NAFLDNCT04591106
Quantifying Body Composition and Liver Disease in Children Using Free-Breathing MRI and MRE
An observational study of NAFLD and NASH - Nonalcoholic Steatohepatitis, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Magnetic resonance imaging (MRI) is used to measure liver fat content and fatty tissues in the body, and magnetic resonance elastography (MRE) is used to measure liver stiffness. Read more about this study
- Who is it for?
- Ages 1 week to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD, NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- Magnetic resonance imaging (MRI), Magnetic resonance elastography (MRE) and Prototype MRE soft flexible passive transducer paddle
- Type of treatment
- Medical device
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2021to 28 Feb 2026
- 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 1 week to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Study 1 (Aim 1 and Aim 2): 50 healthy subjects 6-17 years old, 50 subjects with NAFLD 6-17 years old; Study 2 (Aim 3): 60 subjects with Liver Disease and Fibrosis 1 month-40 years old; Study 3 (Aim 4): Study 3 (Aim 4): 15 Pairs of Healthy Infants (1 week-6 months old) and their Mothers. 15 Pairs of Infants (1 week-6 months old) born to Mothers with Gestational Diabetes and their Mothers.
Who may be able to join
- Study 1 (Aim 1 and Aim 2):
- 6-17 years of age
- BMI >85th percentile
- diagnosed or clinically suspected to have NAFLD (NAFLD or suspected NAFLD is defined as serum alanine transaminase concentration >30 IU/L in the appropriate clinical setting)
- ability to follow instructions and perform short breath holds
- 6-17 years of age
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- body mass index <85th percentile
- ability to follow instructions and perform short breath holds
- children and adults 1 month-40 years of age
- liver disease and suspected or confirmed fibrosis
- clinically ordered liver biopsy
- Liver diseases include NAFLD/NASH, viral/medication induced hepatitis, autoimmune sclerosing cholangitis, intestinal failure associated liver disease, idiopathic hepatitis, Wilson's disease, hemosiderosis, liver rejection, and metabolic/genetic disorders
- A liver biopsy must be planned/anticipated, performed, or scheduled to be performed within ±6 months of the MRI/MRE for this study
- 1 week-6 months of age
- greater than or equal to 35 weeks gestational age
- appropriate for gestational age birth weight
- born to a mother with a pre-pregnancy body mass index <25 kg/m2 and without any major co-morbid conditions (gestational diabetes, pregnancy-induced hypertension, etc.)
- admitted to the newborn nursery after birth
- mother must provide consent to participate in the study
Who cannot join
- known liver disease (except for NAFLD/NASH for the NAFLD cohort)
- congenital malformation
- inborn error of metabolism
- contraindications to MRI
- inability to perform breath-holding
- Study 2 (Aim 3):
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- contra-indications to MRI/MRE
- inability to perform breath-holding
- Study 3 (Aim 4):
- Inclusion criteria for the cohort of infants at risk for future obesity and NAFLD:
- 1 week-6 months of age
- greater than or equal to 35 weeks gestational age
- born to a mother with gestational diabetes and whose pre-pregnancy body mass index >=25 kg/m2
- mother must provide consent to participate in the study
- known liver disease and/or infection, major congenital anomalies, inborn error of metabolism
- any contraindications for an MRI exam
Trial locations and contacts
1 site in 1 country.
About this study
Magnetic resonance imaging (MRI) is used to measure liver fat content and fatty tissues in the body, and magnetic resonance elastography (MRE) is used to measure liver stiffness. The information from MRI and MRE are used to understand risk factors and diagnose liver diseases, such as fatty liver disease and liver fibrosis. However, current MRI and MRE scans need to be performed during a breath-hold, which may be challenging or impossible in children and infants. The goal of this research project is to develop and evaluate new free-breathing MRI and MRE technology to improve the comfort and diagnostic accuracy for children and infants.
Read the detailed description
More than 13.7 million children in the U.S. are obese, and all are at high risk for non-alcoholic fatty liver disease (NAFLD), which can lead to fibrosis and progress to liver failure. NAFLD is the most common chronic pediatric liver disease and number one indication for liver transplant in young adults. Accurate assessments of visceral adipose tissue and hepatic fat and fibrosis are critical to the understanding, early diagnosis, and evaluation of new treatments for pediatric obesity and NAFLD. However, there is a lack of child-appropriate technologies to quantify visceral adipose tissue and hepatic fat and fibrosis. Conventional imaging techniques for body composition involve radiation and do not measure individual adipose tissue compartments. Although liver biopsy is the gold standard for diagnosis, this procedure is invasive, requires anesthesia and has complications. Moreover, biopsy findings can be non-specific and suffer from sampling bias and interpretation variability.
