Non-alcoholic Fatty Liver Disease (NAFLD)NCT05384652
Simultaneous Quantification of Liver Fat Content, Fatty Acid Composition, and Fibrosis Using Spin-lock MRI for Steatohepatitis Assessment
An observational study of Non-alcoholic Fatty Liver Disease (NAFLD) and Non-alcoholic Steatohepatitis (NASH), run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Non-alcoholic fatty liver disease is a major health problem worldwide. It includes simple steatosis and NASH which has inflammation in the liver, with or without fibrosis. Fat content, fibrosis, and inflammation are three important components to evaluate NASH. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease (NAFLD), Non-alcoholic Steatohepatitis (NASH)
- How many people
- 140 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2024to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: subjects with NASH or with simple steatosis
Who may be able to join
- Between 18 and 65 years of age.
- Non-alcoholic fatty liver disease (NAFLD) patients at stage of either Non-alcoholic steatohepatitis (NASH) or simple steatosis
- NAFLD patients scheduled to undergo liver biopsy.
- No abnormal lesions detected at baseline MRI exam for healthy volunteers.
Who cannot join
- Evidence of hepatocarcinoma (HCC) or any other types of neoplasm.
- Patients who had undergone liver transplantation.
- 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: Simultaneous Quantification of Liver Fat Content, Fatty Acid Composition, and Fibrosis Using Non-invasive Breath-hold Quantitative Spin-lock MRI for Assessment of Non-Alcoholic Steatohepatitis
Non-alcoholic fatty liver disease is a major health problem worldwide. It includes simple steatosis and NASH which has inflammation in the liver, with or without fibrosis. Fat content, fibrosis, and inflammation are three important components to evaluate NASH. Liver biopsy is the current gold standard for the diagnosis of NASH. Liver biopsy; however, is invasive. The existing non-invasive methods still have significant limitations to assess NASH. It was reported that quantification of fatty acid composition is feasible for evaluation of metabolic disorders and inflammatory conditions. However, this measurement cannot be used to evaluate fibrosis. Liver fibrosis is characterized by excessive deposition of collagen-rich connective tissues in the liver, which can be quantified by macromolecular proton fraction (MPF), an MRI parameter reflecting the macromolecular level in tissues. Although it has the potential to directly quantify fibrotic tissue, the effect of inflammation on MPF measurement was not well studied. In summary, NASH assessment using non-invasive imaging methods remains challenging. Based on our previous work of MPF imaging with spin-lock (MPF-SL) and chemical-shift encoding-based water-fat imaging in spin-lock MRI, the investigators will develop a fast acquisition technology to collect data for simultaneous quantification of liver fat content, fatty acid composition, and fibrosis within a single breath-hold less than 14 seconds. Our method does not require extra hardware and does not need to inject a contrast agent. The investigators will evaluate the repeatability and reproducibility of the proposed method on volunteers. To evaluate its clinical value, the investigators will recruit 120 subjects (60 with simple steatosis and 60 with NASH) in this study. The investigators will use histology analysis as the gold standard and evaluate the diagnostic value of our proposed method for detecting NASH. This project will provide a non-invasive diagnostic technology for the assessment of NASH. The proposed MRI technology also has the potential to be applied for other clinical purposes.
- Keywords
- chronic liver diseases, liver fibrosis, fatty acid, spin-lock MRI, non-invasive imaging
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
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 |
|---|---|---|
| subjects with NASH | Not described | |
| subjects with simple steatosis | Not described | |
| healthy subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To simultaneously quantify macromolecular proton fraction, proton density fat fraction, and fatty acid composition in liver tissues
The MRI technology developed can serve as a non-invasive, fast, and robust imaging tool to simultaneously quantify macromolecular proton fraction, proton density fat fraction, and fatty acid composition in liver tissues.
