Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06463366

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location status: Recruiting

Location contact

Yu Shi, MD

CONTACT

[email protected]

+8618940259980

About this study

Patients with chronic hepatitis have increased risks of liver damage, including fibrosis and cirrhosis, which may eventually lead to hepatocellular carcinoma and end-stage liver disease requiring liver transplantation. These diseases are/will be the source of enormous health care costs and morbidity/mortality in the China.

Most hepatologists still rely on liver biopsy findings in patients newly diagnosed with chronic hepatitis, which enables the assessment of liver damage (fibrosis and inflammation). Liver biopsy has limitations, including cost, invasiveness, poor patient acceptance, limited sampling, inter-observer variability and is difficult to repeat.

Non invasive tests to capture the extent of liver damage at a larger scale are urgently needed. These will gain more acceptance among patients and hepatologists.

In this proposal, the investigators would like to test and validate non invasive MRI methods based on advanced MR elastography and MRI-PDFF techniques for the detection of fibrosis, cirrhosis and liver fat content in patients with chronic hepatitis. In order to improve the diagnostic performance of MRI, the investigators would like to build and validate a predictive model based on advanced functional MRI metrics (storage modulus, loss modulus and damping ratio [DR]) by follow up every 6 month. If validated, this novel non invasive algorithm will not only decreases the number of liver biopsies, but also enable earlier diagnosis of liver fibrosis when antiviral treatment is more effective, and enable a comprehensive evaluation of the liver (to assess for cirrhosis, portal hypertension and hepatocellular cancer).

This study is aimed to evaluate whether the change of liver stiffness assessed by MRE can predict treatment effectiveness in chronic liver disease treatment by follow up every 6 month.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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)

Primary outcomes

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

    Time frame: 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Jun 17, 2024
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.