Magnetic resonance imaging and elastography (MRI and MRE) are promising non-invasive technologies. MRI quantifies visceral adipose tissue and hepatic fat. MRE quantifies hepatic fibrosis. MRI and MRE do not require ionizing radiation or biopsy. However, current MRI/MRE technology is not appropriate for most children and infants because it requires breath-holding to limit abdominal motion. In young children and infants, breath-holding is not possible. Even in children who can breath-hold, inconsistency and reduced capacity in breath-holding leads to long scan times, corrupted images, failed scans, and unreliable results. Although sedation can facilitate breath-holding, it is associated with negative side effects. As a result, current MRI/MRE technologies typically exclude many children.
To overcome these limitations, the research team created new free-breathing (FB) 3D stack-of-radial MRI technology to quantify visceral adipose tissue and hepatic fat in children and infants. The research team has also developed new 2D radial FB-MRE technology to quantify hepatic fibrosis in children. The objectives of this project are to further develop and evaluate FB-MRI/MRE. The research team will reduce FB-MRI/MRE scan times while maintaining high image quality, demonstrate a high level of accuracy and precision, validate FB-MRI/MRE results against biopsy, and test FB-MRI in a population that cannot breath-hold. The research team will leverage innovations in simultaneous multi-slice imaging, sparsity-constrained tensor image reconstruction, and self-navigation to investigate four aims:
Aim 1. Develop new radial FB-MRI/MRE technologies that quantify visceral adipose tissue and hepatic fat and fibrosis with rapid scan times (1-2 min) and minimal motion artifacts,
Aim 2. Measure the accuracy and precision of the new FB-MRI/MRE for quantifying these biomarkers,
Aim 3. Compare the FB-MRI/MRE biomarkers to liver biopsy in children with liver disease,
Aim 4. Test new FB-MRI technology in infants.
The innovative radial FB-MRI/MRE technology will reliably quantify body composition and liver disease in children and infants. In turn, FB-MRI/MRE will improve the early diagnosis, treatment monitoring, and understanding and management of pediatric obesity, NAFLD, and other liver diseases.
- Conditions
- NAFLD, NASH - Nonalcoholic Steatohepatitis
- Being tested
- Magnetic resonance imaging (MRI), Magnetic resonance elastography (MRE), Prototype MRE soft flexible passive transducer paddle
- Keywords
- MRI, pediatric, liver, fibrosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Diagnostic test
Magnetic resonance imaging (MRI) is a non-invasive imaging technique that uses a magnetic field and radio waves to create detailed images of the organs and tissues within the body.
Magnetic resonance elastography (MRE)Diagnostic test
Magnetic resonance elastography (MRE) is a non-invasive imaging technique that uses a gently vibrating transducer in combination with MRI to create detailed images and maps of the mechanical properties, such as stiffness, of tissues within the body.
Prototype MRE soft flexible passive transducer paddleDevice
Also called MRE transducer paddle
The prototype device is provided to the investigators by Mayo Clinic under a Materials Transfer Agreement (MTA). The device is being used to promote comfort in the pediatric population; no formal data collection for regulatory submission is planned. The prototype device is smaller, softer, and more flexible than the commercial device and will be used where indicated by the subjects' size.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 50 healthy subjects and 50 subjects with NAFLD between ages of 6-17 years old. Each subject will receive 1 MRI/MRE exam. The MRE portion will be performed by placing a paddle on the belly that will produce gentle vibrations. Receives: Diagnostic Test: Magnetic resonance imaging (MRI); Diagnostic Test: Magnetic resonance elastography (MRE); Device: Prototype MRE soft flexible passive transducer paddle | |
| Group 2 | 60 subjects with Liver Disease and Fibrosis between ages of 1 month - 40 years old.