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 posted20 May 2022
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver Disease (NAFLD)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
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
- NCT05384652
- Sponsor's protocol ID
- 2022.021
- Status last verified
- Mar 2026
- First submitted
- 17 May 2022
- 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
- Simultaneous Quantification of Liver Fat Content, Fatty Acid Composition, and Fibrosis Using Non-invasive Breath-hold Quantitative Spin-lock MRI for Assessment of Non-Alcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT05384652
- Acronym / sponsor ID
- 2022.021
- Keywords
- chronic liver diseases, liver fibrosis, fatty acid, spin-lock MRI, non-invasive imaging
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 May 2022 (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.
Non-alcoholic fatty liver disease is a major health problem worldwide. It includes simple steatosis and NASH which has inflammation in the liver, with or without fibrosis. Fat content, fibrosis, and inflammation are three important components to evaluate NASH. Liver biopsy is the current gold standard for the diagnosis of NASH. Liver biopsy; however, is invasive. The existing non-invasive methods still have significant limitations to assess NASH. It was reported that quantification of fatty acid composition is feasible for evaluation of metabolic disorders and inflammatory conditions. However, this measurement cannot be used to evaluate fibrosis. Liver fibrosis is characterized by excessive deposition of collagen-rich connective tissues in the liver, which can be quantified by macromolecular proton fraction (MPF), an MRI parameter reflecting the macromolecular level in tissues. Although it has the potential to directly quantify fibrotic tissue, the effect of inflammation on MPF measurement was not well studied. In summary, NASH assessment using non-invasive imaging methods remains challenging. Based on our previous work of MPF imaging with spin-lock (MPF-SL) and chemical-shift encoding-based water-fat imaging in spin-lock MRI, the investigators will develop a fast acquisition technology to collect data for simultaneous quantification of liver fat content, fatty acid composition, and fibrosis within a single breath-hold less than 14 seconds. Our method does not require extra hardware and does not need to inject a contrast agent. The investigators will evaluate the repeatability and reproducibility of the proposed method on volunteers. To evaluate its clinical value, the investigators will recruit 120 subjects (60 with simple steatosis and 60 with NASH) in this study. The investigators will use histology analysis as the gold standard and evaluate the diagnostic value of our proposed method for detecting NASH. This project will provide a non-invasive diagnostic technology for the assessment of NASH. The proposed MRI technology also has the potential to be applied for other clinical purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| subjects with NASH | – | – |
| subjects with simple steatosis | – | – |
| healthy subjects | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- subjects with NASH or with simple steatosis
Key inclusion criteria (4 listed)
- Between 18 and 65 years of age.
- Non-alcoholic fatty liver disease (NAFLD) patients at stage of either Non-alcoholic steatohepatitis (NASH) or simple steatosis
- NAFLD patients scheduled to undergo liver biopsy.
- No abnormal lesions detected at baseline MRI exam for healthy volunteers.
Key exclusion criteria (3 listed)
- Evidence of hepatocarcinoma (HCC) or any other types of neoplasm.
- Patients who had undergone liver transplantation.
- 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 simultaneously quantify macromolecular proton fraction, proton density fat fraction, and fatty acid composition in liver tissues
Time frame: one year
The MRI technology developed can serve as a non-invasive, fast, and robust imaging tool to simultaneously quantify macromolecular proton fraction, proton density fat fraction, and fatty acid composition in liver tissues.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
Related trials for Non-alcoholic Fatty Liver Disease (NAFLD)
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Recruiting
iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) +Optimized Lifestyle Intervention (OLI) vs Sham + OLI for Weight Loss
Overweight and/or Obesity, Metabolic Syndrome
Active, not recruitingPhase 1/2
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Overweight and Obesity
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
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 Non-alcoholic Fatty Liver Disease (NAFLD) and Non-alcoholic Steatohepatitis (NASH), 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 4 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: under way, not looking for participants, 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?
This study is still under way. Results are not available in the source record yet.
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 simultaneously quantify macromolecular proton fraction, proton density fat fraction, and fatty acid composition in liver tissues (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.