Nonalcoholic Fatty Liver DiseaseNCT07149571
To Explore the Value of New MR Technology in Non-invasive Quantitative Assessment of Systemic Metabolism, Disease Status and Prognosis in Patients With Metabolic-Associated Fatty Liver Disease
An observational study of Nonalcoholic Fatty Liver Disease and Metabolic-associated Fatty Liver Disease, run by Tongji Hospital at 1 site in China.
Trial summary
The purpose of this study is to explore the value of new MR technology in assessing the systemic metabolism, disease status, and prognostic risk of metabolism-related fatty liver disease. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease, Metabolic-associated Fatty Liver Disease
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Dec 2032
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Clinically suspected or diagnosed metabolically related fatty liver disease patients
Who may be able to join
- Patients with MR examination are clinically suspected or diagnosed with metabolism-related fatty liver disease;
- Age/gender: unlimited;
- Patients who voluntarily participate in clinical trials and sign written subject informed consent
Who cannot join
- Clinical suspicion or diagnosis of metabolism-related fatty liver disease and having been prescribed an MR examination;
- Voluntarily participation in the study and provision of written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji hospital
Wuhan, Hubei
Zhen Li, +862783663543, zhenli@hust.edu.cn
About this study
The purpose of this study is to explore the value of new MR technology in assessing the systemic metabolism, disease status, and prognostic risk of metabolism-related fatty liver disease. By obtaining clinical, imaging, laboratory examination and pathological data of metabolism-related fatty liver disease, image processing software is used to analyze the images, explore the relationship between imaging parameters, body composition and metabolic diseases and metabolism-related fatty liver disease, and achieve non-invasive diagnosis, efficacy evaluation, and prognosis prediction of metabolism-related fatty liver disease. Thereby guiding clinical treatment and improving the prognosis and quality of life of patients with metabolism-related fatty liver disease
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) is a chronic progressive liver disease caused by overnutrition and insulin resistance (IR) in genetically susceptible individuals. The disease spectrum includes non-alcoholic fatty liver (NAFL), non-alcoholic steatohepatitis (NASH) and its associated fibrosis and liver cirrhosis [1-2]. With the prevalence of obesity and type 2 diabetes mellitus (T2DM), the global prevalence and incidence of NAFLD continue to increase, especially in my country [3-5]. NAFLD is the most common chronic liver disease in the world and the main cause of elevated serum transaminases in healthy people undergoing physical check-ups. It has now replaced viral hepatitis as the largest chronic liver disease in my country [4-5,10]. In addition, NAFLD, metabolic syndrome (MetS) and T2DM are mutually causal, and together promote the development of malignant tumors such as arteriosclerosis cardiovascular disease (CVD), chronic kidney disease (CKD), liver decompensation, and hepatocellular carcinoma (HCC)[1- 2, 6 -7]. To this end, NAFLD has become an increasingly serious public health problem in my country [4,8]. In 2020, the International Fatty Liver Expert Group recommended that NAFLD be renamed metabolic dysfunction-associated fatty liver disease (MAFLD). The Hepatology Branch of the Chinese Medical Association actively stated its position [8], emphasizing that the diagnosis and treatment of NAFLD needs to follow the actual situation in my country. After extensive discussion, it was recommended that the English terms MAFLD and MASLD be translated into "metabolically related fatty liver disease. Diagnosis of MAFLD requires the exclusion of excessive drinking (weekly ethanol intake ≥210g in men and ≥140g in women) and other causes that can lead to fatty liver, and the patient has at least 1 MetS component [1-2]. Patients with suspected MAFLD need to routinely test blood biochemical analysis indicators and evaluate liver steatosis and fibrosis. At the same time, MetS components should be systematically screened and CVD risk should be assessed. Common malignancies and esophageal varices should be screened according to relevant guidelines. Liver biopsy histology is still the gold standard for evaluating liver steatosis and fibrosis [1-2].
MetS, T2DM and NAFLD interact with each other to promote the pathogenesis of metabolization-related diseases in multiple systems and organs across the body. The prognosis of patients with NAFLD is mainly related to CVD and non-hepatic malignancies. Liver related events (liver decompensation, HCC, liver transplantation, or liver-related death) are significantly increased when combined with progressive fibrosis [2,6-7]. MetS is independently associated with increased all-cause mortality and liver and CVD related mortality in patients with NAFLD. T2DM has a greater impact on the prognosis of patients with NAFLD than obesity. Obesity is also a factor that needs to be prevented and managed urgently. Adipose tissue in different parts of the human body is different in anatomy, cells, molecules, etc., so it is of great significance to more accurately measure and divide adipose tissue and muscles in the human body and explore their correlation with renal dysfunction. At present, the research technology using CT or MR images to automatically segment various body components of patients is constantly improving. Therefore, it is also of great significance to accurately assess the metabolic status of patients with metabolism-related fatty liver disease and explore the mechanisms related to metabolism and liver function, which will help doctors make clinical diagnosis and subsequent assisted designation of treatment plans.
