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

NCT07010588 · tracked via the Priya Life Science China tracker

Sponsor

Peking University People's Hospital

Phase

Not applicable

Started

2025-06

Last updated

2025-06-08

Condition(s) studied

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

Investigational drug(s) / intervention(s)

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

non-contrast abbreviated MRI (NC-AMRI): Non-contrast abbreviated MRI (NC-AMRI) examination include T2-weighted imaging (T2WI) and diffusion-weighted imaging (DWI), which takes 10 minutes approximately.

enhanced abbreviated MRI (E-AMRI): E-AMRI examination (using gadoxetic acid disodium) including T2-weighted imaging (T2WI) and diffusion-weighted imaging (DWI)and hepatobiliary phase (HBP) images, which takes 15 minutes approximately.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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 outcome measure(s)

the early-stage and very early-stage HCC detection rate — at 18th month
The primary outcome measure is the proportion of early-stage (BCLC 0+A stage) HCC diagnoses at 18th month, when a routine enhanced abdominal CT/MRI will be carried out to confirm the presence of HCC.

Trial sites (12)

Facility	City	Region
Peking University People's Hospital	Beijing	Beijing Municipality
The First Affiliated Hospital of Army Medical University	Chongqing	Chongqing Municipality
Handan Central Hospital	Handan	Hebei
Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China-Japan Union Hospital, Jilin University	Changchun	Jilin
The Second Hospital of Jilin University	Changchun	Jilin
Qilu Hospital of Shandong University	Jinan	Shandong
The Affiliated Hospital of Qingdao University	Qingdao	Shandong
The Second Affiliated Hospital of Xi'an Jiaotong University	Xi’an	Shanxi
Tianjin Second People's Hospital	Tianjin	Tianjin Municipality
People's Hospital of Xishuangbanna Dai Autonomous Prefecture	Xishuangbanna Dai Autonomous Prefecture	Yunnan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07010588 on ClinicalTrials.gov ↗ ← All trials in China