Study Will Evaluate DEFINITY in Patients With Suboptimal Echocardiograms
May 28, 2009 – Lantheus Medical Imaging Inc. today said it completed patient enrollment of CaRES (Contrast Echocardiography REgistry for Safety Surveillance), the first, multicenter phase IV observational registry that evaluates the use of ultrasound imaging agents in routine clinical practice.
The 1,060 patients who were enrolled at 15 sites in the U.S. were age 18 or older and required DEFINITY Vial for (Perflutren Lipid Microsphere) injectable suspension-enhanced echocardiography because of a previous suboptimal, unenhanced echocardiogram.
The company said the study will provide important clinical information about the use of DEFINITY in a range of patient types and clinical settings. The CaRES registry was established following discussions with the FDA to further explore the clinical use of DEFINITY. The prospective, open-label, nonrandomized, surveillance registry will gather and analyze data on patient demographics and characteristics, reasons for using DEFINITY, results of safety monitoring, and the nature and frequency of any adverse events.
Since DEFINITY received approval for use in the U.S., approximately 2 million doses have been administered to patients with suboptimal echocardiograms to see the borders of the heart more clearly.
Up to 20 percent of resting echocardiography studies will result in suboptimal echocardiograms, Lantheus said. A suboptimal image is one in which at least two out of six myocardial segments of the left ventricle cannot be visualized appropriately, as defined by the American Society of Echocardiography (ASE). The use of contrast in suboptimal echocardiograms may help with clinical evaluation of the patient.
For more information: www.lantheus.com