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

A total of 455 subjects will be evaluated by two rounds of tests with both abbreviated MRI (AMRI) and dynamic CT to detect the occurrence of secondary HCC. These two imaging tests are planned to be performed twice, with a basic interval of 16 weeks between tests. However, considering the clinical practice of varying the imaging intervals based on the patient's risk level, the actual interval between tests can range from 4 to 8 months. If a suspicious lesion indicative of HCC is detected during the study, a recall examination using complete MRI will be performed within 3 months. If the recall examination does not confirm the diagnosis, a contrast-enhanced ultrasound or biopsy will be conducted. The diagnosis of HCC will be made based on international guidelines, with a histological confirmation or classification as Liver Imaging-Reporting and Data System (LI-RADS) category 5. After the completion of the two evaluation rounds, at least 6 months of clinical follow-up data will be collected to record the occurrence of interval cancer. If HCC is confirmed during the study, the participant will be excluded from further study participation, and the treatment will proceed according to current clinical processes. If no lesions are detected during the two surveillance rounds, follow-up for up to 6 months after the second test will be conducted according to current clinical processes. If HCC is diagnosed, which is the primary outcome of the study, the study will be considered complete, and this will not be treated as an adverse event of the study. If a patient chooses not to continue participating in the study during the repeated application of the protocol, the study for that patient will conclude, even if the two rounds of testing are not completed.

Inclusion criteria

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

Exclusion criteria

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