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

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

Abstract

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.

Keywords: Hepatocellular carcinoma; Magnetic resonance imaging; Surveillance; Ultrasonography.

Conflict of interest statement

Ethics approval and consent to participate

This study has been approved by our institutional review board (Severance Hospital, Yonsei University College of Medicine; e-IRB: http://eirb.yuhs.ac; IRB number: 4–2015-0029). Any modifications to the protocol will be implemented only after they are approved by the IRB and notified to all participating investigators and patients. We obtained informed written consent to participate in this study from all participating patients. The translated version of the model informed consent form is provided as an additional document (see Additional file 1).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participant flow

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