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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

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Authors
Kim, Hyun A; Kim, Kyung Ah; Choi, Joon-Il; Lee, Jeong Min; Lee, Chang Hee; Kang, Tae Wook; Ku, Young-Mi; Lee, Su Lim; Park, Yang Shin; Yoon, Jeong Hee; Kim, Seong Hyun; Choi, Moon Hyung
Issue Date
2017-12-21
Publisher
BioMed Central
Citation
BMC Cancer, 17(1):877
Keywords
Hepatocellular carcinomaLiver cirrhosisUltrasonographyMagnetic resonance imagingSurveillance
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.
ISSN
1471-2407
Language
English
URI
http://hdl.handle.net/10371/138457
DOI
https://doi.org/10.1186/s12885-017-3819-y
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College of Medicine/School of Medicine (의과대학/대학원)Radiology (영상의학전공)Journal Papers (저널논문_영상의학전공)
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