Lantheus Medical Imaging Releases Preliminary Results from Phase 3 Clinical Trial of Flurpiridaz F 18 for the Detection of Coronary Artery Disease
10/30/2013 7:25:45 AM
NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Lantheus Medical Imaging, Inc., a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents, today announced preliminary results from the first of two planned Phase 3 trials to assess the diagnostic efficacy of flurpiridaz F 18, an imaging agent used in Positron Emission Tomography (PET) myocardial perfusion imaging (MPI) for the detection of coronary artery disease (CAD). The trial compared PET MPI with flurpiridaz F18 to single photon emission computed tomography (SPECT) MPI, the current standard of care, using invasive coronary angiography as the truth standard. The open-label, multicenter study had two co-primary endpoints: superiority in sensitivity (identifying disease) and non-inferiority in specificity (ruling out disease). Flurpiridaz F 18 outperformed SPECT in a highly statistically significant manner in sensitivity and showed a statistical trend towards improved diagnostic accuracy. However, flurpiridaz F 18 did not meet the non-inferiority criterion for identifying subjects without disease.
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