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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorAsan Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • AMRI
  • CT

Treatment groups

455 Participants
are divided into 1 treatment group

Sponsors and collaborators