Abbreviated MRI Using Gadoxetic Acid Versus CT for Surveillance of Recurrent HCC After Curative Treatment
NCT Number: NCT06537193
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hepatocellular Carcinoma
Interventions: DIAGNOSTIC_TEST: AMRI|DIAGNOSTIC_TEST: CT
Sponsor: Asan Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 455
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-09-23
Completion Date: 2028-12-31
Locations: Asan Medical Center, Seoul, Songpa-gu , 88, Olympic-ro 43-gil, 05505, Korea, Republic of

Summary:
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.

Primary Outcome Measures: Detection rate (DR) of patients with HCC, DR = True positive / True positive + False positive + True negative + False negative, 6 months after the completion of the 2 surveillance rounds|False referral rate (FRR) of patients with HCC, FRR = False positive / True positive + False positive + True negative + False negative, 6 months after the completion of the 2 surveillance rounds
Secondary Outcome Measures: DR of patients with early stage HCC, DR = True positive / True positive + False positive + True negative + False negative, 6 months after the completion of the 2 surveillance rounds|FRR of patients with early stage HCC, FRR = False positive / True positive + False positive + True negative + False negative, 6 months after the completion of the 2 surveillance rounds|DR of patients with very early stage HCC, DR = True positive / True positive + False positive + True negative + False negative, 6 months after the completion of the 2 surveillance rounds|FRR of patients with very early stage HCC, FRR = False positive / True positive + False positive + True negative + False negative, 6 months after the completion of the 2 surveillance rounds