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Gadobenate Dimeglumine-Enhanced MRI of the Breast: Analysis of Dose Response and Comparison with Gadopentetate Dimeglumine

¹ Department of Radiology, German Cancer Research Center, Im Neuenheimer Feld 280, D-69120 Heidelberg, Germany.
³ Department of Diagnostic Radiology, University Hospital of Wales, Health Park, Cardiff CF4 4XN, United Kingdom.
⁴ Biomedical SpA., Servizio di Radiologia, Via Prà 1/b, 16157 Genova, Italy.
⁵ Department of Radiology, Leiden University Medical Center, Albinusdreef 2, 2333 AA Leiden, The Netherlands.
⁶ Istituto di Scienze Radiologiche e Formazione dell'Immagine, Ospedale SS. Annunziata, Via P. Valignani 66100, Chieti, Italy.
⁷ Department of Radiology, University Hospital Nijmegen-St. Radboud, 6500 HB Nijmegen, The Netherlands.
⁸ Eberhardt Karls-Universität, Radiologische Universitätsklinik, Abteilung für Radiologische Diagnostik, Hoppe-Seyler-Str. 3, 72076 Tübingen, Germany.
⁹ MRI Department, Middlesex Hospital, Mortimer St., London W1 N8AA, United Kingdom.
¹⁰ Medizinische Fakultät der Humboldt-Universität, Institut für Röntgendiagnostik Charité, Schumannstr. 20/21, D-10098 Berlin, Germany.
¹¹ Radiologia e Diagnostica per Immagini, Ospedale Generale S. Giovanni Calibita, Fatebene Fratelli, Isola Tiberina 39, 00186 Rome, Italy.
¹² Instituto di Radiologia, Ente Ospedaliero di Pisa, Via Roma 67, 56125 Pisa, Italy.
¹³ Institut für Radiologische Diagnostik, Ludwig-Maximilians-Universität, Klinikum Grosshadern, 81377 Munich, Germany.
¹⁴ Röntgendiagnostik I, Georg-August-Universität, Robert Koch Str. 40, D-37075 Göttingen, Germany.
¹⁵ Department of Diagnostic Radiology, University Hospital, 66421 Homburg/Saar, Germany.
¹⁶ State University Hospital, Hanzeplein 1, P. O. Box 30.001, 9700 RB Groningen, The Netherlands.
¹⁷ Department of Radiology, Northwick Park Hospital, Watford Rd., Harrow HA1 3UG, United Kingdom.
¹⁸ Institut für Radiologie Medizinischen, Universität Lübeck, Ratzeburger Allee 160, D-23538 Lübeck, Germany.
¹⁹ Worldwide Medical Affairs, Bracco Imaging SpA., Via E. Folli 50, 20134 Milano, Italy.

OBJECTIVE. The purpose of this study was to evaluate the clinical efficacy and dose response relationship of three doses of gadobenate dimeglumine for MRI of the breast and to compare the results with those obtained after a dose of 0.1 mmol/kg of body weight of gadopentetate dimeglumine.

SUBJECTS AND METHODS. Gadobenate dimeglumine at 0.05, 0.1, or 0.2 mmol/kg of body weight or gadopentetate dimeglumine at 0.1 mmol/kg of body weight was administered by IV bolus injection to 189 patients with known or suspected breast cancer. Coronal three-dimensional T1-weighted gradient-echo images were acquired before and at 0, 2, 4, 6, and 8 min after the administration of the dose. Images were evaluated for lesion presence, location, size, morphology, enhancement pattern, conspicuity, and type. Lesion signal intensity-time curves were acquired, and lesion matching with on-site final diagnosis was performed. A determination of global lesion detection from unenhanced to contrast-enhanced and combined images was performed, and evaluations were made of the diagnostic accuracy for lesion detection and characterization. A full safety evaluation was conducted.

RESULTS. Significant dose-related increases in global lesion detection were noted for patients who recieved gadobenate dimeglumine (p < 0.04, all evaluations). The sensitivity for detection was comparable for 0.1 and 0.2 mmol/kg of gadobenate dimeglumine, and specificity was highest with the 0.1 mmol/kg dose. Higher detection scores and higher sensitivity values for lesion characterization were found for 0.1 mmol/kg of gadobenate dimeglumine compared with 0.1 mmol/kg of gadopentetate dimeglumine, although more variable specificity values were obtained. No differences in safety were observed, and no serious adverse events were reported.

CONCLUSION. Gadobenate dimeglumine is a capable diagnostic agent for MRI of the breast. Although preliminary, our results suggest that 0.1 mmol/kg of gadobenate dimeglumine may offer advantages over doses of 0.05 and 0.2 mmol/kg of gadobenate dimeglumine and 0.1 mmol/kg of gadopentetate dimeglumine for breast lesion detection and characterization.

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