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

doi:10.1016/j.jhepr.2020.100173

Gadoxetic acid-based hepatobiliary MRI in hepatocellular carcinoma

JHEP Rep. 2020 Aug 24;2(6):100173. doi: 10.1016/j.jhepr.2020.100173. eCollection 2020 Dec.

Authors

Affiliations

¹ Department of Radiology, Ludwig-Maximilians-University Munich, Munich, Germany.
² Department of Interventional Radiology, Pisa University Hospital, Pisa, Italy.
³ Klinik und Poliklinik für Gastroenterologie, Sektion Hepatologie, Universitätsklinikum Leipzig AöR, Leipzig, Germany.
⁴ Department of Radiology, Clínica Universidad de Navarra, Pamplona, Spain.
⁵ Department of Radiology, Charité-Universitätsmedizin Berlin, Berlin, Germany.
⁶ Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Radiologia, Rome, Italy.
⁷ Section of Cardiovascular and Interventional Radiology, Department of Bioimaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.
⁸ Department of Radiology, Hacettepe University School of Medicine, Ankara, Turkey.
⁹ Department of Radiology and Nuclear Medicine, University of Magdeburg, Magdeburg, Germany.
¹⁰ Radiologie interventionnelle vasculaire et percutanée, CHU de Grenoble, Grenoble, France.
¹¹ Department of Radiology and Nuclear Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
¹² Department of Radiology, University Hospitals Leuven, Leuven, Belgium.
¹³ Radiology and Nuclear Medicine, University Hospital Basel, University of Basel, Basel, Switzerland.

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.

Keywords: APASL, Asian Pacific Association for the Study of the Liver; BCLC, Barcelona Clinic Liver Cancer; CT, computed tomography; DWI, diffusion-weighted imaging; GEE, generalised estimating equation; GRE, gradient echo; Gadoxetic acid; HBP, hepatobiliary phase; HCC, hepatocellular carcinoma; HGDN, high-grade dysplastic nodule; Hepatocellular carcinoma; ITT, intent to treat; MRI, magnetic resonance imaging; Magnetic resonance imaging; OR, odds ratio; PP, per protocol; RFA, radio-frequency ablation; SORAMIC trial; SORAMIC, Sorafenib and Micro-Therapy Guided by Gadolinium-EOB-DTPA-Enhanced MRI; TSE, turbo spin echo.