Focal liver lesions: Evaluation of the efficacy of gadobenate dimeglumine in MR imaging - A multicenter phase III clinical study

PURPOSE: To evaluate gadobenate dimeglumine (Cd-BOPTA) for dynamic and dela yed magnetic resonance (MR) imaging of focal liver lesions. MATERIALS AND METHODS: In 126 of 214 patients, MR imaging was performed bef ore Cd-BOPTA administration, immediately after bolus administration of a 0. 05-mmol/kg dose of Cd-BOPTA, and 60-120 minutes after an additional intrave nously infused 0.05-mmol/kg dose. In 88 patients, imaging was performed bef ore and 60-120 minutes after a single, intravenously infused 0.1-mmol/kg do se. T1- and T2-weighted spin-echo and T1-weighted gradient-echo images were acquired. On-site and blinded off-site reviewers prospectively evaluated a ll images. Intraoperative ultrasonography, computed tomography (CT) during arterial portography, and/or CT with iodized oil served as the reference me thods in 110 patients. RESULTS: Significantly more lesions were detected on combined pre- and post contrast images compared with on precontrast images alone (P < .01). All re viewers reported a decreased mean size of the smallest detected lesion and improved lesion conspicuity on postcontrast images. All on-cite reviewers a nd two off-site reviewers reported increased overall diagnostic confidence (P < .01). Additional lesion characterization information was provided on u p to 109 (59%) of 184 delayed images and for up to 50 (42%) of 118 patients in whom dynamic images were assessed. Cd-BOPTA would have helped change th e diagnosis in 99 (47%) of 209 cases and affected patient treatment in 408 (23%) of 209 cases. CONCLUSION: Cd-BOPTA increases liver lesion conspicuity and detectability a nd aids in the characterization of lesions.