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

NCT ID: NCT05168982

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Fibrosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

healthy subjects

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Chen Weitian

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Chinese University of Hong Kong, Prince of Wale Hospital

Hong Kong, Shatin, Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Weitian Chen

Role: CONTACT

3505 1036

Facility Contacts

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Weitian Chen

Role: primary

3505 1036

Other Identifiers

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2021.372

Identifier Type: -

Identifier Source: org_study_id

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