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

Liver Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05168982
• Other study ID #: 2021.372
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: Weitian Chen
• Phone: 3505 1036
• Email: wtchen[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Inflammation
• Liver Cirrhosis
• Liver Fibrosis

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong, Prince of Wale Hospital	Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ?2 or Fisher exact test will be carried out for categorical variables.	one year