Actively Recruiting

Age: 18Years - 75Years
All Genders
ID06463366

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

Led by Shengjing Hospital · Updated on 2025-02-28

100

Participants Needed

1

Research Sites

134 weeks

Total Duration

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AI-Summary

What this Trial Is About

This research aims to develop and validate advanced, non-invasive Magnetic Resonance Imaging (MRI) techniques to assess liver damage in patients with chronic liver disease. It focuses on improving the diagnosis of liver fibrosis, inflammation, and fat content without relying on liver biopsies, which are invasive and sample only a small portion of the liver. The study addresses a critical need for better tools to manage chronic hepatitis and reduce risks associated with current methods. The study uses advanced MRI methods, including 3D Magnetic Resonance Elastography (3D-MRE) and MRI Proton Density Fat Fraction (MRI-PDFF), to measure liver stiffness, inflammation, fibrosis, and fat content. Researchers will build a predictive model using functional MRI metrics such as storage modulus, loss modulus, and damping ratio. Participants will be followed every six months to monitor changes and evaluate liver health. Participants will undergo these MRI assessments at regular six-month intervals to track liver stiffness changes before and after treatment. The main measurement is how liver stiffness changes over 12 months, which may help predict treatment effectiveness. The study aims to reduce dependence on liver biopsies, allow earlier diagnosis, and provide a comprehensive evaluation of liver conditions, including cirrhosis and cancer risks, during the follow-up period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with chronic liver disease (such as viral hepatitis, alcoholic hepatitis, non-alcoholic steatohepatitis, primary biliary cirrhosis, or primary sclerosing cholangitis)
  • Between 18 and 75 years old
  • Willing to accept systematic antiviral therapy, hormone therapy, ursodesoxycholic acid, or supportive liver protection therapy
Not Eligible

You will not qualify if you...

  • Under 18 years old
  • Unable or unwilling to give informed consent
  • Have contraindications to MRI
  • Have electrical implants like pacemakers or perfusion pumps
  • Have 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
  • Have ferromagnetic objects like jewelry or metal clips in clothing
  • Pregnant
  • Pre-existing conditions that increase the risk of seizures or claustrophobia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Initial evaluation period

Participants undergo non-invasive MRI scans to assess liver inflammation, fibrosis, and fat content using advanced MRI techniques.

1 baseline visit (in-person)

Long-term Monitoring

Duration - Up to 12 months

Participants are monitored every 6 months with MRI scans to evaluate changes in liver stiffness and treatment effectiveness over time.

Visits every 6 months for up to 12 months (in-person)

Trial Site Locations

Total: 1 location

1

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China, 110004

Actively Recruiting

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Research Team

Y

Yu Shi

R

Ruobing Bai

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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