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(Radiology. 2000;215:727-736.)
© RSNA, 2000

Gastrointestinal Imaging

Focal Liver Lesions: Evaluation of the Efficacy of Gadobenate Dimeglumine in MR Imaging-A Multicenter Phase III Clinical Study1

Jan Petersein, MD, Alberto Spinazzi, MD, Andrea Giovagnoni, MD, Philippe Soyer, MD, Francois Terrier, MD, Riccardo Lencioni, MD, Carlo Bartolozzi, MD, Luigi Grazioli, MD, Antonio Chiesa, MD, Riccardo Manfredi, MD, Pasquale Marano, MD, Els L. Van Persijn van Meerten, MD, Johannes L. Bloem, MD, Carina Petre, MD, Guy Marchal, MD, Alina Greco, MD, Michael T. McNamara, MD, Andreas Heuck, MD, Maximilian Reiser, MD, Michael Laniado, MD, Claus Claussen, MD, Heike E. Daldrup, MD, Ernst Rummeny, MD, Miles A. Kirchin, PhD, Gianpaolo Pirovano, MD and Bernd Hamm, MD

1 From the Institute for Radiodiagnostics, Medizinische Fakultät der Humboldt-Universität, Berlin, Germany (J.P., B.H.). Medical and Regulatory Affairs, Bracco SpA, Milan, Italy (G.P., M.A.K., A.S.); Centro di Risonanza Magnetica, Ospedale Torrette, Ancona, Italy (A. Giovagnoni); Departement de Radiologie, Hopital Lariboisière, Paris, France (P.S.); Departement de Radiologie, Hopital Cantonal Universitaire, Geneva, Switzerland (F.T.); Instituto di Radiologia, Ente Ospedaliero di Pisa, Italy (R.L., C.B.); II Servizio di Radiologia, Ente Ospedaliero Spedali Civili, Brescia, Italy (L.G., A.C.); Instituto di Radiologia, Policlinico A. Gemelli, Rome, Italy (R.M., P.M.); Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands (E.L.V.P.v.M., J.L.B.); Department of Radiology, University Hospital Leuven, Belgium (C.P., G.M.); MRI Centre, Princess Grace Hospital, Monaco, Principaute de Monaco (A. Greco, M.T.M.); Ludwig-Maximilians-Universität-München, Institute für Radiologische Klinik, München, Germany (A.H., M.R.); Eberhardt Karls-Universität, Radiologische Universitätsklinik, Abteilung für Radiologische Diagnostik, Tübingen, Germany (M.L., C.C.); and Westfälische Wilhelms-Universität Münster, Institute für Klinische Radiologie, Münster, Germany (H.E.D., E.R.). Received Oct 12, 1998; revision requested Dec 11; final revision received Oct 8, 1999; accepted Oct 17. Address correspondence to A.S., Bracco SpA, Medical and Regulatory Affairs, Via Egidio Folli 50, 20134 Milan, Italy (e-mail: aspinazzi@bracco.it).

PURPOSE: To evaluate gadobenate dimeglumine (Gd-BOPTA) for dynamic and delayed magnetic resonance (MR) imaging of focal liver lesions.

MATERIALS AND METHODS: In 126 of 214 patients, MR imaging was performed before Gd-BOPTA administration, immediately after bolus administration of a 0.05- mmol/kg dose of Gd-BOPTA, and 60–120 minutes after an additional intravenously infused 0.05-mmol/kg dose. In 88 patients, imaging was performed before and 60–120 minutes after a single, intravenously infused 0.1-mmol/kg dose. T1- and T2-weighted spin-echo and T1-weighted gradient-echo images were acquired. On-site and blinded off-site reviewers prospectively evaluated all images. Intraoperative ultrasonography, computed tomography (CT) during arterial portography, and/or CT with iodized oil served as the reference methods in 110 patients.

RESULTS: Significantly more lesions were detected on combined pre- and postcontrast images compared with on precontrast images alone (P < .01). All reviewers reported a decreased mean size of the smallest detected lesion and improved lesion conspicuity on postcontrast images. All on-site reviewers and two off-site reviewers reported increased overall diagnostic confidence (P < .01). Additional lesion characterization information was provided on up to 109 (59%) of 184 delayed images and for up to 50 (42%) of 118 patients in whom dynamic images were assessed. Gd-BOPTA would have helped change the diagnosis in 99 (47%) of 209 cases and affected patient treatment in 408 (23%) of 209 cases.

CONCLUSION: Gd-BOPTA increases liver lesion conspicuity and detectability and aids in the characterization of lesions.

Index terms: Contrast media • Gadobenate dimeglumine • Liver neoplasms, 76.316, 76.32, 76.33 • Liver neoplasms, MR, 76.121411, 76.121412, 76.121416, 76.12143 • Magnetic resonance (MR), contrast media, 76.12143 • Magnetic resonance (MR), phase imaging, 76.121411, 76.121412, 76.121416, 76.12143




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