Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis (MAGNUS-HCC)

September 17, 2019 updated by: JOON-IL CHOI

Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging as a Surveillance Test for Hepatocellular Carcinoma in Patients With Liver Cirrhosis

The investigators will investigate the usefulness of biannual ultrasonography versus annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in single arm patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hepatocellular carcinoma (HCC) is one of the major complications in patients with chronic liver disease. The prognosis of HCC relies on the extent of disease at the time of diagnosis. Hence to detect cancer at an earlier stage, a regular surveillance test is important for the subjects with a high risk of developing cancer. Current guidelines recommend a regular surveillance using ultrasonography (US) at a 6 month-interval. Ultrasonography is a non-invasive and safe procedure, yet it is limited by the skills of the operator and it is often difficult to differentiate cancer from regenerating nodules especially in atrophied cirrhotic liver. According to a recent meta-analysis, the overall sensitivity and specificity of detecting liver cancer using ultrasonography were both over 90%, however the sensitivity was decreased to 60% in detecting early lesions in which surgery or liver transplantation is indicated. Of note, addition of alpha feto protein(AFP) to ultrasonography also failed to increase the sensitivity in detecting small cancers. Taken together, there is a need to develop a new surveillance test with an improved sensitivity and specificity.

Recently, a retrospective study reported that CT or MRI showed a better sensitivity than ultrasonography in detecting early liver cancer. However, performing CT as a surveillance test is limited by frequent exposure to radiation and contrast-dye agent. Although MRI does not have the risk of radiation-exposure, it is limited by the high cost and limited availability. On the contrast, non-contrast MRI offers a cost that is comparable to US and an absence of exposure to radiation or contrast-dye agent, which suggests non-contrast MRI as a good alternative surveillance tool for early detection of HCC. Therefore, in this prospective trial, the investigators will investigate the usefulness of biannual ultrasonography versus annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma.

Study Type

Observational

Enrollment (Actual)

211

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 06591
        • Seoul St.Mary's Hospital
      • Seoul, Korea, Republic of
        • Korean University Guro Hospital
      • Suwon, Korea, Republic of
        • St.Vincent's Hospital
      • Uijeongbu, Korea, Republic of
        • Uijeongbu St.Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with the risk of annual HCC occurrence larger than 5%

Description

Inclusion Criteria:

  • Male or female subject older than 40 years of age at the enrollment
  • Fulfill below conditions A and B

A. The evidence of cirrhosis of any etiology within 12 months prior to screening Definition of cirrhosis by any of following methods

  1. Histologically by liver biopsy;

  2. Non-histologically by evidence of portal hypertension in the presence of chronic liver disease;

    • Evidence of portal hypertension, including any of followings;

      • The identification of splenomegaly on ultrasonography, CT, or MRI examinations with typical features of cirrhosis
      • The identification of esophageal or gastric varices on endoscopic examination

B. Risk Index larger than 2.33; Risk Index = 1.65 (if the prothrombin activity is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100,000/mm3) + 0.74 (if the presence of HCV is positive).

Exclusion Criteria:

  • Presence of liver cancer or other intrahepatic malignancy
  • Has a history of malignancy within previous 5 years
  • Is pregnant or breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study
Surveillance of HCC by biannual ultrasonography AND annual noncontrast MRI
Device: annual noncontrast MRI
liver MRI without contrast agents T2 weighted image, T1 in/out of phase, diffusion weighted images with b-values of 0, 500 mm2/s
Device: biannual ultrasonography
liver ultrasonography for HCC screening performed by experienced sonologists

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity for detecting HCC
Time Frame: 3 years
sensitivity for detecting HCC
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival of the patients who developed HCC on follow-up period
Time Frame: years
survival of the patients who developed HCC on follow-up period
years
false referral rate for HCC
Time Frame: 3 years
false referral rate for HCC
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JOON-IL CHOI

Collaborators

National Cancer Center, Korea
Samsung Medical Center
Seoul National University Hospital
Korea University Guro Hospital
The Catholic University of Korea

Investigators

  • Principal Investigator: Joon-Il Choi, Seoul st. mary's hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1520160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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