Comparison of 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine-enhanced MRI in 471 patients with known or suspected renal lesions: results of a multicenter, single-blind, interindividual, randomized clinical phase III trial

Abstract

The purpose of this phase III clinical trial was to compare two different extracellular contrast agents, 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine, for magnetic resonance imaging (MRI) in patients with known or suspected focal renal lesions. Using a multicenter, single-blind, interindividual, randomized study design, both contrast agents were compared in a total of 471 patients regarding their diagnostic accuracy, sensitivity, and specificity to correctly classify focal lesions of the kidney. To test for noninferiority the diagnostic accuracy rates for both contrast agents were compared with CT results based on a blinded reading. The average diagnostic accuracy across the three blinded readers ('average reader') was 83.7% for gadobutrol and 87.3% for gadopentate dimeglumine. The increase in accuracy from precontrast to combined precontrast and postcontrast MRI was 8.0% for gadobutrol and 6.9% for gadopentate dimeglumine. Sensitivity of the average reader was 85.2% for gadobutrol and 88.7% for gadopentate dimeglumine. Specificity of the average reader was 82.1% for gadobutrol and 86.1% for gadopentate dimeglumine. In conclusion, this study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol compared with 0.5 M gadopentate dimeglumine in the diagnostic assessment of renal lesions with CE-MRI.

Effects of gadolinium-based contrast agent concentrations (0.5 M or 1.0 M) on the diagnostic performance of magnetic resonance imaging examinations: systematic review of the literature

“…Three of these studies, using MRA (4,6,10), showed no difference in qualitative parameters such as image quality or diagnostic confidence and only one found a higher SNR and CNR in favor of gadobutrol. The other two studies found no statistical advantage for the 1.0 M GBCA in terms of sensitivity, specificity and accuracy for lesion detection and characterization in patients with renal (14) or liver (15) cancer.…”

Intra-individual, randomised comparison of the MRI contrast agents gadobutrol and gadoterate in imaging the distal lower limb of patients with known or suspected osteomyelitis, evaluated in an off-site blinded read

“…In abdominal dynamic MR angiography gadobutrol has superior contrast compared with 0.5 M GBCA [20]. Some publications report the use of gadobutrol for indications other than in CNS imaging and MR angiography [21,22]. Until now, no one has evaluated this Gd chelate in a direct comparison to another contrast agent for musculo-skeletal imaging purposes.…”

High-relaxivity contrast-enhanced magnetic resonance neuroimaging: a review

“…Quantitatively, the SNR and CNR for gadobenate dimeglumine and both standard and diluted forms of gadobutrol were significantly (p<0.02) higher than gadopentetate dimeglumine, yet no significant difference between either form of gadobutrol and gadobenate dimeglumine was reported. Overall, it seems that 1 M gadobutrol may or may not be advantageous for MRA compared with conventional Gd contrast agents, depending on the vascular territory being investigated [41,[59][60][61][62]65], but it has not demonstrated benefit beyond the higher relaxivity agents for CE-MRA [63,64].…”