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.
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.
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.
Parallel
non-contrast abbreviated MRI (NC-AMRI)
DeviceNon-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)
DeviceE-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.
the early-stage and very early-stage HCC detection rate
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.
18th month mortality rate in HCC patients
Number of deaths/population of HCC patients\*100%
18th month survival rate in HCC patients
Number of survivals/population of HCC patients\*100%
18th median survival time in HCC patients
Survival analysis will be performed using the Kaplan-Meier method for patients who developed HCC during the study period
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
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Peking University People's Hospital
Lead sponsor
National Research Institute for Family Planning
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
