An interventional study of non-contrast abbreviated MRI (NC-AMRI) and enhanced abbreviated MRI (E-AMRI) in Hepatocellular Carcinoma (HCC), Magnetic Resonance Imaging (MRI) and Randomized Controlled Trial, sponsored by Peking University People's Hospital. Not yet recruiting at 12 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Screening
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.
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:
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.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 953 are open to participants now.
This study's planned enrollment of 1,389 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
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Exclusion Criteria:
After being enrolled, the participants will undergo a liver US examination and a serum AFP test every six months. 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. After the completion of 18 months surveillance, researchers will continue long-term follow-up for another 24 months.
After the participants are enrolled, a serum AFP test and a NC-AMRI examination including T2-weighted imaging (T2WI) and diffusion-weighted imaging (DWI) will be conducted at the 6th month. A liver US examination and a serum AFP test will be carried out at the 12th month. A serum AFP test and a NC-AMRI examination will be performed at the 18th month. 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. After the completion of 18 months surveillance, researchers will continue long-term follow-up for another 24 months.
Device: non-contrast abbreviated MRI (NC-AMRI)
After the participants are enrolled, a serum AFP test and a E-AMRI examination (using gadoxetic acid disodium) including T2WI, DWI and hepatobiliary phase (HBP) images will be conducted at the 6th month. A liver US examination and a AFP test will be carried out at the 12th month. A serum AFP test and a E-AMRI examination will be performed at the 18th month. 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. After the completion of 18 months surveillance, researchers will continue
Device: enhanced abbreviated MRI (E-AMRI)
Non-contrast abbreviated MRI (NC-AMRI) examination include T2-weighted imaging (T2WI) and diffusion-weighted imaging (DWI), which takes 10 minutes approximately.
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.
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.
Time frame: at 18th month
18th month mortality rate in HCC patients
Number of deaths/population of HCC patients\*100%
Time frame: at 18th month
18th month survival rate in HCC patients
Number of survivals/population of HCC patients\*100%
Time frame: at 18th month
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
Time frame: at 18th month
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Time frame: at 18th month
the incremental cost-effectiveness ratio (ICER)
ICER (NC-AMRI)=(Total costs of NC-AMRI group)-(Total Costs of control group) / (Number of early-stage HCC patients detected in NC-AMRI group)- (Number of early-stage HCC patients detected in control group) . ICER (E-AMRI)=(Total costs of E-AMRI group)-(Total Costs of control group) / (Number of early-stage HCC patients detected in E-AMRI group)- (Number of early-stage HCC patients detected in control group). Total costs should include: * Direct medical costs (Screening/diagnostic procedures e.g. MRI, blood tests) * Direct non-medical costs (Transportation) * Indirect costs A below-threshold ICER confirms the cost-effectiveness of the new intervention.
Time frame: at 18th month
Patient compliance to the study protocol
(Number of enrolled participants) - (Number of loss to follow-up cases)/(Number of enrolled participants)
Time frame: at 18th month
Patient acceptability to the study protocol
Collect data by conducting a questionnaire survey among participants
Time frame: at 18th month
early and very early-stage HCC detection at 42th month
Proportion of early and very early-stage HCC detection.
Time frame: at 42th month
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital