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

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. YuScott D. Flamm, Christoph Düber, Werner Judmaier, Peter Reimer, Michael Stiskal, Bernhard Kramann, Steve Wolff, Christiane Blankenstein

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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 (≥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 0.2 mmol/kg of body weight gadodiamide (0.5 mmol/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 (0.01 mmol/kg) proved non-efficacious in detecting hemodynamically relevant (i.e., ≥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 0.2 mmol/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 (0.01 mmol/kg) differed significantly from those of the other three doses. Based on the analysis of the primary and secondary endpoints, 0.1 mmol/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.

Original languageEnglish
Pages (from-to)456-464
Number of pages9
JournalEuropean journal of radiology
Volume64
Issue number3
DOIs
Publication statusPublished - Dec 1 2007

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Keywords

  • Angiography
  • Clinical trials
  • Digital subtraction angiography
  • Gd-DTPA-BMA
  • Intra-arterial
  • Magnetic resonance imaging
  • Phase II
  • Renal artery stenosis

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

Kittner, T., Rudolf, J., Fages, J. F., Legmann, P., Aschauer, M., Repa, I., Alvares, M. R., Savalegui, I., Ittrich, H., Geterud, K., de Kevviler, E., Ayuso, J., Lockhart, M. E., Blum, A., Iliasch, H., Leisinger, G., van Beek, E. J. R., Reid, A. W., Brown, J. J., ... Blankenstein, C. (2007). Efficacy and safety of gadodiamide (Gd-DTPA-BMA) in renal 3D-magnetic resonance angiography (MRA): A phase II study. European journal of radiology, 64(3), 456-464. https://doi.org/10.1016/j.ejrad.2007.02.034