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ClinicalTrials.gov ID

NCT07010588

Lead Sponsor

Peking University People's HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,389Estimated

Last Update Posted

Jun 8, 2025Actual

Start Date

Jun 2025Estimated

Primary Completion Date

Jun 2028Estimated

Completion Date

Jun 2030Estimated

Official Title

Comparison of ultraSound, Abbreviated MRI witH and Without HBP aS mOdalities for HCC suRveillance in patienTs With High Risk: a Multi-centers, Randomized Controlled Open-label Trial

Brief Summary

Active surveillance in high-risk hepatocellular carcinoma (HCC) populations enables early detection of tumors. The currently recommended monitoring protocol involves biannual serum alpha-fetoprotein (AFP) testing combined with liver ultrasound (US) examinations. However, conventional US demonstrates limited sensitivity in detecting early-stage HCC lesions.

MRI demonstrates high sensitivity in monitoring cirrhotic patients, but prolonged scanning time limits its routine clinical application. Several abbreviated MRI protocols have been developed for HCC detection, aiming to reduce acquisition time while improving early-stage HCC diagnostic accuracy.

The main question this clinical trial aims to answer is:

Can non-contrast abbreviated MRI (NC-AMRI) and enhanced abbreviated MRI (E-AMRI) detect more early-stage HCC lesions compared to US-based screening? Researchers will randomly divide the participants into three groups in a 1:1:1 ratio, with different surveillance strategies, focused on early HCC detection rates.

Detailed Description

Active surveillance in high-risk hepatocellular carcinoma (HCC) populations enables early detection of tumors. Current guidelines recommend biannual AFP testing with liver ultrasound (US), but US has suboptimal sensitivity for early HCC detection.

MRI, while highly sensitive for monitoring cirrhotic patients, is limited in routine use due to long scan times.. Several abbreviated MRI protocols have been developed for HCC detection, aiming to reduce acquisition time while improving early-stage HCC diagnostic accuracy.

This is a multicenter, randomized controlled, open-label clinical trial targeting individuals at high risk for HCC, with a planned enrollment of 1,389 participants.

This trial aims to evaluate the effectiveness of three surveillance strategies-US, non-contrast abbreviated MRI (NC-AMRI; T2WI/DW sequences ) and enhanced abbreviated MRI (E-AMRI; using gadoxetic acid disodium with T2WI/DWI/HBP sequences)-in the active monitoring of HCC in high-risk populations.

Researchers will randomly assign participants (1:1:1) to three surveillance arms, followed by a 24-month long-term follow-up after the initial 18-month monitoring. The study includes 18 months of active surveillance and 24 months of extended follow-up.

The surveillance protocols of three groups:

1. Control: Biannual US + AFP;
2. NC-AMRI: Alternating NC-AMRI (T2WI/DWI) and US at 6/18 months;
3. E-AMRI: Alternating E-AMRI (T2WI/DWI/HBP with gadoxetic acid) and US at 6/18 months.

All the participants will be followed up every 6 months according to the above-mentioned grouping and follow-up contents. For those participants who are suspected HCC, an enhanced abdominal CT or enhanced MRI will be performed for confirmation. If the imaging suggests HCC, the research subject will be removed from the group and enter the clinical routine diagnosis and treatment process. If there is no evidence of HCC, the subject will continue to be followed up as planned. Finally, at the end of the 18-month follow-up period, a routine enhanced abdominal CT/MRI will be carried out to confirm the presence of HCC.

The primary focus of the clinic trial is the the early-stage (BCLC 0+A stage) HCC detection rate at 18th month post-enrollment, with pairwise comparisons among the three strategies.

χ² tests will compare detection rates, sensitivity, and specificity; Kaplan-Meier analysis with log-rank tests will evaluate survival. Survival analysis will include all HCC cases diagnosed in the study.

• Hepatocellular Carcinoma (HCC)
• Magnetic Resonance Imaging (MRI)
• Randomized Controlled Trial

• non-contrast abbreviated MRI (NC-AMRI)
• enhanced abbreviated MRI (E-AMRI)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion criteria

• According to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) from department of medical administration, nation health commission of the People's Republic of China, with any one of the following high-risk factors for liver cancer: hepatitis B and/or C virus infection, excessive alcohol consumption, hepatic steatosis or metabolic dysfunction-associated liver disease, dietary exposure to aflatoxin B1, liver cirrhosis from other causes, or a family history of liver cancer, and an aMAP score (age⁃male⁃albi⁃platelets score) of 60-100 points.
• Liver disease patients with no evidence of suspected liver cancer in any imaging examination (liver US, contrast-enhanced CT, or contrast-enhanced MRI) within the past six months.
• Signed informed consent form.

Exclusion Criteria:

• History of previous liver cancer diagnosis.
• Baseline screening at enrollment diagnosed with liver cancer.
• Child-Pugh score ≥ 10 (class C).
• History of other malignant tumors.
• Pregnant or lactating women.
• Clinically diagnosed severe heart/lung disease or uncontrolled comorbidities, with investigator-judged life expectancy < 2 years.
• Glomerular filtration rate < 50 mL/min.
• Inability to undergo (enhanced) MRI due to contraindications or relative contraindications.
• Poor compliance or unsuitability for the clinical trial as judged by the investigator.

Primary Purpose

Screening

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

National Research Institute for Family Planning, ChinaOTHER_GOV

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