To Explore the Value of New MR Technology in Non-invasive Quantitative Assessment of Systemic Metabolism, Disease Status and Prognosis in Patients With Metabolic-Associated Fatty Liver Disease

NCT07149571 | Recruiting

• 1 other identifier: TJ-IRB202411109
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the value of new MR technology in assessing the systemic metabolism, disease status, and prognostic risk of metabolism-related fatty liver disease. By obtaining clinical, imaging, laboratory examination and pathological data of metabolism-related fatty liver disease, image processing software is used to analyze the images, explore the relationship between imaging parameters, body composition and metabolic diseases and metabolism-related fatty liver disease, and achieve non-invasive diagnosis, efficacy evaluation, and prognosis prediction of metabolism-related fatty liver disease. Thereby guiding clinical treatment and improving the prognosis and quality of life of patients with metabolism-related fatty liver disease

Conditions

Nonalcoholic Fatty Liver Disease; Metabolic-associated Fatty Liver Disease

Keywords

MRI, metabolism-related fatty liver disease

Outcome Measures

Primary Outcomes (1)

• Sensitivity (sensitivity) and specificity (specificity) of MR sequence measurement results vs. liver biopsy (gold standard) translated into English

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Secondary Outcomes (1)

• Time from baseline MR scan to development of liver cirrhosis, liver decompensation event, liver cancer, death

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Study Arms (1)

Metabolic-Associated Fatty Liver Disease patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinically suspected or diagnosed metabolically related fatty liver disease patients

You may qualify if:

• Patients with MR examination are clinically suspected or diagnosed with metabolism-related fatty liver disease;
• Age/gender: unlimited;
• Patients who voluntarily participate in clinical trials and sign written subject informed consent

You may not qualify if:

• Clinical suspicion or diagnosis of metabolism-related fatty liver disease and having been prescribed an MR examination;
• Voluntarily participation in the study and provision of written informed consent.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji hospital

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Zhen Li

CONTACT

02783663543; zhenli@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 2, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)