BENEFIT 1 LVEF is a Phase 3, open-label, multicentre clinical trial designed to evaluate the LVEF measurement accuracy and reproducibility of DEFINITY
DEFINITY is an ultrasound contrast agent used in suboptimal echocardiograms. (Credit: Pixabay/Luan Luan Rezende.)
Lantheus, the parent organisation of diagnostic imaging firm Lantheus Medical Imaging (LMI), has unveiled results from the BENEFIT 1 Left Ventricular Ejection Fraction (LVEF) clinical trial.
BENEFIT 1 LVEF is a Phase 3, open-label, multicentre clinical trial designed to evaluate the LVEF measurement accuracy and reproducibility of DEFINITY contrast-enhanced and unenhanced echocardiography compared to non-contrast cardiac magnetic resonance imaging (CMRI).
Lantheus president and chief executive officer Mary Anne Heino said: “DEFINITY is the worldwide leading product in the ultrasound contrast market and it remains a proven and preferred imaging agent serving the echocardiography community within its current indication.
“We are disappointed with the outcome of the BENEFIT 1 trial but we remain fully confident in DEFINITY and the long term growth potential of our microbubble franchise. We will continue to interact with the FDA to enhance the clinical utility for DEFINITY moving forward.”
DEFINITY is an ultrasound contrast agent used in suboptimal echocardiograms
The primary objective of this clinical trial, which enrolled 145 subjects, was to demonstrate improvement in accuracy in measuring LVEF using DEFINITY contrast-enhanced over unenhanced echocardiography as compared to LVEF measured using CMRI.
The DEFINITY Vial for Injectable Suspension, which produces durable microbubbles to facilitate evaluation of the left ventricle, has been developed as an ultrasound contrast agent for use in with suboptimal echocardiograms.
The company said that the trial did not show considerable improvement in the accuracy of LVEF values for contrast-enhanced echocardiography versus unenhanced echocardiography when compared to CMRI.
However, a post-hoc analysis demonstrated improvement in left ventricular diastolic, systolic and stroke volume measurements with contrast-enhanced versus unenhanced echocardiography, compared to CMRI.
Lantheus chief medical officer Istvan Molnar said: “Although the endpoints for BENEFIT 1 were not met, we will continue to analyze the BENEFIT 1 data. When the data from BENEFIT 2 are available, we will compile the data sets to analyze the full results of the trials. We are grateful to the patients, investigators, and trial sites for participating in this trial.”