Perflenapent emulsion: a US contrast agent for diagnostic radiology--multicenter, double-blind comparison with a placebo. EchoGen Contrast Ultrasound Study Group.
OBJECTIVE
To evaluate perflenapent emulsion as a contrast agent for ultrasound (US) of the liver, kidneys, and vasculature.


METHODS
A randomized, double-blind, placebo-controlled, multicenter trial of 151 patients was performed. Investigators and blinded readers compared sonograms obtained after intravenous administration of perflenapent emulsion (0.05 mL/kg) and of a placebo with baseline sonograms.


RESULTS
Contrast enhancement occurred in 140 of 149 patients (94%) after perflenapent administration and in 12 patients (8%) after placebo administration (P < .001). Enhancement lasted 5.0-15.4 minutes with perflenapent and 0.1-1.7 minutes with the placebo (P < .001). Perflenapent enhanced or facilitated visualization of blood flow, abnormal structures, masses, and lesions in 138 of 147 patients (94%) versus 12 of 147 (8%) for the placebo (P < .001). Improved visualization assisted in the diagnosis in 105 of 143 perflenapent studies (73%) compared with five of 143 placebo studies (3%) (P < .001). Diagnostic information affected case management in 71 of 148 patients (48%) after perflenapent administration and in nine of 148 patients (6%) after placebo administration (P < .001). Adverse effects associated with perflenapent were few and mostly mild, occurred within 30 minutes, and resolved without treatment.


CONCLUSIONS
Perflenapent emulsion is a safe and effective contrast agent for US of the liver, kidneys, and vasculature.
Robbin
M L
ML
Department of Radiology, University of Alabama, Birmingham 35233-1924, USA.
Eisenfeld
A J
AJ
D000328:Adult; D003287:Contrast Media / Q000009:adverse effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004655:Emulsions; D005466:Fluorocarbons / Q000009:adverse effects; D006801:Humans; D010919:Placebos; D012449:Safety; D014463:Ultrasonography / Q000379:methods* / Q000706:statistics & numerical data; D014481:United States; D010420:Pentanes
D003287:Contrast Media; D004655:Emulsions; D005466:Fluorocarbons; D010919:Placebos; C008806:perfluoropentane; D010420:Pentanes