Alternative Surveillance Program for Patients With High Risk Group of HCC

May 13, 2025 updated by: Jeong Hee Yoon, Seoul National University Hospital

Alternative Surveillance Program for Prospective Cohort of a Super-high Risk Group of Developing HCC

In a high-risk group, ultrasonography at 6-month intervals and short-protocol magnetic resonance imaging at 1-year intervals were performed. sensitivity, specificity, positive and negative predictive values for very early stage HCC are compared between conventional (biannual US) and alternative surveillance test are compared

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

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

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • chronic hepatitis B or C
  • Child-Pugh classification A
  • HCC risk score >= -2.04
  • have not diagnosed with HCC
  • on surveillance program using US and negative on previous US within 6-8 months of enrollment
  • sign informed consent

Exclusion Criteria:

  • younger than 40 years or older than 70 years old
  • history of HCC
  • severe GFR or on HD/PD due to renal failure
  • contra-indication of MRI
  • congestive hepatopathy
  • iron deposition
  • pregnancy or nursing mother
  • non-viral hepatitis or liver cirrhosis

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: US & MRI
All participants undergo biannual US (as a part of standard-of-care) and annual non-contrast focused MRI.
Diagnostic test: Non-contrast focused MRI
non-contrast liver MRI focusing on HCC surveillance in a short scan time.
Other Names:
  • Abbreviated MRI
  • Focused MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of alternative surveillance program (alternating focused MRI + US in 6 month interval) and conventional surveillance (biannual US) for HCC detection
Time Frame: up to one year
per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.
up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of annual focused MRI and biannual US for HCC detection
Time Frame: up to one year
per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.
up to one year
diagnostic yield for HCC
Time Frame: up to one year
HCC incidence in the group and detection rate with either US or focused MRI
up to one year
scan time of focused MRI
Time Frame: up to one month
in room time, table time are manually recorded
up to one month
comparison between false referral rates of biannual US and annual focused MRI
Time Frame: up to one year
comparison between false positive report/finding for HCC in each surveillance modality.
up to one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison between incidental findings between biannual US and annual focused MRI
Time Frame: up to one year
comparison of incidental findings detected between biannual US and annual focused MRI.
up to one year

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

Korea University Guro Hospital
The Catholic University of Korea
Severance Hospital

Investigators

  • Principal Investigator: Jeong Hee Yoon, MD, Seoul National University Hospital

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)

January 6, 2023

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 10, 2022

First Submitted That Met QC Criteria

December 10, 2022

First Posted (Actual)

December 20, 2022

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-2021-1084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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