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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: sykim.radiology@gmail.com
• Phone: 82-2-3010-6575

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.