TY  - JOUR
A1  - Tombach, Bernd
A1  - Bohndorf, Klaus
A1  - Brodtrager, Wolfgang
A1  - Claussen, Claus D.
A1  - Düber, Christoph
A1  - Galanski, Michael
A1  - Grabbe, Eckhardt
A1  - Gortenuti, Giacomo
A1  - Kuhn, Michael
A1  - Gross-Fengels, Walter
A1  - Hammerstingl, Renate Maria
A1  - Happel, Brigitte
A1  - Heinz-Peer, Gertraud
A1  - Jung, Gregor
A1  - Kittner, Thomas
A1  - Lagalla, Roberto
A1  - Lengsfeld, Philipp
A1  - Loose, Reinhard
A1  - Oyen, Raymond H. G.
A1  - Pavlica, Pietro
A1  - Pering, Christiane
A1  - Pozzi-Mucelli, Roberto
A1  - Persigehl, Thorsten
A1  - Reimer, Peter
A1  - Renken, Nomdo S.
A1  - Richter, Götz M.
A1  - Rummeny, Ernst J.
A1  - Schäfer, Fritz
A1  - Szczerbo-Trojanowska, Malgorzata
A1  - Urbanik, Andrzej
A1  - Vogl, Thomas J.
A1  - Hajek, Paul
T1  - 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
T2  - European radiology
N2  - 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.
KW  - Gadobutrol
KW  - Gadopentate dimeglumine
KW  - Renal lesions
KW  - MRI
KW  - Diagnostic differentiation
KW  - Noninferiority
Y1  - 2008
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/38019
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-380199
SN  - 1432-1084
N1  - This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.
VL  - 18
IS  - 11
SP  - 2610
EP  - 2619
PB  - Springer
CY  - Berlin ; Heidelberg
ER  -