Magnetic resonance imaging (MRI) is widely used in medical imaging. Because of its non-invasive nature, high soft tissue resolution and multi-parameter analysis capabilities, it has become a key tool for the assessment and diagnosis of a variety of diseases. MRI can provide high-resolution images of tissue structures and can assess the functional status and metabolic activity of tissue through different imaging sequences, such as T1 and T2 weighted imaging, diffusion weighted imaging (DWI), and magnetization transfer imaging (MT) imaging. These characteristics and the constantly updated new imaging sequences allow MRI to demonstrate great potential in assessing liver disease, especially in non-invasively assessing tissue structure and functional status. MRI can not only display the anatomical structure of an organ in detail, but also monitor the fat fraction and functional status of an organ through multi-parameter imaging technology. For example, magnetic resonance imaging-derived protondensity fat fraction (MRI-PDFF) objectively evaluates the entire liver fat content and has been used in clinical trials to assess changes in liver fat content. MRI-PDFF≥5% and 10% indicate significant and moderate-severe liver steatosis, respectively.
With the advancement of precision medicine and the rapid development of artificial intelligence in recent years, the combination of imagingomics and machine learning technologies has further enhanced the potential of MRI applications. Imagingomics is capable of automating and improving accurate diagnosis through high-throughput image feature extraction combined with machine learning models. These technologies show great potential especially in the staging and grading of metabolism-related fatty liver disease and prognostic assessment, where the accuracy and reliability of the assessment can be significantly improved through the construction of accurate models. Looking forward, the clinical application of CT and MRI technologies in the noninvasive evaluation of patients with metabolic-related fatty liver disease is promising. Their potential to improve patients' quality of life and liver health is enormous. However, current challenges remain, including the diffusion and standardization of the techniques, the accumulation and analysis of data, and the need for multicenter clinical studies. Nonetheless, through continued technological development and research, the use of MRI in the evaluation of patients with metabolism-related fatty liver disease will become more widespread and intensive.
- Keywords
- MRI, metabolism-related fatty liver disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
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 |
|---|---|---|
| Metabolic-Associated Fatty Liver Disease patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity (sensitivity) and specificity (specificity) of MR sequence measurement results vs. liver biopsy (gold standard) translated into English
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Secondary outcomes (1)
Time from baseline MR scan to development of liver cirrhosis, liver decompensation event, liver cancer, death
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Apr 2025
- Primary completion1 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Li, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149571
- Sponsor's protocol ID
- TJ-IRB202411109
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: protect patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Value of New MR Technology in Non-invasive Quantitative Assessment of Systemic Metabolism, Disease Status and Prognosis in Patients With Metabolic-Associated Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT07149571
- Acronym / sponsor ID
- TJ-IRB202411109
- Keywords
- MRI, metabolism-related fatty liver disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 2 Sep 2025 (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.
The purpose of this study is to explore the value of new MR technology in assessing the systemic metabolism, disease status, and prognostic risk of metabolism-related fatty liver disease. By obtaining clinical, imaging, laboratory examination and pathological data of metabolism-related fatty liver disease, image processing software is used to analyze the images, explore the relationship between imaging parameters, body composition and metabolic diseases and metabolism-related fatty liver disease, and achieve non-invasive diagnosis, efficacy evaluation, and prognosis prediction of metabolism-related fatty liver disease. Thereby guiding clinical treatment and improving the prognosis and quality of life of patients with metabolism-related fatty liver disease
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is a chronic progressive liver disease caused by overnutrition and insulin resistance (IR) in genetically susceptible individuals. The disease spectrum includes non-alcoholic fatty liver (NAFL), non-alcoholic steatohepatitis (NASH) and its associated fibrosis and liver cirrhosis [1-2]. With the prevalence of obesity and type 2 diabetes mellitus (T2DM), the global prevalence and incidence of NAFLD continue to increase, especially in my country [3-5]. NAFLD is the most common chronic liver disease in the world and the main cause of elevated serum transaminases in healthy people undergoing physical check-ups. It has now replaced viral hepatitis as the largest chronic liver disease in my country [4-5,10]. In addition, NAFLD, metabolic syndrome (MetS) and T2DM are mutually causal, and together promote the development of malignant tumors such as arteriosclerosis cardiovascular disease (CVD), chronic kidney disease (CKD), liver decompensation, and hepatocellular carcinoma (HCC)[1- 2, 6 -7]. To this end, NAFLD has become an increasingly serious public health problem in my country [4,8]. In 2020, the International Fatty Liver Expert Group recommended that NAFLD be renamed metabolic dysfunction-associated fatty liver disease (MAFLD). The Hepatology Branch of the Chinese Medical Association actively stated its position [8], emphasizing that the diagnosis and treatment of NAFLD needs to follow the actual situation in my country. After extensive discussion, it was recommended that the English terms MAFLD and MASLD be translated into "metabolically related fatty liver disease. Diagnosis of MAFLD requires the exclusion of excessive drinking (weekly ethanol intake ≥210g in men and ≥140g in women) and other causes that can lead to fatty liver, and the patient has at least 1 MetS component [1-2]. Patients with suspected MAFLD need to routinely test blood biochemical analysis indicators and evaluate liver steatosis and fibrosis. At the same time, MetS components should be systematically screened and CVD risk should be assessed. Common malignancies and esophageal varices should be screened according to relevant guidelines. Liver biopsy histology is still the gold standard for evaluating liver steatosis and fibrosis [1-2].
