Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announced data from a Phase 2 clinical trial that demonstrated Positron Emission Tomography (PET) myocardial perfusion imaging with flurpiridaz F 18 provided superior image quality, diagnostic certainty and diagnostic performance for detecting coronary artery disease (CAD) compared to single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI), the current standard for the non-invasive detection of CAD. The data also demonstrated a positive safety profile for PET imaging with flurpiridaz F 18. The data were featured today in a late-breaking presentation by Jamshid Maddahi, M.D., F.A.C.C., Professor of Molecular and Medical Pharmacology (Nuclear Medicine) and Medicine (Cardiology) at the David Geffen School of Medicine at UCLA, and Lead Principal Investigator of the study, at ICNC10 - Nuclear Cardiology and Cardiac CT Conference in Amsterdam.
"Results from this Phase 2 trial show that PET myocardial perfusion imaging with flurpiridaz F 18 demonstrate a strong safety profile and is superior to SPECT imaging with respect to the quality of rest and stress images, certainty of image interpretation, and diagnostic performance as measured by standard ROC analysis for detecting CAD," said Dr. Maddahi. "Overall, this enhanced diagnostic performance may lead to more accurate testing and more appropriate patient management decisions in comparison to other non-invasive diagnostic modalities and, as such, we see great value in proceeding to Phase 3 clinical trials."
In the Phase 2 trial, 143 patients from 21 centers underwent rest and stress PET and SPECT myocardial perfusion imaging and were evaluated for safety. Of these patients, 86 underwent coronary angiography and formed the population for evaluating diagnostic performance. PET myocardial perfusion imaging was performed with flurpiridaz F 18 at rest and at stress utilizing pharmacological coronary vasodilation or treadmill exercise. It is important to note that flurpiridaz F 18 can be used in conjunction with treadmill exercise, which is not feasible with more commonly used alternative PET tracers for myocardial perfusion imaging.
Results showed that a significantly higher percentage of images were rated as either excellent or good quality with PET imaging, compared to SPECT imaging for stress images (98.8% vs. 84.9%, p<0.01) and rest images (95.3% vs. 69.8%, p<0.01). Diagnostic certainty of interpretation (the percentage of cases with definitely abnormal or definitely normal interpretation) was significantly higher for PET compared to SPECT (90.7% vs. 75.6%, P<0.01). The area under the ROC curve for CAD diagnosis was significantly higher for PET than SPECT (0.82±0.05 vs. 0.70±0.05, p<0.05). Sensitivity with PET imaging was significantly higher than SPECT (78.8% vs. 61.5%)
"The Phase 2 trial of PET imaging with flurpiridaz F 18 met all study objectives and we are very pleased with the study findings, which show a trend toward improved diagnostic performance compared to SPECT MPI for the detection of CAD," said Dana S. Washburn, M.D., Vice President, Clinical Development and Medical Affairs at Lantheus Medical Imaging. "PET imaging has gained considerable support in the field of cardiovascular imaging, as it offers many advantages to SPECT imaging. Flurpiridaz F 18 shows great promise as a novel PET myocardial perfusion imaging tool and we look forward to initiating our Phase 3 clinical development program of flurpiridaz F 18 in the second quarter of this year."
In March 2011, Lantheus received Special Protocol Assessment approval from the FDA for the Phase 3 trial of flurpiridaz F 18. The Phase 3 clinical development program will include two open-label, multicenter trials to assess the diagnostic efficacy (both sensitivity and specificity) of flurpiridaz F 18 PET MPI, compared with SPECT myocardial perfusion imaging in the detection of significant coronary artery disease. The trials will enroll a total of approximately 1,350 patients at approximately 100 sites globally. Coronary angiography will be the truth standard for all patients. The clinical development program includes hypotheses for superiority for sensitivity and non-inferiority for specificity with an adequate sample size to demonstrate superior specificity if present. An interim analysis will take place upon 50 percent enrollment of the first trial.
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