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OpenTrials
Completed

NCT Number: NCT05168982

Development of Non-Invasive MRI Applications for 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Chinese University of Hong Kong, Prince of Wale Hospital

Hong Kong, Shatin

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

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

    Time frame: one year

    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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 23, 2021
Registry last updated
Mar 19, 2026

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.

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