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OpenTrials
Active, Not Recruiting

NCT Number: NCT05657249

Alternative Surveillance Program for Patients With High Risk Group of 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-contrast focused MRI

Diagnostic Test

non-contrast liver MRI focusing on HCC surveillance in a short scan time.

Other names: Focused MRI, Abbreviated MRI

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. diagnostic yield for HCC

    Time frame: up to one year

    HCC incidence in the group and detection rate with either US or focused MRI

  3. scan time of focused MRI

    Time frame: up to one month

    in room time, table time are manually recorded

  4. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Korea University Guro Hospital
  • Severance Hospital
  • The Catholic University of Korea

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2022
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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