Journal Article

Noncontrast magnetic resonance imaging versus ultrasonography for hepatocellular carcinoma surveillance (MIRACLE-HCC): study protocol for a prospective randomized trial

Kim, Do Young, Roh, Yun Ho, Choi, Jin-Young, Kim, Myeong-Jin, An, Chansik, Han, Kwang Hyub

2018

Overview

Background Biannual ultrasound (US)—with or without alpha-fetoprotein (AFP)—is recommended by current guidelines for the surveillance of hepatocellular carcinoma (HCC). However, the inadequate sensitivity of US has been a concern. Magnetic resonance imaging (MRI) is known to have high sensitivity in detecting hepatic malignancies, even without contrast enhancement. The purpose of our study is to compare US with noncontrast (unenhanced) MRI for HCC surveillance of high-risk patients. Methods/design MIRACLE-HCC (usefulness of noncontrast MagnetIc Resonance imAging versus nonContrast ultrasonography for surveiLlancE of HepatoCellular Carcinoma) is a prospective, single-center, nonblinded, balanced-randomized, parallel-group study. This study was approved by our institutional review board, and informed consent will be obtained from all participating patients. All patients with compensated liver cirrhosis will undergo noncontrast US or MRI, with serum AFP testing every 6 months. If a suspicious lesion is newly detected, or if the serum AFP level is elevated in an increasing trend for two consecutive tests, dynamic contrast-enhanced imaging will be performed to confirm the diagnosis. The primary endpoints are detection rates of very early or early stage HCC, stage distribution at the initial diagnosis, and false positive referral rates, which will be compared using Fisher’s exact or chi-square tests. The study will include 416 patients in a tertiary academic medical center in South Korea. Discussion MIRACLE-HCC is the first prospective randomized trial to compare the effectiveness of noncontrast MRI and noncontrast US in the surveillance of HCC in at-risk patients. The results of this trial will show whether noncontrast MRI surveillance is superior to noncontrast US surveillance in the early detection of HCC. The trial will also determine whether there are fewer false referrals with noncontrast MRI than with noncontrast US and, eventually, whether there is improvement in the overall survival of HCC patients. Trial registration The date of trial registration (ClincalTrials.gov: NCT02514434 ) for this study is July 23, 2015. Enrollment of participants was finished in November 2017. No authors have relationships, conditions, or circumstances that present potential conflicts of interest.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Biomarkers, Tumor / Biomedical and Life Sciences / Biomedicine / cancer imaging / Cancer Research / Carcinoma, Hepatocellular - diagnostic imaging / Carcinoma, Hepatocellular - epidemiology / Carcinoma, Hepatocellular - metabolism / Care and treatment / Cirrhosis / Clinical medicine / Clinical Protocols / Comparative analysis / Diagnosis / Early Detection of Cancer - methods / FDA approval / Health Promotion and Disease Prevention / Hepatocellular carcinoma / Humans / interventional therapeutics / Liver cancer / Liver cirrhosis / Liver Neoplasms - diagnostic imaging / Liver Neoplasms - epidemiology / Liver Neoplasms - metabolism / Magnetic resonance imaging / Magnetic Resonance Imaging - methods / Mass Screening - methods / Medical imaging / Medicine/Public Health / Mortality / NMR / Nuclear magnetic resonance / Oncology / Patients / Population Surveillance / Registration / Risk factors / Risk groups / Study Protocol / Surgical Oncology / Surveillance / Ultrasonic imaging / Ultrasonography / Ultrasonography - methods / Ultrasound / Ultrasound imaging / Workflow / α-Fetoprotein