Gadoxetic Acid-Based MRI for Decision-Making in Hepatocellular Carcinoma Employing Perfusion Criteria Only-A Post Hoc Analysis from the SORAMIC Trial Diagnostic Cohort.

Max Seidensticker,Thomas Berg,Musturay Karçaaltincaba,Christoph J Zech,Jens Ricke,Irene Bargellini,Christian Sengel,Vincent Vandecaveye,Christian Loewe,Roberto Iezzi,Maciej Pech,Ingo G Steffen,Otto Van Delden,Bernhard Gebauer,Alberto Benito

doi:10.3390/curroncol29020051

Abstract

The value of gadoxetic acid in the diagnosis of hepatocellular carcinoma (HCC), based on perfusion criteria, is under dispute. This post-hoc analysis of the prospective, phase II, randomized, controlled SORAMIC study compared the accuracy of gadoxetic acid-enhanced dynamic magnetic resonance imaging (MRI) (arterial, portovenous, and venous phase only) versus contrast-enhanced computed tomography (CT) for stratifying patients with HCC to curative ablation or palliative treatment. Two reader groups (radiologists, R1 and R2) performed blind reads of CT and gadoxetic acid-enhanced MRI (contrast dynamics only). A truth panel, with access to clinical and imaging follow-up data, served as reference. Primary endpoint was non-inferiority (margin: 5% points) of MRI vs. CT (lower 95% confidence interval [CI] > 0.75) in a first step and superiority (complete 95% CI > 1) in a second step. The intent-to-treat population comprised 538 patients. Accuracy of treatment decisions was 73.4% and 70.8% for CT (R1 and R2, respectively) and 75.1% and 70.3% for gadoxetic acid-enhanced dynamic MRI. Non-inferiority but not superiority of gadoxetic acid-enhanced dynamic MRI versus CT was demonstrated (odds ratio 1.01; CI 0.97–1.05). Despite a theoretical disadvantage in wash-out depiction, gadoxetic acid-enhanced dynamic MRI is non-inferior to CT in accuracy of treatment decisions for curative ablation versus palliative strategies. This outcome was not subject to the use of additional MR standard sequences.

Highlights

Hepatocellular carcinoma (HCC) represents approximately 80–90% of all liver cancers [1]
Interreader agreement between the reader groups was moderate for computed tomography (CT) (Cohen’s kappa: 0.58 [95% confidence interval (CI) 0.51–0.66], reader group 1 (R1) vs. reader group 2 (R2), ITT) and substantial for dynamic magnetic resonance imaging (MRI) (0.67 [95% CI 0.61–0.74])
Results for the PP population were comparable between dynamic MRI and CT at 0.73 and 0.61, respectively

Summary

Introduction

Hepatocellular carcinoma (HCC) represents approximately 80–90% of all liver cancers [1]. The theoretical rationale for excluding HBI criteria in Western guidelines is that uptake of gadoxetic acid early in the venous phase (resulting in a so-called transitional phase), in the surrounding liver parenchyma, may lead to a wash-out characterization of lesions besides perfusion-related factors only and, decrease specificity [4,5]. This technical consideration has not been reproduced, so far, in a prospective trial incorporating a clinically meaningful study endpoint, such as treatment decision-making

Methods

Results

Conclusion