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

Development of Fully Automated Non-Invasive MRI Applications for Diagnosis and Staging of Liver Fibrosis and Inflammation

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Fibrosis

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Weitian Chen; Phone Number: 3505 1036; Email: wtchen@cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin
    • Hong Kong, Shatin, Hong Kong
      • Recruiting
      • The Chinese University of Hong Kong, Prince of Wale Hospital
      • Contact: Weitian Chen; Phone Number: 3505 1036; Email: wtchen@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

10

Cohorts and Interventions

Group / Cohort
healthy subjects
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: MRI, liver fibrosis, liver inflammation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Inflammation; Liver Cirrhosis
• Other Study ID Numbers: 2021.372

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No