Gadoxetic-enhanced abbreviated MRI versus dynamic CT for monitoring recurrence after curative HCC treatment

A Prospective Multicenter Study for the Intra-Individual Comparison of Abbreviated MRI Using Gadoxetic Acid and Dynamic CT for Surveillance of Recurrent HCC After Curative Treatment

This trial tests whether abbreviated MRI with gadoxetic acid or dynamic CT is better at finding recurrent hepatocellular carcinoma in people who have been cancer-free for at least two years after curative treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 455 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Asan Medical Center (other)
• Drugs / interventions: radiation
• Locations: 1 site (Seoul, Songpa-gu , 88, Olympic-ro 43-gil)
• Trial ID: NCT06537193 on ClinicalTrials.gov

What this trial studies

This prospective study will enroll 455 participants who have been recurrence-free for more than two years after curative surgery or ablation and undergo two rounds of both abbreviated MRI (AMRI) with gadoxetic acid and dynamic CT roughly 4–8 months apart. If a suspicious lesion is found, a recall full MRI will be performed within three months, and indeterminate cases will undergo contrast-enhanced ultrasound or biopsy for confirmation; diagnoses follow histology or LI-RADS 5 criteria. Participants will be followed for at least six months after the second imaging round to record interval cancers. If HCC is confirmed at any point, the participant leaves the surveillance protocol and receives standard-of-care treatment.

Who should consider this trial

Good fit: Adults over 20 who have been free of HCC recurrence for more than two years after curative surgery or ablation, with ECOG performance status 0–2, adequate renal function, and no prior systemic, radiation, or trans-arterial chemoembolization for HCC.

Not a fit: Patients with Child-Pugh class C liver disease, eGFR <30 mL/min/1.73m², prior severe iodine-contrast allergy, active other cancers with high short-term recurrence risk, or expected survival under three years are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could maintain or improve early detection of recurrent HCC while reducing cumulative radiation exposure and iodine-contrast use by supporting abbreviated MRI as a surveillance option.

How similar studies have performed: Smaller retrospective and prospective studies suggest abbreviated MRI can approach full MRI sensitivity and may outperform CT for HCC detection, but large prospective head-to-head comparisons are still limited.

Eligibility criteria

Inclusion Criteria:

1. Patients with more than two years without recurrence after curative treatment (surgery or local ablation) for HCC
2. Patients with no history of systemic treatment, radiation therapy, or trans-arterial chemoembolization for HCC
3. Older than 20 years of age
4. Eastern Cooperative Oncology Group performance status of 0-2
5. Patient is able to comply with scheduled visits, evaluation plans, and other study procedures
6. Patient is willing to provide written informed consent

Exclusion Criteria:

1. Active or suspected cancer, or a history of malignancy where the risk of recurrence is equal or higher than 20% within 2 years.
2. Significant medical comorbidities in which survival is predicted to be less than 3 years
3. Estimated glomerular filtration rate \< 30 mL/min/1.73m²
4. Child-Pugh class C
5. Patient not eligible for applying LI-RADS criteria, such as Budd-Chiari Syndrome
6. Previous history of severe allergic reaction to iodine contrast medium
7. Precautions for MRI (cardiac pacemaker, severe claustrophobia that may interfere with protocol compliance).
8. Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with completing the study.

Where this trial is running

Seoul, Songpa-gu , 88, Olympic-ro 43-gil

• Asan Medical Center — Seoul, Songpa-gu , 88, Olympic-ro 43-gil, South Korea (RECRUITING)

Study contacts

• Principal investigator: So Yeon Kim, MD, PhD — Asan Medical Center
• Study coordinator: So Yeon Kim, MD, PhD

Conditions: Hepatocellular Carcinoma, Abbreviated MRI, Dynamic CT