1. 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
- Author
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Wolfgang Brodtrager, Walter Gross-fengels, Bernd Tombach, Claus D. Claussen, Paul Hajek, Giacomo Gortenuti, Christoph Düber, Eckhardt Grabbe, Ernst J. Rummeny, Małgorzata Szczerbo-Trojanowska, Peter Reimer, Raymond Oyen, Michael Kuhn, Philipp Lengsfeld, Michael Galanski, Roberto Lagalla, Christiane Pering, Andrzej Urbanik, Roberto Pozzi-Mucelli, Reinhard Loose, Thorsten Persigehl, Pietro Pavlica, Gertraud Heinz-Peer, Götz M. Richter, Gregor Jung, Renate Hammerstingl, F. K. W. Schäfer, Brigitte Happel, Nomdo S. Renken, Thomas Kittner, Thomas J. Vogl, Klaus Bohndorf, TOMBACH B, BOHNDORF K, BRODTRAGER W, CLAUSSEN CD, DÜBER C, GALANSKI M, GRABBE, GORTENUTI G, KUHN M, GROSS-FENGELS W, HAMMERSTINGL R, HAPPEL B, HEINZ-PEER G, JUNG G, KITTNER T, LAGALLA R, LENGSFELD P, LOOSE R, OYEN RH, PAVLICA P, PERING C, POZZI-MUCELLI R, PERSIGEHL T, REIMER P, RENKEN NS, RICHTER GM, RUMMENY EJ, SCHÄFER F, SZCZERBO-TROJANOWSKA M, URBANIK A, VOGL TJ, HAJEK P, and Radiology & Nuclear Medicine
- Subjects
Gadobutrol ,Gadopentate dimeglumine ,Renal lesions ,MRI ,Diagnostic differentiation ,Noninferiority ,Gadolinium DTPA ,Male ,medicine.medical_specialty ,Contrast Media ,Sensitivity and Specificity ,law.invention ,Precontrast ,Randomized controlled trial ,magnetic resonance, contrast media ,law ,medicine ,Organometallic Compounds ,Humans ,Radiology, Nuclear Medicine and imaging ,Single-Blind Method ,ddc:610 ,Neuroradiology ,medicine.diagnostic_test ,business.industry ,Ultrasound ,Reproducibility of Results ,Magnetic resonance imaging ,Interventional radiology ,General Medicine ,Middle Aged ,Image Enhancement ,Magnetic Resonance Imaging ,Kidney Neoplasms ,Clinical trial ,Europe ,Radiology Nuclear Medicine and imaging ,Female ,Radiology ,business ,Nuclear medicine ,medicine.drug - 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.
- Published
- 2008