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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07010588
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-29
• Last Update Submitted: 2025-05-29
• Study Start: 2025-06
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-08
• Primary Completion: 2028-06
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1389

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
18th median survival time in HCC patients	at 18th month	Survival analysis will be performed using the Kaplan-Meier method for patients who developed HCC during the study period
18th month mortality rate in HCC patients	at 18th month	Number of deaths/population of HCC patients\*100%
18th month survival rate in HCC patients	at 18th month	Number of survivals/population of HCC patients\*100%
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).	at 18th month	Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
the incremental cost-effectiveness ratio (ICER)	at 18th month	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.
Patient acceptability to the study protocol	at 18th month	Collect data by conducting a questionnaire survey among participants
Patient compliance to the study protocol	at 18th month	(Number of enrolled participants) - (Number of loss to follow-up cases)/(Number of enrolled participants)
early and very early-stage HCC detection at 42th month	at 42th month	Proportion of early and very early-stage HCC detection.

Trial Locations

Locations (12)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Army Medical University; 🇨🇳 Chongqing, Chongqing, China

Handan Central Hospital; 🇨🇳 Handan, Hebei, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

China-Japan Union Hospital, Jilin University; 🇨🇳 Changchun, Jilin, China

The Second Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China

The Second Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shanxi, China

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