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

NCT06537193 | Recruiting

• 1 other identifier: 2023-1630
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Keywords

Abbreviated MRI; Dynamic CT

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• DR of patients with early stage HCC

  6 months after the completion of the 2 surveillance rounds

• FRR of patients with early stage HCC

  6 months after the completion of the 2 surveillance rounds

• DR of patients with very early stage HCC

  6 months after the completion of the 2 surveillance rounds

• FRR of patients with very early stage HCC

  6 months after the completion of the 2 surveillance rounds

Study Arms (1)

AMRI and CT

EXPERIMENTAL

Procedure: AMRI examination 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 will consist of T2-weighted imaging, diffusion-weighted imaging (b value of 0, 50, and 500 s/mm2), and hepatobiliary phase imaging. Procedure: dynamic 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 will be from the basal lung to the iliac crest or pelvis.

Diagnostic Test: AMRI; Diagnostic Test: CT

Interventions

AMRI DIAGNOSTIC_TEST

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.

AMRI and CT

CT DIAGNOSTIC_TEST

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.

AMRI and CT

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu , 88, Olympic-ro 43-gil, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• So Yeon Kim, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

So Yeon Kim, MD, PhD

CONTACT

82-2-3010-6575; sykim.radiology@gmail.com

Hyo Jung Park, MD, PhD

CONTACT

82-2-3010-0627; happyeahj@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The sample size may be adjusted based on a blinded interim assessment of the pooled event rate.

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 5, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)