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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.

Author(s): Hammerstingl R, Adam G, Ayuso JR, Van Beers B, Belfiore G, Bellin MF, Bongartz G, Ernst O, Frericks B, Giuseppetti G, Heinz-Peer G, Laghi A, Martin J, Pering C, Reimer P, Richter GM, Roemer FW, Schafer FK, Vilgrain V, Vogl TJ, Weishaupt D, Wall A, Zech C, Tombach B

Affiliation(s): From the *Department of Diagnostic and Interventional Radiology, Johann Wolfgang Goethe University Hospital, Frankfurt, Germany; daggerUniversitatsklinikum Hamburg Eppendorf, Radiologische Klinik und Poliklinik, Hamburg, Germany; double daggerHospital Clinico y Provincial Servicio de Radiodiagnostico, Barcelona, Spain; section signDepartment of Radiology, St-Luc University Hospital, Universite Catholique de Louvain, Brussels, Belgium; paragraph signDipartimento di Diagnostica per Immagini, Azienda Ospedalliera di Rilievo Nazionale di Alta, Speciallizzazione (A.O.R.N.), Caserta, Italy; parallelService de Radiologie, Paul Brousse Hospital, Villejuif Cedex, France; **Department Medizinische Radiologie, Universitatsspital Basel, Basel, Switzerland; double daggerdouble daggerHospital Huriez Service de Radiologie, Lille, France; section sign section signCentro di Risonanza Magnetica, Ospedale Regionale "Torrette," Instituto di Radiologia, Ancona, Italy; paragraph sign paragraph signKlinik fur Diagnostische Radiologie, Universitatsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany; parallel parallelAllgemeines Krankenhaus der Stadt Wien, Universitatsklinik fur Radiodiagnostik, Wien, Austria; ***Centre Diagnostic, UDIAT Parc Tauli, Corporacion Sanitaria, Barcelona, Spain; daggerdaggerdaggerIstituto di Radiologia Centrale, Policlinico Umberto I, Rome, Italy; double daggerdouble daggerdouble daggerBayer Schering Pharma, BU Diagnostic Imaging, Berlin, Germany; section sign section sign section signStadtisches Klinikum Karlsruhe, Zentralinstitut fur Bildgebende Diagnostik, Karlsruhe, Germany; paragraph sign paragraph sign paragraph signKlinikum Grosshadern, Radiologische Klinik und Poliklinik, Munchen, Germany; parallel parallel parallelZentrum Chirurgie, Radiologie, Klinikum der Universitat Heidelberg,Heidelberg, Germany; ****Klinik fur Diagnostische Radiologie und Neuroradiologie, Klinikum Augsburg, Augsburg, Germany; daggerdaggerdaggerdaggerHopital Beaujon, Clichy, France, Germany; double daggerdouble daggerdouble daggerdouble daggerDepartment of Medizinische Radiologie, Universitatsspital Zurich, MRI-Zentrum, Zurich, Switzerland; section sign section sign section sign section signInstitut fur Klinische Radiologie, Westfalische Wilhelms-Universitat Munster, Munster; paragraph sign paragraph sign paragraph sign paragraph signUniversitatsklinikum Benjamin Franklin, Rontgendiagnostik, Berlin, Germany; and parallel parallel parallel parallelRontgen- und Strahlenklinik, Klinikum Osnabruck, Osnabruck, Germany.

Publication date & source: 2009-01-22, Invest Radiol., [Epub ahead of print]

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%- 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.

Page last updated: 2009-02-08

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