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Study on the Quantitative Assessment of the Risk of Hepatocellular Carcinoma in Patients With Chronic Liver Disease Using Multi-parameter Magnetic Resonance Imaging

NCT ID: NCT06060769

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2029-01-31

Brief Summary

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Quantitative MRI scanning parameters such as T1 mapping, T2 mapping, T1ρ, and elastography are used, combined with clinical and laboratory indicators, to predict the risk of liver cancer in patients with cirrhosis.

Detailed Description

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Retrospectively and prospectively collect T1 mapping, T2 mapping, T2\* mapping, T1ρ, elastography and other multi-parameter MRI sequence images and clinical and laboratory examination data from patients with liver cirrhosis, and conduct 5-year clinical follow-up and monitoring of all enrolled patients. Whether patients develop hepatocellular carcinoma, patients are divided into liver cancer occurrence group and non-hepatocellular carcinoma group according to clinical follow-up results. Cox proportional hazard analysis is used to compare the differences in clinical characteristics, laboratory tests, imaging characteristics, quantitative MRI parameters and other variables between the two groups of patients. , and calculate the hazard ratio for each variable; assign a score to each covariate based on the proportion of the hazard ratio in the multivariable model, and develop a nomogram to predict HCC risk by the total score.

Conditions

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Cirrhosis； Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HCC group

Patients who develop HCC during follow-up

No interventions assigned to this group

non-HCC group

Patients who did not develop HCC during follow-up

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 1\. Aged over 18 years old; 2. Liver function Child-Pugh classification A or B; 3. Patients with chronic liver disease who meet the diagnostic criteria for high-risk groups of liver cancer in the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)"; 4. Equipped with Gd-EOB-DTPA enhanced MRI scan images, including T1 mapping, T2 mapping, T2\* mapping, T1ρ and other sequences; 5. With 5-year follow-up data.

Exclusion Criteria

* 1\. Patients who are unable to undergo MRI scanning due to claustrophobia, abnormal renal function, etc.; 2. Patients who have undergone liver surgery in the past; 3. Patients with major diseases such as heart failure and tumors.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yaqin Zhang, MD, Ph.D

Role: STUDY_CHAIR

Fifth Affiliated Hospital, Sun Yat-Sen University

Locations

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Yaqin, Zhang

Zhuhai, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yaqin Zhang, MD, Ph.D

Role: CONTACT

Phone: 13719282895

Email: [email protected]

Facility Contacts

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Yaqin Zhang

Role: primary

Other Identifiers

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ZDWY.FSK.028

Identifier Type: -

Identifier Source: org_study_id