Comparison of 0.5 M gadoterate and 1.0 M gadobutrol in peripheral MRA: a prospective, single-center, randomized, crossover, double-blind study

J Magn Reson Imaging. 2012 Nov;36(5):1213-21. doi: 10.1002/jmri.23760. Epub 2012 Jul 30.

Abstract

Purpose: To evaluate the diagnostic efficacy of macrocyclic paramagnetic gadolinium (Gd) chelates gadoterate (0.5 mmol/mL) and gadobutrol (1.0 mmol/mL) for the diagnosis of clinically significant abdominal/lower limb arterial diseases at 3.0T.

Materials and methods: This study was conducted as a prospective, single-center, randomized, double-blind, intraindividual study comparing single dose (0.1 mmol/kg) gadoterate enhanced-MRA (magnetic resonance angiography) with gadobutrol enhanced-MRA at 3.0T for their diagnostic potential in patients with peripheral artery disease. A total of 20 patients were included in this trial.

Results: Fourteen patients were eligible for the final efficacy analysis. The overall image quality (excellent/more than adequate) was better rated with gadoterate than with gadobutrol (100% vs. 78.6%, 100% vs. 92.9%, 100% vs. 85.7%, 100% vs. 85.7% for readers 1, 2, 3, 4, respectively). Diagnostic confidence was rated high/excellent in 100% (readers 1, 2, and 3) and 92.9% (reader 4) with gadoterate compared to 92.9% (readers 1 and 2) and 85.7% (readers 3 and 4) with gadobutrol. Higher signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) values were obtained for gadobutrol compared to gadoterate (26.1/23.4, P = 0.01, and 22.7/20.2, P = 0.01). For the secondary criteria, no differences between groups were reported. No adverse events were reported.

Conclusion: Gadobutrol yielded significantly higher SNR/CNR while gadoterate was better rated in terms of overall image quality and diagnostic confidence (P > 0.05).

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Contrast Media / administration & dosage
  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Heterocyclic Compounds / administration & dosage*
  • Humans
  • Magnetic Resonance Angiography / methods*
  • Male
  • Middle Aged
  • Organometallic Compounds / administration & dosage*
  • Peripheral Arterial Disease / pathology*
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • Contrast Media
  • Heterocyclic Compounds
  • Organometallic Compounds
  • gadobutrol
  • gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate