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

摘要: The purpose of this phase III clinical trial was to compare two different extracellular contrast agents, 1.0 M gadobutrol and 0.5 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 agents were compared total 471 regarding their diagnostic accuracy, sensitivity, specificity correctly classify lesions the kidney. To test noninferiority accuracy rates CT results based on blinded reading. average across three readers (‘average reader’) 83.7% 87.3% dimeglumine. increase from precontrast combined postcontrast MRI 8.0% 6.9% Sensitivity reader 85.2% 88.7% Specificity 82.1% 86.1% In conclusion, documents evidence single i.v. bolus injection dimeglumine assessment CE-MRI.