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

Research output: Contribution to journalArticle

3 Citations (Scopus)

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 6months and non-contrast liver MRI every 12months during a follow-up period of 3years. 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.

Original languageEnglish
Article number877
JournalBMC Cancer
Volume17
Issue number1
DOIs
Publication statusPublished - 2017 Dec 21

Fingerprint

Liver Cirrhosis
Hepatocellular Carcinoma
Ultrasonography
Magnetic Resonance Imaging
Liver
Tomography
Survival
Research Ethics Committees
Informed Consent
Cross-Over Studies
Multicenter Studies
Clinical Trials

Keywords

  • Hepatocellular carcinoma
  • Liver cirrhosis
  • Magnetic resonance imaging
  • Surveillance
  • Ultrasonography

ASJC Scopus subject areas

  • Oncology
  • Genetics
  • Cancer Research

Cite this

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. / 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.

In: BMC Cancer, Vol. 17, No. 1, 877, 21.12.2017.

Research output: Contribution to journalArticle

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. / 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. In: BMC Cancer. 2017 ; Vol. 17, No. 1.
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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 6months and non-contrast liver MRI every 12months during a follow-up period of 3years. 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.",
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T2 - A study protocol

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AU - Kim, Kyung Ah

AU - Choi, Joon Il

AU - Lee, Jeong Min

AU - Lee, Chang-Hee

AU - Kang, Tae Wook

AU - Ku, Young Mi

AU - Lee, Su Lim

AU - Park, Yang Shin

AU - Yoon, Jeong Hee

AU - Kim, Seong Hyun

AU - Choi, Moon Hyung

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N2 - 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 6months and non-contrast liver MRI every 12months during a follow-up period of 3years. 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.

AB - 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 6months and non-contrast liver MRI every 12months during a follow-up period of 3years. 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.

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KW - Magnetic resonance imaging

KW - Surveillance

KW - Ultrasonography

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