Bernd Tombach, Klaus Bohndorf, Wolfgang Brodtrager, Claus D. Claussen, Christoph Düber, Michael Galanski, Eckhardt Grabbe, Giacomo Gortenuti, Michael Kuhn, Walter Gross-Fengels, Renate Maria 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
- 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.
MetadatenAuthor: | Bernd Tombach, Klaus Bohndorf, Wolfgang Brodtrager, Claus D. Claussen, Christoph Düber, Michael Galanski, Eckhardt Grabbe, Giacomo Gortenuti, Michael Kuhn, Walter Gross-Fengels, Renate Maria HammerstinglGND, 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. VoglORCiDGND, Paul Hajek |
---|
URN: | urn:nbn:de:hebis:30:3-380199 |
---|
DOI: | https://doi.org/10.1007/s00330-008-1054-2 |
---|
ISSN: | 1432-1084 |
---|
Pubmed Id: | https://pubmed.ncbi.nlm.nih.gov/18607594 |
---|
Parent Title (English): | European radiology |
---|
Publisher: | Springer |
---|
Place of publication: | Berlin ; Heidelberg |
---|
Document Type: | Article |
---|
Language: | English |
---|
Date of Publication (online): | 2008/07/08 |
---|
Date of first Publication: | 2008/07/08 |
---|
Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
---|
Release Date: | 2015/10/13 |
---|
Tag: | Diagnostic differentiation; Gadobutrol; Gadopentate dimeglumine; MRI; Noninferiority; Renal lesions |
---|
Volume: | 18 |
---|
Issue: | 11 |
---|
Page Number: | 10 |
---|
First Page: | 2610 |
---|
Last Page: | 2619 |
---|
Note: | 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. |
---|
HeBIS-PPN: | 371513146 |
---|
Institutes: | Medizin / Medizin |
---|
Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
---|
Sammlungen: | Universitätspublikationen |
---|
Licence (German): | Creative Commons - Namensnennung-Nicht kommerziell 3.0 |
---|