MR Angiography with Gadofosveset Trisodium for Peripheral Vascular Disease: Phase II Trial

PURPOSE: To evaluate the dose response and safety of gadofosveset trisodium–enhanced magnetic resonance (MR) angiography compared with nonenhanced two-dimensional time-of-flight MR angiography and with x-ray angiography as the standard. MATERIALS AND METHODS: In this randomized, 20-center, double-blind study, 238 men and women who had peripheral vascular disease or were suspected of having it received intravenous injection of placebo or gadofosveset (0.005, 0.01, 0.03, 0.05, or 0.07 mmol per kilogram of body weight). MR angiographic images were evaluated by three blinded readers, and x-ray angiographic images were evaluated by two readers. Hypothesis testing for the presence of a dose response was based on a linear test for trend for increase in area under the receiver operating characteristic curve as a function of dose for each reader of MR angiographic images independently. RESULTS: Gadofosveset administration resulted in a dose-dependent increase in diagnostic accuracy for detection of aortoiliac occl...