Each subject will receive 1 MRI/MRE exam. The MRE portion will be performed by placing a paddle on the belly that will produce gentle vibrations. Receives: Diagnostic Test: Magnetic resonance imaging (MRI); Diagnostic Test: Magnetic resonance elastography (MRE); Device: Prototype MRE soft flexible passive transducer paddle | |
| Group 3 | 15 healthy infants between 1 week - 6 months old and their mothers; 15 at-risk infants (mother had gestational diabetes) between 1 week - 6 months old and their mothers. Each infant will receive 1 MRI scan. Receives: Diagnostic Test: Magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Proton Density Fat Fraction (PDFF) by MRI
Liver proton density fat fraction (PDFF; 0 to 100%) is an MRI based measurement of liver fat content. The liver PDFF measured by the new free-breathing MRI technique will be compared with standard breath-holding MRI in terms of the concordance correlation coefficient. The repeatability of liver PDFF will be measured in terms of the coefficient of variation between two scans. In addition, the diagnostic performance of MRI liver PDFF to detect liver fat will be validated against liver biopsy.
Measured: 4 years
Abdominal Visceral Adipose Tissue (VAT) Volume by MRI
Visceral adipose tissue (VAT) volume (cm3) in the abdomen is an MRI based measurement of body composition. The VAT volume measured by the new free-breathing MRI technique will be compared with standard breath-holding MRI in terms of the concordance correlation coefficient. The repeatability of VAT volume will be measured in terms of the coefficient of variation between two scans.
Measured: 4 years
Liver Tissue Stiffness by MRE
Liver tissue stiffness (kPa) measured by MRE correlates with liver fibrosis. The liver tissue stiffness measured by the new free-breathing MRE technique will be compared with standard breath-holding MRE in terms of the concordance correlation coefficient. The repeatability of liver tissue stiffness will be measured in terms of the coefficient of variation between two scans. In addition, the diagnostic performance of MRE liver tissue stiffness to detect liver fibrosis will be validated against liver biopsy.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start17 Feb 2021
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Holden H. Wu, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591106
- Sponsor's protocol ID
- Pediatric Free-Breathing MR
- Other IDs
- R01DK124417
- Status last verified
- Mar 2026
- First submitted
- 13 Oct 2020
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Body Composition and Liver Disease in Children Using Free-Breathing MRI and MRE
- ClinicalTrials.gov ID
- NCT04591106
- Acronym / sponsor ID
- Pediatric Free-Breathing MR
- Conditions
- NAFLD, NASH - Nonalcoholic Steatohepatitis
- Keywords
- MRI, pediatric, liver, fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 19 Oct 2020 (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.
Magnetic resonance imaging (MRI) is used to measure liver fat content and fatty tissues in the body, and magnetic resonance elastography (MRE) is used to measure liver stiffness. The information from MRI and MRE are used to understand risk factors and diagnose liver diseases, such as fatty liver disease and liver fibrosis. However, current MRI and MRE scans need to be performed during a breath-hold, which may be challenging or impossible in children and infants. The goal of this research project is to develop and evaluate new free-breathing MRI and MRE technology to improve the comfort and diagnostic accuracy for children and infants.
Detailed description
More than 13.7 million children in the U.S. are obese, and all are at high risk for non-alcoholic fatty liver disease (NAFLD), which can lead to fibrosis and progress to liver failure. NAFLD is the most common chronic pediatric liver disease and number one indication for liver transplant in young adults. Accurate assessments of visceral adipose tissue and hepatic fat and fibrosis are critical to the understanding, early diagnosis, and evaluation of new treatments for pediatric obesity and NAFLD. However, there is a lack of child-appropriate technologies to quantify visceral adipose tissue and hepatic fat and fibrosis. Conventional imaging techniques for body composition involve radiation and do not measure individual adipose tissue compartments. Although liver biopsy is the gold standard for diagnosis, this procedure is invasive, requires anesthesia and has complications. Moreover, biopsy findings can be non-specific and suffer from sampling bias and interpretation variability.
Magnetic resonance imaging and elastography (MRI and MRE) are promising non-invasive technologies. MRI quantifies visceral adipose tissue and hepatic fat. MRE quantifies hepatic fibrosis. MRI and MRE do not require ionizing radiation or biopsy. However, current MRI/MRE technology is not appropriate for most children and infants because it requires breath-holding to limit abdominal motion. In young children and infants, breath-holding is not possible. Even in children who can breath-hold, inconsistency and reduced capacity in breath-holding leads to long scan times, corrupted images, failed scans, and unreliable results. Although sedation can facilitate breath-holding, it is associated with negative side effects. As a result, current MRI/MRE technologies typically exclude many children.
