• Thomas Kittner, Jens Rudolf, Joan Falco Fages, Paul Legmann, Manuela Aschauer, Imre Repa, Marta Rodriguez Alvares, Ibone Savalegui, Harald Ittrich, Kjell Geterud, Eric de Kevviler, Juan Ayuso, Mark E Lockhart, Alain Blum, Herbert Iliasch, Gerda Leisinger, E J R van Beek, Allan W Reid, Jeffrey J Brown, Thomas C Yu, Scott D Flamm, Christoph Düber, Werner Judmaier, Peter Reimer, Michael Stiskal, Bernhard Kramann, Steve Wolff, and Christiane Blankenstein.
• Hospital Dresden-Friedrichstadt, Germany. kittner-th@khdf.de
• Eur J Radiol. 2007 Dec 1; 64 (3): 456-64.

PurposeTo determine the most efficacious dose of gadodiamide for three-dimensional (3D) contrast-enhanced (CE) magnetic resonance angiography (MRA) of the renal arteries on a patient level based on the sensitivity in detecting the main hemodynamically relevant (> or =50% or occlusion) renal artery stenosis (RAS) using intra-arterial digital subtraction angiography (IA DSA) as the gold standard.Materials And MethodsThis prospective, randomized, double-blind, parallel-group, multicenter study included 273 patients referred to IA DSA for suspected RAS. Patients underwent 3D CE MRA after injection of 0.01, 0.05, 0.1, or 0.2mmol/kg of body weight gadodiamide (0.5mmol/ml). The images were assessed for location and degree of RAS by independent blinded readers (MRA: three readers, IA DSA: one reader). Hypothesis testing for a significant trend in sensitivity across dose groups was based on the one-sided Cochran-Armitage style trend test for each independent MRA reader.ResultsThe lowest dose group (0.01mmol/kg) proved non-efficacious in detecting hemodynamically relevant (i.e., > or =50% or occlusion) RAS. A statistically significant dose trend (p<0.001) was shown for each of the three independent readers. Depending on reader, the sensitivity obtained with 0.05, 0.1, and 0.2mmol/kg was 63.9-86.1%, 75.8-91.4% and 80.6-90.6%, the specificity was 66.7-73.9%, 59.3-75.0%, and 59.3-75.0% and accuracy was 67.8-78.9%, 75.4-77.4%, and 76.3-81.0%, for the three dose groups, respectively. There were eight non-severe adverse events (AEs). Three serious AEs occurring in one patient were judged not related to gadodiamide by the on-site investigator.ConclusionA significant dose trend between the four doses examined was observed. The lowest dose (0.01mmol/kg) differed significantly from those of the other three doses. Based on the analysis of the primary and secondary endpoints, 0.1mmol/kg gadodiamide appears to be the most suitable dose in diagnosing hemodynamically relevant RAS. The present study also demonstrated gadodiamide to be safe and well tolerated.

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