Liver FibrosisNCT05168982
Development of Non-Invasive MRI Applications for Liver Fibrosis and Inflammation
An observational study of Liver Fibrosis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Fibrosis
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chronic liver disease (CLD) patients at different stages of liver inflammation (A0-3) and liver fibrosis (F0-4)
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Hong Kong1 site
The Chinese University of Hong Kong, Prince of Wale Hospital
Hong Kong, Shatin
About this study
Official title: 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.
- Conditions
- Liver Fibrosis
- Keywords
- MRI, liver fibrosis, liver inflammation
- Medical subject headings
- Liver Cirrhosis, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic liver disease (CLD) patients at stage A0 of liver inflammation | Not described | |
| Chronic liver disease (CLD) patients at stage A1 of liver inflammation | Not described | |
| Chronic liver disease (CLD) patients at stage A2 of liver inflammation | Not described | |
| Chronic liver disease (CLD) patients at stage A3 of liver inflammation | Not described | |
| Chronic liver disease (CLD) patients at stage F0 of liver fibrosis | Not described | |
| Chronic liver disease (CLD) patients at stage F1 of liver fibrosis | Not described | |
| Chronic liver disease (CLD) patients at stage F2 of liver fibrosis | Not described | |
| Chronic liver disease (CLD) patients at stage F3 of liver fibrosis | Not described | |
| Chronic liver disease (CLD) patients at stage F4 of liver fibrosis | Not described | |
| healthy subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start1 Aug 2021
- Primary completion30 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Weitian, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168982
- Sponsor's protocol ID
- 2021.372
- Status last verified
- Mar 2026
- First submitted
- 10 Dec 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Fully Automated Non-Invasive MRI Applications for Diagnosis and Staging of Liver Fibrosis and Inflammation
- ClinicalTrials.gov ID
- NCT05168982
- Acronym / sponsor ID
- 2021.372
- Conditions
- Liver Fibrosis
- Keywords
- MRI, liver fibrosis, liver inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic liver disease (CLD) patients at different stages of liver inflammation (A0-3) and liver fibrosis (F0-4)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibrosis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the measurement between subjects with different grades of liver inflammation and stages of liver fibrosis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.