Multi-parametric Magnetic Resonance Imaging for the Precise Diagnosis and Quantitative Study of Liver Steatosis, Inflammation, and Fibrosis in Chronic Liver Disease.

NCT06463366 | Recruiting

• 1 other identifier: ShengjingH-CHD Bai
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To construct a novel, non-invasive, accurate, and convenient method to achieve the degree of liver damage is an important general problem in the management of patients with chronic liver disease. The investigators would like to develop non invasive advanced Magnetic Resonance Imaging (MRI) techniques (MR elastography, MRI-PDFF) to assess the degree of liver damage in patients with chronic liver disease. These techniques could reach high diagnostic performance for detection of liver fibrosis, inflammation and liver fat content; and could decrease the number of liver biopsies, which have risks and sample only a small portion of the liver.

Conditions

Liver Stiffness

Outcome Measures

Primary Outcomes (1)

• the changes of liver stiffness assessed by 3D-MRE before and after treatment.

  Liver stiffness regression is defined as the change of 3D MRE shear stiffness larger than 19%

  12 months

Interventions

3D-MRE,MRI-PDFF DEVICE

3D-MRE(storage modulus, ., loss modulus and damping ratio \[DR\] for liver inflammation and fibrosis) MRI-PDFF(liver fat content)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Treatment-naive patients had already been diagnosed with chronic hepatic disease before enrollment.Patients with liver disease were enrolled in this study to assess the changes in 3D-MRE and MRI-PDFF parameters before and after antiviral therapy or hormone or ursodesoxycholic acid or supportive liver protection therapy.

You may qualify if:

• Chronic liver disease (including viral hepatitis, alcoholic hepatitis, non alcoholic steatohepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, etc..)
• Age range of 18 to 75 years old
• Accept systematic antiviral therapy or hormone or ursodesoxycholic acid or supportive liver protection therapy

You may not qualify if:

• Age less than 18 years
• Unable or unwilling to give informed consent
• Contra-indications to MRI
• Electrical implants such as cardiac pacemakers or perfusion pumps
• Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
• Ferromagnetic objects such as jewelry or metal clips in clothing
• Pregnant subjects
• Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Central Study Contacts

Yu Shi

CONTACT

+86 189 4025 9980; 18940259980@163.com

Ruobing Bai

CONTACT

+86 189 4025 8589; 18940258589@163.com

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: April 16, 2024
• First Posted: June 17, 2024
• Study Start: June 14, 2022
• Primary Completion: February 1, 2023
• Study Completion: September 1, 2025
• Last Updated: February 28, 2025

Record last verified: 2024-12

Locations

CN (1)