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.

Christoph J Zech,Carsten Schwenke,Jan Endrikat

doi:10.1177/1178623x19827976

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.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.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.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.

Highlights

Liver cancer is an increasing global problem
A total of 295 patients were included in 16 centers in 6 European countries (Germany, Austria, Italy, Sweden, the United Kingdom, and France)
More patients in the gadoxetate disodium group showed imaging signs of diffuse liver disease compared with the gadobenate dimeglumine group, 60 (41.1%) and 41 (27.5%), respectively (Table 2). Both patient groups differed with respect to the primary suspected liver lesion

Summary

Introduction

Liver cancer is an increasing global problem. In the United States, the incidence has tripled over the past 20 to 30 years and is at 7 per 100 000 Americans.[1] Early detection and accurate characterization of liver lesions are crucial for successful therapy and overall survival of patients. Non-invasive diagnostic tools, eg, ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI), are used worldwide. MRI in combination with liver-specific gadolinium (Gd)-based contrast agents (GBCAs) is a valuable option as no radiation is involved. In comparison with CT or to conventional MRI with extracellular contrast agent, MRI with liver-specific gadoxetate disodium has been shown to be a promising diagnostic tool for the detection of colorectal liver metastases[2] or hepatocellular carcinoma (HCC).[3]

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