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Diagnostic Efficacy and Safety of Gadoxetate Disodium vs Gadobenate Dimeglumine in Patients With Known or Suspected Focal Liver Lesions: Results of a Clinical Phase III Study.
- Source :
-
Magnetic resonance insights [Magn Reson Insights] 2019 Feb 18; Vol. 12, pp. 1178623X19827976. Date of Electronic Publication: 2019 Feb 18 (Print Publication: 2019). - Publication Year :
- 2019
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Abstract
- Purpose: The aim of this study is to evaluate the diagnostic efficacy and safety of gadoxetate disodium vs gadobenate dimeglumine in patients with known or suspected focal liver lesions.<br />Methods: This was a prospective, multicenter, double-blind, randomized, inter-individual Phase III study. The primary target-technical efficacy-was already published. Here, secondary efficacy parameters-sensitivity and specificity-and safety in specific patient populations are presented. Patients with suspected or known focal liver lesions scheduled for contrast-enhanced liver magnetic resonance imaging (MRI) were recruited and categorized in 4 a priori specified subgroups: (1) all patients, (2) patients with liver cancer (hepatocellular carcinoma [HCC]), (3) patients with cirrhosis, and (4) patients with HCC + cirrhosis. Dual multi-detector liver computed tomography (CT) served as standard of reference.<br />Results: A total of 295 patients were included. While the overall increase in sensitivity across all 4 patient groups was comparable for gadoxetate disodium (increase from pre- to post-contrast ranging from 6.2% to 9.9%) and gadobenate dimeglumine (ranging from -2.9% to 10.0%), significant differences were seen for some of the subgroups. There was a significantly higher increase in sensitivity for gadoxetate disodium in patients with HCC (7%) and HCC + cirrhosis (12.8%) in comparison with gadobenate dimeglumine. Specificity decreased for both agents: gadoxetate disodium by -2.8% to -6.3% and gadobenate dimeglumine by -3.3% to -8.7%. Gadoxetate showed a significantly lower loss of specificity in all subgroups. Safety was comparable in both groups.<br />Conclusions: Gadoxetate disodium proved to be an effective liver-specific MRI contrast agent. Some distinct advantages over gadobenate dimeglumine were demonstrated in patients with HCC and patients with HCC + liver cirrhosis for sensitivity and specificity in liver lesion detection.<br />Competing Interests: Declaration of conflicting interests:The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Details
- Language :
- English
- ISSN :
- 1178-623X
- Volume :
- 12
- Database :
- MEDLINE
- Journal :
- Magnetic resonance insights
- Publication Type :
- Academic Journal
- Accession number :
- 30799932
- Full Text :
- https://doi.org/10.1177/1178623X19827976