”
The first phase III clinical trial is an open-label, international multicentre study of flurpiridaz F 18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for invasive coronary angiography.
The trial will enrol approximately 680 patients. The primary objective of the study is to assess the diagnostic efficacy (sensitivity and specificity) of flurpiridaz F 18 PET MPI compared to SPECT MPI in the detection of significant coronary artery disease or a documented history of myocardial infarction. Secondary endpoints include the localisation of significant coronary artery disease, identification of multi-vessel coronary artery disease, and the evaluation of image quality, diagnostic certainty, and reversible defect size with flurpiridaz F 18 PET MPI compared to SPECT MPI. Three independent, blinded readers will assess the PET rest and stress images as well as the SPECT rest and stress images for each patient.
“SPECT imaging has a number of challenges, including sub-optimal image quality, underestimation of ischaemia, low sensitivity for multi-vessel coronary artery disease, and artifacts that result in false positive test results,” said Jamshid Maddahi, professor of molecular and medical pharmacology (Nuclear Medicine) and medicine (cardiology) at the David Geffen School of Medicine at UCLA and lead investigator of the study. “PET MPI has the potential to reduce the number of patients sent to cardiac catheterisation unnecessarily, improve the identification of patients with risky multi-vessel disease, and reduce redundant downstream testing due to non-definitive results.”
Lantheus presented phase II study results for flurpiridaz F 18 at the International Conference on Nuclear Cardiology and Cardiac CT (ICNC10) in May in Amsterdam and at the SNM (Society of Nuclear Medicine) 58th Annual Meeting in June in San Antonio, USA. The findings demonstrated PET myocardial perfusion imaging with flurpiridaz F 18 provided superior image quality, diagnostic certainty, and diagnostic performance for detecting coronary artery disease compared to SPECT MPI, the current standard for the non-invasive detection of coronary artery disease. The data also demonstrated a strong safety profile for PET imaging with flurpiridaz F 18.
The Phase 3 clinical programme has received a Special Protocol Assessment from the FDA. For more information about the flurpiridaz F 18 clinical trial, please click here.