Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT06537193

Abbreviated MRI Using Gadoxetic Acid Versus CT for Surveillance of Recurrent HCC After Curative Treatment

Led by Asan Medical Center · Updated on 2026-03-10

455

Participants Needed

1

Research Sites

211 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Hepatocellular carcinoma (HCC) often has a poor prognosis after curative treatment due to frequent recurrence. Post-surgery, 60-70% of HCC patients experience recurrence, rising to 80% after ablation therapy. This is partly because underlying cirrhosis or chronic liver disease remains, increasing the risk of secondary HCC. The risk of recurrence varies over time, with a high risk in the first two years due to micro-metastasis. Later recurrences are usually new primary cancers (de novo HCC). Therefore, regular imaging tests, such as computed tomography (CT) or magnetic resonance imaging (MRI) every three months in the first two years, are necessary for early detection, but guidelines for post-two-year screenings are unclear. Currently, for patients recurrence-free for two years, contrast-enhanced liver CT or MRI is performed every 3-6 months as a secondary screening test. However, repeated use of CT raises concerns about radiation exposure and iodine-based contrast agents can lead to side effects and kidney issues. MRI with hepatocyte-specific agents like gadoxetic acid (Primovist) is effective but costly and time-consuming, with potential side effects from repeated gadolinium exposure. Therefore, there is a need for a validated secondary screening method that is both effective and reduces patient risk. Abbreviated contrast-enhanced MRI, using only essential sequences, has shown promise in retrospective studies for detecting HCC. However, these studies have limitations, such as potential bias and lack of data on repeated screenings. There is limited research on secondary screening post-curative treatment for HCC. This study aims to prospectively evaluate the use of abbreviated contrast-enhanced MRI with Primovist as a secondary screening method for detecting secondary HCC in patients who have been recurrence-free for more than two years.

CONDITIONS

Official Title

Abbreviated MRI Using Gadoxetic Acid Versus CT for Surveillance of Recurrent HCC After Curative Treatment

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with more than two years without recurrence after curative treatment (surgery or local ablation) for HCC
  • No history of systemic treatment, radiation therapy, or trans-arterial chemoembolization for HCC
  • Age 20 years or older
  • Eastern Cooperative Oncology Group performance status of 0-2
  • Ability to follow scheduled visits, evaluations, and study procedures
  • Willingness to provide written informed consent
Not Eligible

You will not qualify if you...

  • Active or suspected cancer or history of malignancy with a recurrence risk of 20% or higher within 2 years
  • Serious medical conditions predicting survival less than 3 years
  • Estimated glomerular filtration rate less than 30 mL/min/1.73m²
  • Child-Pugh class C liver disease
  • Ineligibility for LI-RADS criteria application, such as Budd-Chiari Syndrome
  • Previous severe allergic reaction to iodine contrast medium
  • Conditions preventing MRI use, including cardiac pacemaker or severe claustrophobia
  • Any other condition deemed by the investigator to interfere with study participation or completion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Asan Medical Center

Seoul, Songpa-gu , 88, Olympic-ro 43-gil, South Korea, 05505

Actively Recruiting

Loading map...

Research Team

S

So Yeon Kim, MD, PhD

CONTACT

H

Hyo Jung Park, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here