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Gadobenate Dimeglumine—Enhanced MR Angiography of the Abdominal Aorta and Renal Arteries

¹ Department of Radiology, Universitätsklinikum Charité, Medizinische Fakultät, Humboldt-Universität zu Berlin, Schumannstr. 20/21, 10098 Berlin, Germany.
² Department of Radiology, Leiden University Medical Center, Albinusdreef 2, 2333 AA Leiden, The Netherlands.
³ Department of Radiology, Erasmus University Medical Center Rotterdam, 40, Doctor Molewaterplein, NL 3015 GD Rotterdam, The Netherlands.
⁴ Department of Radiology, University Hospital Nijmegen—St. Radboud, 6500 HB Nijmegen, The Netherlands.
⁵ Abt. Röntgendiagnostik I, Klinikum der Georg-August-Universität, Robert-Koch-Str. 40, D-37075 Göttingen, Germany.
⁶ Department of Radiology, University Hospital Leuven, Herestr. 49, 3000 Leuven, Belgium.
⁷ Department of Radiology, German Cancer Research Center, Im Neuenheimer Feld 280, D-69120 Heidelberg, Germany.
⁸ Department of Diagnostic Radiology, University Hospital, 66421 Homburg/Saar, Germany.
⁹ Instituto di Scienze Radiologiche e Formazione dell'Immagine, Ospedale SS. Annunziata, Via P Valignani 66100, Chieti, Italy.
¹⁰ Magnetic Resonance Unit, Royal Brompton Hospital, Sidney St., London SW3 6NP, United Kingdom.
¹¹ Department of Radiology, Scientific Institute S. Raffaele, University Hospital, Milan, Italy.
¹² Bracco-Byk Gulden, Max Stromeyer Str., 57, 78467 Konstanz, Germany.
¹³ Worldwide Medical Affairs, Bracco Imaging SpA, Via E. Folli, 50, 20134, Milano, Italy.

OBJECTIVE. This study was conducted to determine the efficacy and safety of four different doses of gadobenate dimeglumine for contrast-enhanced three-dimensional MR angiography of the abdominal aorta and renal arteries.

SUBJECTS AND METHODS. Ninety-four patients with suspected abnormality of the abdominal aorta or renal arteries underwent unenhanced three-dimensional gradient-recalled echo time-of-flight MR angiography and contrast-enhanced MR angiography after the IV injection of one of four doses of gadobenate dimeglumine (0.025, 0.05, 0.1, and 0.2 mmol/kg of body weight). Efficacy was assessed on-site and by two blinded off-site reviewers in terms of change in total diagnostic quality score and diagnostic quality score per vessel segment from baseline unenhanced time-of-flight MR angiography to contrast-enhanced MR angiography. Secondary efficacy end points included lesion count and level of confidence in lesion characterization. Safety assessments comprised adverse event monitoring, physical evaluation, vital signs, ECG, and laboratory investigations.

RESULTS. A significant change in the total diagnostic quality score from unenhanced to contrast-enhanced MR angiography was observed at all doses. The change increased with increased dose, plateauing at the 0.1 mmol/kg dose level. More patients with lesions detected and increased reviewer confidence for lesion characterization were noted on contrast-enhanced MR angiography compared with unenhanced MR angiography, although no dose-related trends were observed. All doses were well tolerated, and no significant changes in safety parameters were observed.

CONCLUSION. Gadobenate dimeglumine is an effective and safe agent for contrast-enhanced MR angiography of the abdominal aorta and renal arteries. A dose of 0.1 mmol/kg of body weight appears to be the most suitable.

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