Comparison of biannual ultrasonography and annual non-contrast liver magnetic resonance imaging as surveillance tools for hepatocellular carcinoma in patients with liver cirrhosis (MAGNUS-HCC): a study protocol

Hyun A Kim, Kyung Ah Kim, Joon-Il Choi, Jeong Min Lee, Chang Hee Lee, Tae Wook Kang, Young-Mi Ku, Su Lim Lee, Yang Shin Park, Jeong Hee Yoon, Seong Hyun Kim, Moon Hyung Choi, Hyun A Kim, Kyung Ah Kim, Joon-Il Choi, Jeong Min Lee, Chang Hee Lee, Tae Wook Kang, Young-Mi Ku, Su Lim Lee, Yang Shin Park, Jeong Hee Yoon, Seong Hyun Kim, Moon Hyung Choi

Abstract

Background: Ultrasonography (US) is recommended as a standard surveillance tool for patients with a high risk of developing hepatocellular carcinoma (HCC). However, the low sensitivity of US for small HCC can lead to surveillance failure, resulting in advanced stage tumor presentations. For the early detection of HCC in high-risk patients and to improve survival and prognosis, a new efficient imaging tool with a high sensitivity for HCC detection is needed. The purpose of this study is to evaluate and compare the feasibility and efficacy of non-contrast magnetic resonance imaging (MRI) with US as a surveillance tool for HCC in patients with liver cirrhosis.

Methods: MAGNUS-HCC is a prospective, multicenter clinical trial with a crossover design for a single arm of patients. This study was approved by six Institutional Review Boards, and informed consent was obtained from all participants. All patients will undergo liver US every 6 months and non-contrast liver MRI every 12 months during a follow-up period of 3 years. If a focal liver lesion suspected of harboring HCC is detected, dynamic liver computed tomography (CT) will be performed to confirm the diagnosis. After the last surveillance round, patients without suspicion of HCC or who are not diagnosed with HCC will be evaluated with a dynamic liver CT to exclude false-negative findings. The primary endpoint is to compare the rate of detection of HCC by US examinations performed at 6-month intervals with that of yearly non-contrast liver MRI studies during a 3-year follow-up. The secondary endpoint is the survival of the patients who developed HCC within the 3-year follow-up period.

Discussion: MAGNUS-HCC is the first study to compare the feasibility of non-contrast MRI with US as a surveillance tool for the detection of HCC in high-risk patients. We anticipate that the evidence presented in this study will establish the efficacy of non-contrast MRI as a surveillance tool for HCC in high-risk patients.

Trial registration: The date of trial registration ( NCT02551250 ) in this study was September 15, 2015, and follow-up is still ongoing.

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

Conflict of interest statement

Ethics approval and consent to participate

The study will include 211 patients under surveillance for HCC in six medical institutions (Seoul St. Mary’s Hospital, St. Vincent’s Hospital, Uijeongbu St. Mary’s Hospital, Seoul National University Hospital, Samsung Medical Center, and Korea University Guro Hospital) in Republic of Korea. This study was approved by six Institutional Review Boards of the ethical committee of Seoul St. Mary’s Hospital, The Catholic University of Korea, the ethical committee of St. Vincent’s Hospital, The Catholic University of Korea, the ethical committee of Uijeongbu St. Mary’s Hospital, The Catholic University of Korea, the ethical committee of Seoul National University Hospital, the ethical committee of Samsung Medical Center and the ethical committee of Korea University Guro Hospital), and written informed consent was obtained from all human participants.

Consent for publication

We obtained consent for publication of these data (US images, non-contrast MRI, laboratory findings, age, gender) from all participating patients.

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
Flow chart providing an overview of the study design. US, ultrasonography; MRI, magnetic resonance imaging; AFP, α fetoprotein; PIVKA-II, protein induced by vitamin K absence/antagonist II; CT, computed tomography
Fig. 2
Fig. 2
Timeline for follow-up tests. US, ultrasonography; MRI, magnetic resonance imaging; CT, computed tomography; AFP, α fetoprotein; PIVKA-II, protein induced by vitamin K absence/antagonist II

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