Abbreviated gadoxetic acid-enhanced MRI versus ultrasonography for HCC surveillance in high-risk patients: A
Hyo Jung Park1, Jonggi Choi2, Dong Wook Kim1
1Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Background:
Although ultrasonography (US) is widely recommended for HCC surveillance, its limited sensitivity for early-stage HCC remains a concern. Gadoxetic acid-enhanced abbreviated MRI (HBP-AMRI) has demonstrated high diagnostic performance; however, its role in routine surveillance settings remains uncertain due to limited prospective comparative evidence. The AMRIUS study (Abbreviated MRI using gadoxetic acid versus Ultrasonography for Surveillance of early-stage HCC in high-risk patients) aims to prospectively compare the effectiveness of HBP-AMRI and US for HCC surveillance in high-risk patients with cirrhosis.
Methods:
AMRIUS is a randomized controlled trial (RCT) enrolling 806 high-risk patients with cirrhosis, randomly assigned (1:1) to undergo either biannual HBP-AMRI or US for 2 surveillance rounds. The primary endpoint is the detection rate of early-stage HCC [Barcelona Clinic Liver Cancer (BCLC) stage 0 or A]. Secondary endpoints include false referral rate of BCLC 0 or A HCC, detection and false referral rates for BCLC stage 0 and all-stage HCC, BCLC stage distribution at initial HCC diagnosis, and the rate of curative treatment. Structured imaging protocols and quality assessments will be implemented.
Discussion:
AMRIUS is the first RCT designed to provide high-level evidence comparing HBP-AMRI and US for HCC surveillance. Its findings are expected to inform future guidelines and support risk-adapted strategies that prioritize early detection and curative treatment eligibility, particularly for patients likely to benefit from high-sensitivity imaging.
Trial Registration:
Registered at Clinical Research Information Service on May 22, 2022 (KCT0007417) and ClinicalTrials.gov on March 9, 2024 (NCT06312826). Participant recruitment began on August 26, 2022. Follow-up is ongoing.
