• Renate Hammerstingl, Gerhard Adam, Juan-Ramon Ayuso, Bernard Van Beers, Giuseppe Belfiore, Marie-France Bellin, Georg Bongartz, Olivier Ernst, Bernd Frericks, Gianmarco Giuseppetti, Gertrud Heinz-Peer, Andrea Laghi, Julio Martin, Christiane Pering, Peter Reimer, Götz-Martin Richter, Frank W Roemer, Fritz K W Schäfer, Valérie Vilgrain, Thomas J Vogl, Dominik Weishaupt, Alexander Wall, Christoph J Zech, and Bernd Tombach.
• Department of Diagnostic and Interventional Radiology, Johann Wolfgang Goethe University Hospital, Frankfurt am Main, Germany. Hammerstingl@em.uni-frankfurt.de
• Invest Radiol. 2009 Mar 1; 44 (3): 168-76.

ObjectiveTo evaluate the diagnostic efficacy (accuracy, sensitivity, specificity) of 1.0 M gadobutrol versus 0.5 M gadopentetate for the classification of lesions as either benign or malignant in patients with known or suspected liver lesions.Methods And MaterialsA multicenter, phase-III, randomized, interindividually controlled comparison study with blinded reader evaluation was performed to investigate the diagnostic efficacy of a bolus injection of 1.0 M gadobutrol compared with 0.5 M gadopentetate at a dose of 0.1 mmol Gd/kg BW. The imaging protocol included a dynamic 3D-evaluation, static conventional, and fat saturated T1-weighted sequences. MR datasets were evaluated by 3 independent radiologists. The standard of reference was defined by an independent truth panel (radiologist or hepatologist). The safety evaluation included adverse events, vital signs, and physical examination.ResultsA total of 497 of 572 patients were eligible for the final efficacy analysis. Noninferiority of gadobutrol-enhanced magnetic resonance imaging (MRI) for the classification of liver lesions was demonstrated on the basis of diagnostic accuracy determined by the on-site investigators (-0.098, 0.021) as well as for the average reader of the blinded evaluation (-0.096, 0.014) (95% confidence interval), compared with the predefined standard of reference. Very similar increases in sensitivity (ranging from approximately 10% to approximately 55%) and specificity (ranging from approximately 1% to approximately 18%) compared with precontrast MRI were also observed for the 2 contrast agent groups, with maximum differences of 4%.Very similar, low rates of adverse events were recorded for each of the 2 groups. No clinically relevant changes in vital signs or the results of the physical examination were observed in any patient.ConclusionThis study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol (0.1 mmol/kg body weight) to 0.5 M gadopentetate (0.1 mmol/kg body weight) in the diagnostic assessment of liver lesions with contrast-enhanced MRI. The known excellent safety profile of gadobutrol was confirmed in this clinical trial and is similar to that of gadopentetate.

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