Clinical trial NCT07010588: Comparison of ultraSound, Abbreviated MRI witH and Without HBP aS mOdalities for HCC suRveillance in patienTs With High Risk
Official title: Comparison of ultraSound, Abbreviated MRI witH and Without HBP aS mOdalities for HCC suRveillance in patienTs With High Risk: a Multi-centers, Randomized Controlled Open-label Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma (HCC)
Magnetic Resonance Imaging (MRI)
Randomized Controlled Trial
Keywords: Hepatocellular carcinoma
magnetic resonance imaging
surveillance
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: National Research Institute for Family Planning
First posted: 2025-06-08
Enrollment: 1389
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: the early-stage and very early-stage HCC detection rate
timeFrame: at 18th month
Secondary outcomes:
measure: 18th month mortality rate in HCC patients
timeFrame: at 18th month
measure: 18th month survival rate in HCC patients
timeFrame: at 18th month
measure: 18th median survival time in HCC patients
timeFrame: at 18th month
measure: Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
timeFrame: at 18th month
measure: the incremental cost-effectiveness ratio (ICER)
timeFrame: at 18th month
measure: Patient compliance to the study protocol
timeFrame: at 18th month
measure: Patient acceptability to the study protocol
timeFrame: at 18th month
measure: early and very early-stage HCC detection at 42th month
timeFrame: at 42th month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Army Medical University
state: Chongqing
city: Handan
country: China
facility: Handan Central Hospital
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changchun
country: China
facility: China-Japan Union Hospital, Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Second People's Hospital
state: Tianjin
city: Xishuangbanna
country: China
facility: People's Hospital of Xishuangbanna Dai Autonomous Prefecture
state: Yunnan
Study officials:
affiliation: Peking University People's Hospital
name: Yi Wang, Professor
role: STUDY_CHAIR
References:
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citation: Wong LL, Reyes RJ, Kwee SA, Hernandez BY, Kalathil SC, Tsai NC. Pitfalls in surveillance for hepatocellular carcinoma: How successful is it in the real world? Clin Mol Hepatol. 2017 Sep;23(3):239-248. doi: 10.3350/cmh.2017.0008. Epub 2017 Jul 14.