Phase II double-blind, dose-ranging clinical evaluation of gadobenate dimeglumine in focal liver lesions: With analysis of liver and kidney signal change on early and delayed imaging

To evaluate the effect of contrast dose using gadobenate dimeglumine, 30 pa tients with focal liver lesions documented by computed tomography or ultras ound were studied by magnetic resonance imaging at 1.5 T. Patients received one of four doses of gadobenate dimeglumine (0.025, 0.05, 0.1, or 0.2 mmol /kg) or saline. The order of dosage was randomized, with both the physician and patient blinded to the administered dose. Scans were obtained before, immediately following injection, and after So minutes of delay. Enhancement effects were quantified by region of interest measurements. Films were als o reviewed in a randomized prospective fashion by an abdominal radiologist blinded to contrast dose and diagnosis. Higher doses led to a statistically significant improvement in enhancement of normal liver, both on immediate (P = 0.01 for the comparison of 0.1 and 0.2 mmol/kg immediately post-contra st) and delayed scans (P = 0.003 for the same comparison). Liver-lesion con trast-to-noise ratio also increased with dose, although results for most co mparisons by dose were not statistically significant. Scans following gadob enate dimeglumine injection were judged to provide additional diagnostic co nfidence sufficient to affect patient management in 10 of 24 cases. In seve n cases this information was provided by dynamic scans, in one case by dela yed scans, and in two cases by both dynamic and delayed scans. In 2 of the 10 cases the dose was 0.025 mmol/kg, in 2 cases 0.05 mmol/kg, in 3 cases 0. 1 mmol/kg, and in 3 cases 0.2 mmol/kg. Gadobenate dimeglumine is effective for imaging of focal liver lesions at a range of doses, with trends toward improved diagnostic information at higher doses. J. Magn. Reson. Imaging 20 00;11:655-664. (C) 2000 Wiley-Liss, Inc.