MetS, T2DM and NAFLD interact with each other to promote the pathogenesis of metabolization-related diseases in multiple systems and organs across the body. The prognosis of patients with NAFLD is mainly related to CVD and non-hepatic malignancies. Liver related events (liver decompensation, HCC, liver transplantation, or liver-related death) are significantly increased when combined with progressive fibrosis [2,6-7]. MetS is independently associated with increased all-cause mortality and liver and CVD related mortality in patients with NAFLD. T2DM has a greater impact on the prognosis of patients with NAFLD than obesity. Obesity is also a factor that needs to be prevented and managed urgently. Adipose tissue in different parts of the human body is different in anatomy, cells, molecules, etc., so it is of great significance to more accurately measure and divide adipose tissue and muscles in the human body and explore their correlation with renal dysfunction. At present, the research technology using CT or MR images to automatically segment various body components of patients is constantly improving. Therefore, it is also of great significance to accurately assess the metabolic status of patients with metabolism-related fatty liver disease and explore the mechanisms related to metabolism and liver function, which will help doctors make clinical diagnosis and subsequent assisted designation of treatment plans.
Magnetic resonance imaging (MRI) is widely used in medical imaging. Because of its non-invasive nature, high soft tissue resolution and multi-parameter analysis capabilities, it has become a key tool for the assessment and diagnosis of a variety of diseases. MRI can provide high-resolution images of tissue structures and can assess the functional status and metabolic activity of tissue through different imaging sequences, such as T1 and T2 weighted imaging, diffusion weighted imaging (DWI), and magnetization transfer imaging (MT) imaging. These characteristics and the constantly updated new imaging sequences allow MRI to demonstrate great potential in assessing liver disease, especially in non-invasively assessing tissue structure and functional status. MRI can not only display the anatomical structure of an organ in detail, but also monitor the fat fraction and functional status of an organ through multi-parameter imaging technology. For example, magnetic resonance imaging-derived protondensity fat fraction (MRI-PDFF) objectively evaluates the entire liver fat content and has been used in clinical trials to assess changes in liver fat content. MRI-PDFF≥5% and 10% indicate significant and moderate-severe liver steatosis, respectively.
With the advancement of precision medicine and the rapid development of artificial intelligence in recent years, the combination of imagingomics and machine learning technologies has further enhanced the potential of MRI applications. Imagingomics is capable of automating and improving accurate diagnosis through high-throughput image feature extraction combined with machine learning models. These technologies show great potential especially in the staging and grading of metabolism-related fatty liver disease and prognostic assessment, where the accuracy and reliability of the assessment can be significantly improved through the construction of accurate models. Looking forward, the clinical application of CT and MRI technologies in the noninvasive evaluation of patients with metabolic-related fatty liver disease is promising. Their potential to improve patients' quality of life and liver health is enormous. However, current challenges remain, including the diffusion and standardization of the techniques, the accumulation and analysis of data, and the need for multicenter clinical studies. Nonetheless, through continued technological development and research, the use of MRI in the evaluation of patients with metabolism-related fatty liver disease will become more widespread and intensive.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metabolic-Associated Fatty Liver Disease patients | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinically suspected or diagnosed metabolically related fatty liver disease patients
Key inclusion criteria (3 listed)
- Patients with MR examination are clinically suspected or diagnosed with metabolism-related fatty liver disease;
- Age/gender: unlimited;
- Patients who voluntarily participate in clinical trials and sign written subject informed consent
Key exclusion criteria (2 listed)
- Clinical suspicion or diagnosis of metabolism-related fatty liver disease and having been prescribed an MR examination;
- Voluntarily participation in the study and provision of written informed consent.
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
Sensitivity (sensitivity) and specificity (specificity) of MR sequence measurement results vs. liver biopsy (gold standard) translated into English
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
1 secondary outcome
Time from baseline MR scan to development of liver cirrhosis, liver decompensation event, liver cancer, death
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
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 2 Sep 2025.
- Individual participant dataSharing planned: No. protect patient privacy
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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.
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 Nonalcoholic Fatty Liver Disease and Metabolic-associated Fatty Liver Disease, run by Tongji Hospital at 1 site in China.
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 2 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: looking for participants now, as of the sponsor's last update on 2 Sep 2025. 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 China. 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?
Contact Zhen Li (02783663543, zhenli@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (sensitivity) and specificity (specificity) of MR sequence measurement results vs. liver biopsy (gold standard) translated into English (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months). 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 2 Sep 2025.