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Open Access 01-11-2008 | Magnetic Resonance

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

Authors: Bernd Tombach, Klaus Bohndorf, Wolfgang Brodtrager, Claus D. Claussen, Christoph Düber, Michael Galanski, Eckhardt Grabbe, Giacomo Gortenuti, Michael Kuhn, Walter Gross-Fengels, Renate Hammerstingl, Brigitte Happel, Gertraud Heinz-Peer, Gregor Jung, Thomas Kittner, Roberto Lagalla, Philipp Lengsfeld, Reinhard Loose, Raymond H. G. Oyen, Pietro Pavlica, Christiane Pering, Roberto Pozzi-Mucelli, Thorsten Persigehl, Peter Reimer, Nomdo S. Renken, Götz M. Richter, Ernst J. Rummeny, Fritz Schäfer, Malgorzata Szczerbo-Trojanowska, Andrzej Urbanik, Thomas J. Vogl, Paul Hajek

Published in: European Radiology | Issue 11/2008

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.

For example, Omniscan® (Gadodiamide) GE Healthcare, ProHance® (Gadoteridol) Bracco, Dotarem® (Gd-DOTA) Guerbet

Diagnostic sensitivity determines the rate of correctly identified malignant lesions in comparison with the respective standard of truth (SOT), and is defined as the number of correctly localized and classified malignant lesions (TP) divided by the total number of malignant SOT lesions.

The specificity rate for lesion classification is defined as the number of correctly localized and classified benign lesions (TN) divided by the total number of patients with benign SOT lesions.

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Title: 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
Authors: Bernd Tombach
Klaus Bohndorf
Wolfgang Brodtrager
Claus D. Claussen
Christoph Düber
Michael Galanski
Eckhardt Grabbe
Giacomo Gortenuti
Michael Kuhn
Walter Gross-Fengels
Renate Hammerstingl
Brigitte Happel
Gertraud Heinz-Peer
Gregor Jung
Thomas Kittner
Roberto Lagalla
Philipp Lengsfeld
Reinhard Loose
Raymond H. G. Oyen
Pietro Pavlica
Christiane Pering
Roberto Pozzi-Mucelli
Thorsten Persigehl
Peter Reimer
Nomdo S. Renken
Götz M. Richter
Ernst J. Rummeny
Fritz Schäfer
Malgorzata Szczerbo-Trojanowska
Andrzej Urbanik
Thomas J. Vogl
Paul Hajek
Publication date: 01-11-2008
Publisher: Springer-Verlag
Published in: European Radiology / Issue 11/2008
Print ISSN: 0938-7994
Electronic ISSN: 1432-1084
DOI: https://doi.org/10.1007/s00330-008-1054-2

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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

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Abstract

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