Efficacy and safety of gadodiamide (Gd-DTPA-BMA) in renal 3D-magnetic resonance angiography (MRA): a phase II study.

Abstract

PURPOSE:

To 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 METHODS:

This 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.

RESULTS:

The 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.

CONCLUSION:

A 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.

• Authors: 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, Christiane Blankenstein
• Journal: European journal of radiology (Eur J Radiol) Vol. 64 Issue 3 Pg. 456-64 (Dec 2007) ISSN: 0720-048X [Print] Ireland
• PMID: 17412546 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Contrast Media
• gadodiamide
• Gadolinium DTPA

Topics

• Adult
• Aged
• Aged, 80 and over
• Angiography, Digital Subtraction
• Contrast Media (administration & dosage, adverse effects)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Gadolinium DTPA (administration & dosage, adverse effects)
• Humans
• Image Enhancement (methods)
• Image Processing, Computer-Assisted (methods)
• Imaging, Three-Dimensional (methods)
• Injections, Intravenous
• Magnetic Resonance Angiography (methods)
• Male
• Middle Aged
• Prospective Studies
• Renal Artery Obstruction (diagnosis)
• Safety
• Sensitivity and Specificity
• Treatment Outcome