Comparison of 1.0 M gadobutrol and 0.5 M gadopentetate dimeglumine-enhanced magnetic resonance imaging in five hundred seventy-two patients with known or suspected liver lesions: results of a multicenter, double-blind, interindividual, randomized clinical phase-III trial.

Abstract

OBJECTIVE:

To 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 MATERIALS:

A 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.

RESULTS:

A 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.

CONCLUSION:

This 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.

• Authors: 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, Bernd Tombach
• Journal: Investigative radiology (Invest Radiol) Vol. 44 Issue 3 Pg. 168-76 (Mar 2009) ISSN: 1536-0210 [Electronic] United States
• PMID: 19169143 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Contrast Media
• Organometallic Compounds
• gadobutrol
• Gadolinium DTPA

Topics

• Contrast Media
• Double-Blind Method
• Europe (epidemiology)
• Female
• Gadolinium DTPA (administration & dosage)
• Humans
• Image Enhancement (methods)
• Liver Neoplasms (epidemiology, pathology)
• Magnetic Resonance Imaging (statistics & numerical data)
• Male
• Middle Aged
• Organometallic Compounds (administration & dosage)
• Prevalence
• Reproducibility of Results
• Sensitivity and Specificity