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
Vm. Runge et Cm. Kenney, 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, J MAGN R I, 11(6), 2000, pp. 655-664
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.