Positive Phase III results with flurpiridaz F-18 in PET imaging of CAD- Lantheus Medical Imaging

Lantheus Medical Imaging has announced that results from its first Phase III study of flurpiridaz F 18 for myocardial perfusion imaging (MPI) which confirm the value of this novel agent as compared with standard SPECT imaging for the diagnosis of coronary artery disease. Subjects underwent flurpiridaz F 18 PET MPI and SPECT MPI studies, with coronary angiography used as the truth standard for each.

The currently available PET MPI agents do not generally allow sufficient time for exercise stress testing and are thus limited to pharmacological stress testing. With a 110 minute half life, flurpiridaz F 18 can be easily used in association with treadmill exercise stress testing, which in itself can give a clinician valuable observational data about a patient's condition to complement the imaging results. The study showed that in a well-controlled setting, flurpiridaz F 18 imaging consistently performed in a balanced manner in identifying disease (sensitivity) and ruling out disease (specificity) when compared to coronary angiography. Unlike flurpiridaz F 18, SPECT imaging results were skewed with low sensitivity and high specificity.

The study's two pre-specified primary endpoints required a comparison of the balanced flurpiridaz F 18 sensitivity and specificity results and the skewed SPECT sensitivity and specificity results. In this comparison, flurpiridaz F 18 far exceeded SPECT for sensitivity but did not meet the non-inferiority threshold for specificity, implying a substantial and unexpected under-diagnosis of CAD with SPECT imaging in the trial. Importantly, radiation exposure associated with flurpiridaz F 18 imaging was reduced to approximately 50% of that associated with SPECT MPI. Data were presented at the International Conference on Nuclear Cardiology and Cardiac CT.