RecruitingNot ApplicableNCT06537193

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


Sponsor

Asan Medical Center

Enrollment

455 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study compares a short-version MRI scan using a special contrast agent (gadoxetic acid) against standard CT scans for monitoring liver cancer (HCC) survivors after successful treatment. The aim is to find a faster, potentially more accurate surveillance option. **You may be eligible if...** - You have been successfully treated for liver cancer (HCC) by surgery or local ablation - You have had no recurrence for more than 2 years after treatment - You have never received systemic therapy or trans-arterial chemoembolization for HCC - You are over 20 years old and in stable health **You may NOT be eligible if...** - You have another active cancer with a high recurrence risk - You have severely reduced kidney function (eGFR below 30) - You have a serious illness with a life expectancy under 3 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTAMRI

The study subjects will receive intravenous injection of gadoxetic acid (0.025 mmol/kg, Primovist; Bayer, Berlin, Germany) in the waiting room and then proceed to the examination room for MRI testing 15-20 minutes later. The MRI examination will be conducted using a 3-Tesla MRI machine, and the MRI protocol consists of T2-weighted imaging,diffusion-weighted imaging (b value of 0, 50, and 500 s/mm2), and hepatobiliary phase imaging.

DIAGNOSTIC_TESTCT

CT will be performed by obtaining dynamic phases (precontrast phase, arterial phase, portal venous phase, and delayed phase images). Subjects will receive intravenous injection of iodine contrast media. Scan coverage was from the basal lung to the iliac crest or pelvis.


Locations(1)

Asan Medical Center

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06537193


Related Trials