Safety and effectiveness of single- versus triple-dose gadodiamide injection- enhanced MR angiography of the abdomen: a phase III double-blind multicenter study.

PURPOSE: To evaluate the safety and effectiveness of gadodiamide-enhanced magnetic resonance (MR) angiography with single and triple doses in the assessment of abdominal arterial stenoses. MATERIALS AND METHODS: One hundred five patients were included in the randomized, double-blind, phase III multicenter trial. Results of MR angiography with 0.1 mmol/kg and 0.3 mmol/kg doses of gadodiamide were compared with those of digital subtraction angiography (DSA) and according to dose. RESULTS: No serious adverse events were observed. The mean contrast index at the region proximal to the primary stenosis was significantly higher in the triple-dose group (P = .03). Mean 95% CI values for the difference in depicted degree of stenosis between DSA and postcontrast MR angiography improved from −3.4% ± 4.7 (SD) in the single-dose group to −1.2% ± 4.7 in the triple-dose group. Mean values for overall image quality on the visual analogue scale improved with the triple dose (P = .02). Confidence in diagnosis was high at p...