Comparison of ultraSound, Abbreviated MRI witH and Without HBP aS mOdalities for HCC suRveillance in patienTs With High Risk

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · May 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying different methods to detect early-stage liver cancer, specifically hepatocellular carcinoma (HCC), in patients who are at high risk for developing this condition. The researchers want to find out if two types of abbreviated MRI scans—one without contrast (NC-AMRI) and one with contrast (E-AMRI)—can find more early-stage HCC lesions than the standard ultrasound (US) method currently used. Participants will be randomly assigned to one of three groups, each using a different screening strategy to see which one is most effective at spotting early signs of liver cancer.

To be eligible for the study, participants should be between the ages of 65 and 74 and have certain risk factors for liver cancer, such as chronic hepatitis B or C infections, heavy alcohol use, or liver cirrhosis. It’s important that potential participants have not been diagnosed with liver cancer in the past six months and can provide informed consent to join the trial. Those who meet the criteria will undergo different imaging tests over the course of the study, helping researchers learn more about the best ways to monitor for liver cancer in high-risk patients.

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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.