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Ricke, Jens; Steffen, Ingo G.; Bargellini, Irene; Berg, Thomas; Bilbao Jaureguizar, Jose Ignacio; Gebauer, Bernhard; Iezzi, Roberto; Loewe, Christian; Karcaaltincaba, Musturay; Pech, Maciej; Sengel, Christian; Delden, Otto van; Vandecaveye, Vincent; Zech, Christoph J. und Seidensticker, Max (2020): Gadoxetic acid-based hepatobiliary MRI in hepatocellular carcinoma. In: Jhep Reports, Bd. 2, Nr. 6, 100173

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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. (C) 2020 The Author(s). Published by Elsevier B.V. on behalf of European Association for the Study of the Liver (EASL).

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