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NCT07010588
NA

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

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1389

Start Date

2025-06

Completion Date

2030-06

Last Updated

2025-06-08

Healthy Volunteers

No

Interventions

DEVICE

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.

DEVICE

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.

Locations (12)

Peking University People's Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Army Medical University

Chongqing, Chongqing Municipality, 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

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, China

People's Hospital of Xishuangbanna Dai Autonomous Prefecture

Xishuangbanna Dai Autonomous Prefecture, Yunnan, China