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Seidensticker, Max; Steffen, Ingo G.; Bargellini, Irene; Berg, Thomas; Benito, Alberto; Gebauer, Bernhard; Iezzi, Roberto; Loewe, Christian; Karcaaltincaba, Musturay; Pech, Maciej; Sengel, Christian; Delden, Otto van; Vandecaveye, Vincent; Zech, Christoph J. und Ricke, Jens (2022): Gadoxetic Acid-Based MRI for Decision-Making in Hepatocellular Carcinoma Employing Perfusion Criteria Only-A Post Hoc Analysis from the SORAMIC Trial Diagnostic Cohort. In: Current Oncology, Bd. 29, Nr. 2: S. 565-577 [PDF, 1MB]

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.

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