Development of Non-Invasive MRI Applications for Liver Fibrosis and Inflammation

NCT05168982 | Completed

• 1 other identifier: 2021.372
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic liver disease is a major healthcare problem in Hong Kong and worldwide. The diagnosis of liver fibrosis and inflammation in patients with chronic liver disease has important prognostic and therapeutic implications. The current gold standard to evaluate and stage the severity of liver fibrosis and inflammation is based on liver biopsies, which are invasive and impractical for screening and monitoring the disease. The existing non-invasive methods still have significant limitations to meet the challenge. Magnetic resonance effect can be used to obtain the molecular-level information on the biochemical properties of human tissues. The investigators will develop non-invasive quantitative MRI technologies to evaluate and stage liver fibrosis and inflammation. Our approaches are based on the endogenous contrast mechanism and thus do not need to inject an MRI contrast agent. Our approaches can be implemented on a regular MRI scanner and do not need any extra hardware. To enable the technology for routine clinical use, the investigators will develop fully automated post-processing techniques for the proposed MRI acquisition approaches. The investigators will perform multi-center clinical studies in Hong Kong and mainland China to validate our imaging measurements by histopathologic results from liver biopsies on patient cohorts.

Conditions

Liver Fibrosis

Keywords

MRI, liver fibrosis, liver inflammation

Outcome Measures

Primary Outcomes (1)

• To compare the measurement between subjects with different grades of liver inflammation and stages of liver fibrosis

  T-Test or one-way analysis of variance (ANOVA) will be performed for continuous variables with normally distribution, along with Kruskal-Wallis test or Mann-Whitney U test for continuous variables with skewed or unknown distribution, while χ2 or Fisher exact test will be carried out for categorical variables.

  one year

Study Arms (10)

Chronic liver disease (CLD) patients at stage A0 of liver inflammation

Chronic liver disease (CLD) patients at stage A1 of liver inflammation

Chronic liver disease (CLD) patients at stage A2 of liver inflammation

Chronic liver disease (CLD) patients at stage A3 of liver inflammation

Chronic liver disease (CLD) patients at stage F0 of liver fibrosis

Chronic liver disease (CLD) patients at stage F1 of liver fibrosis

Chronic liver disease (CLD) patients at stage F2 of liver fibrosis

Chronic liver disease (CLD) patients at stage F3 of liver fibrosis

Chronic liver disease (CLD) patients at stage F4 of liver fibrosis

healthy subjects

Eligibility Criteria

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

Study Population

Chronic liver disease (CLD) patients at different stages of liver inflammation (A0-3) and liver fibrosis (F0-4)

You may qualify if:

• Between the age of 18 and 65.
• Chronic liver disease (CLD) patients at different stages of liver inflammation (A0-3) and liver fibrosis (F0-4).
• CLD patients who have indications and are scheduled to undergo liver biopsy.

You may not qualify if:

• Patients diagnosed with HCC or other types of cancers.
• Patients who had undergone liver transplantation before enrollment.
• Any contraindications to either liver biopsy or MRI scan.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong, Prince of Wale Hospital

Hong Kong, Shatin, Hong Kong

Location

MeSH Terms

Conditions

Liver Cirrhosis; Hepatitis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 23, 2021
• Study Start: August 1, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

HK (1)