Lantheus Medical Imaging, formerly Bristol-Myers Squibb Medical Imaging, has initiated a multicenter Phase IV observational study to evaluate the safety profile of Definity Vial for injectable suspension in patients with suboptimal echocardiograms and provide safety information on the use of ultrasound contrast agents in routine clinical practice.
The open-label, non-randomized CaRES (Contrast Echocardiography REgistry for Safety Surveillance) registry will be conducted in at least 10 clinical sites in the U.S. and include at least 1,600 patients, the North Billerica, Mass.-based Lantheus said.
The company said its study will gather data on patient characteristics and demographics, indication for the contrast usage, safety monitoring of patients during and after Definity administration, as well as the nature and frequency of any adverse events that may occur.
In last quarter of 2007, the FDA added a black box warning to Definity, due to reports of “deaths and serious cardiopulmonary reactions,” according to the agency. However, presenters at ACC08 said that the FDA should reconsider a strong warning it issued on ultrasound contrast agents based on their study results.
“The CaRES registry was established following discussions with the FDA to further explore the safety profile of Definity as it is used in clinical practice. We believe this is the first large multi-center safety registry of its kind to be performed in the U.S.,” said Mark Hibberd, MD, senior medical director at Lantheus. “We expect the study to provide the physician community with important information about the safety profile of Definity in patients with suboptimal non-contrast echo studies.”