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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Liver Fibrosis

Study type: Observational

Funder types: Other

Identifiers

NCT05168982

2021.372

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

200 participants in 10 patient groups

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