Gadoxetic acid-based hepatobiliary MRI in hepatocellular carcinoma

Jens Ricke, Ingo G. Steffen, Irene Bargellini, Thomas Berg, José Ignacio Bilbao Jaureguizar, Bernhard Gebauer, Roberto Iezzi, Christian Loewe, Musturay Karçaaltincaba, Maciej Pech, Christian Sengel, Otto van Delden, Vincent Vandecaveye, Christoph J. Zech, Max Seidensticker

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Abstract

Background & Aims: SORAMIC is a prospective phase II randomised controlled trial in hepatocellular carcinoma (HCC). It consists of 3 parts: a diagnostic study and 2 therapeutic studies with either curative ablation or palliative Yttrium-90 radioembolisation combined with sorafenib. We report the diagnostic cohort study aimed to determine the accuracy of gadoxetic acid-enhanced magnetic resonance imaging (MRI), including hepatobiliary phase (HBP) imaging features compared with contrast-enhanced computed tomography (CT). The primary objective was the accuracy of treatment decisions stratifying patients for curative or palliative (non-ablation) treatment. Methods: Patients with clinically suspected HCC underwent gadoxetic acid-enhanced MRI (HBP MRI, including dynamic MRI) and contrast-enhanced CT. Blinded read of the image data was performed by 2 reader groups (radiologists, R1 and R2). A truth panel with access to all clinical data and follow-up imaging served as reference. Imaging criteria for curative ablation were defined as up to 4 lesions <5 cm and absence of macrovascular invasion. The primary endpoint was non-inferiority of HBP MRI vs. CT in a first step and superiority in a second step. Results: The intent-to-treat population comprised 538 patients. Treatment decisions matched the truth panel assessment in 83.3% and 81.2% for HBP MRI (R1 and R2), and 73.4% and 70.8% for CT. Non-inferiority and superiority (second step) of HBP MRI vs. CT were demonstrated (odds ratio 1.14 [1.09–1.19]). HBP MRI identified patients with >4 lesions significantly more frequently than CT. Conclusions: In HCC, HBP MRI provided a more accurate decision than CT for a curative vs. palliative treatment strategy. Lay summary: Patients with hepatocellular carcinoma are allocated to curative or palliative treatment according to the stage of their disease. Hepatobiliary imaging using gadoxetic acid-enhanced MRI is more accurate than CT for treatment decision-making.
Original languageEnglish
Article number100173
JournalJHEP Reports
Volume2
Issue number6
DOIs
Publication statusPublished - 1 Dec 2020

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