RECRUITINGINTERVENTIONAL

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DIAGNOSTIC_TEST

AMRI

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_TEST

CT

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