PERFLENAPENT EMULSION - A US CONTRAST AGENT FOR DIAGNOSTIC RADIOLOGY-MULTICENTER, DOUBLE-BLIND COMPARISON WITH A PLACEBO

PURPOSE: To evaluate perflenapent emulsion as a contrast agent for ult rasound (US) of the liver, kidneys, and vasculature. MATERIALS AND MET HODS: A randomized, double-blind, placebo-controlled multicenter trial of 151 patients was performed. Investigators and blinded readers comp ared sonograms obtained after intravenous administration of perflenape nt emulsion (0.05 mL/kg) and of a placebo with baseline sonograms. RES ULTS: Contrast enhancement occurred in 140 of 149 patients (94%) after perflenapent administration and in 12 patients (8%) after placebo adm inistration (P < .001). Enhancement lasted 5.0-15.4 minutes with perfl enapent and 0.1-1.7 minutes with the placebo (P < .001). Perflenapent enhanced of facilitated visualization of blood flow, abnormal structur es, masses, and lesions in 138 of 147 patients (94%) versus 12 of 147 (8%) for the placebo (P < .001). Diagnostic information affected case management in 71 of 148 patients (48%) after perflenapent administrati on and in nine of 148 patients (6%) after placebo administration (P < .001). Adverse effects associated with perflenapent were few and mostl y mild, occurred within 30 minutes, and resolved without treatment. CO NCLUSION: Perflenapent emulsion is a safe and effective contrast agent for US of the liver, kidneys, and vasculature.