To overcome these limitations, the research team created new free-breathing (FB) 3D stack-of-radial MRI technology to quantify visceral adipose tissue and hepatic fat in children and infants. The research team has also developed new 2D radial FB-MRE technology to quantify hepatic fibrosis in children. The objectives of this project are to further develop and evaluate FB-MRI/MRE. The research team will reduce FB-MRI/MRE scan times while maintaining high image quality, demonstrate a high level of accuracy and precision, validate FB-MRI/MRE results against biopsy, and test FB-MRI in a population that cannot breath-hold. The research team will leverage innovations in simultaneous multi-slice imaging, sparsity-constrained tensor image reconstruction, and self-navigation to investigate four aims:
Aim 1. Develop new radial FB-MRI/MRE technologies that quantify visceral adipose tissue and hepatic fat and fibrosis with rapid scan times (1-2 min) and minimal motion artifacts,
Aim 2. Measure the accuracy and precision of the new FB-MRI/MRE for quantifying these biomarkers,
Aim 3. Compare the FB-MRI/MRE biomarkers to liver biopsy in children with liver disease,
Aim 4. Test new FB-MRI technology in infants.
The innovative radial FB-MRI/MRE technology will reliably quantify body composition and liver disease in children and infants. In turn, FB-MRI/MRE will improve the early diagnosis, treatment monitoring, and understanding and management of pediatric obesity, NAFLD, and other liver diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Magnetic resonance imaging (MRI), Diagnostic Test: Magnetic resonance elastography (MRE), Device: Prototype MRE soft flexible passive transducer paddle50 healthy subjects and 50 subjects with NAFLD between ages of 6-17 years old. Each subject will receive 1 MRI/MRE exam. The MRE portion will be performed by placing a paddle on the belly that will produce gentle vibrations. |
| Group 2 | – | Diagnostic Test: Magnetic resonance imaging (MRI), Diagnostic Test: Magnetic resonance elastography (MRE), Device: Prototype MRE soft flexible passive transducer paddle60 subjects with Liver Disease and Fibrosis between ages of 1 month - 40 years old. Each subject will receive 1 MRI/MRE exam. The MRE portion will be performed by placing a paddle on the belly that will produce gentle vibrations. |
| Group 3 | – | Diagnostic Test: Magnetic resonance imaging (MRI)15 healthy infants between 1 week - 6 months old and their mothers; 15 at-risk infants (mother had gestational diabetes) between 1 week - 6 months old and their mothers. Each infant will receive 1 MRI scan. |
Who may qualify
- Ages
- 1 week to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study 1 (Aim 1 and Aim 2): 50 healthy subjects 6-17 years old, 50 subjects with NAFLD 6-17 years old; Study 2 (Aim 3): 60 subjects with Liver Disease and Fibrosis 1 month-40 years old; Study 3 (Aim 4): Study 3 (Aim 4): 15 Pairs of Healthy Infants (1 week-6 months old) and their Mothers. 15 Pairs of Infants (1 week-6 months old) born to Mothers with Gestational Diabetes and their Mothers.
Key inclusion criteria (19 listed)
- 6-17 years of age
- BMI >85th percentile
- diagnosed or clinically suspected to have NAFLD (NAFLD or suspected NAFLD is defined as serum alanine transaminase concentration >30 IU/L in the appropriate clinical setting)
- ability to follow instructions and perform short breath holds
- 6-17 years of age
Key exclusion criteria (16 listed)
- known liver disease (except for NAFLD/NASH for the NAFLD cohort)
- congenital malformation
- inborn error of metabolism
- contraindications to MRI
- inability to perform breath-holding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imaging (MRI)Magnetic resonance imaging (MRI) is a non-invasive imaging technique that uses a magnetic field and radio waves to create detailed images of the organs and tissues within the body. | Diagnostic test | Group 1, Group 2, Group 3 |
| Magnetic resonance elastography (MRE)Magnetic resonance elastography (MRE) is a non-invasive imaging technique that uses a gently vibrating transducer in combination with MRI to create detailed images and maps of the mechanical properties, such as stiffness, of tissues within the body. | Diagnostic test | Group 1, Group 2 |
| Prototype MRE soft flexible passive transducer paddleAlso: MRE transducer paddleThe prototype device is provided to the investigators by Mayo Clinic under a Materials Transfer Agreement (MTA). The device is being used to promote comfort in the pediatric population; no formal data collection for regulatory submission is planned. The prototype device is smaller, softer, and more flexible than the commercial device and will be used where indicated by the subjects' size. | Device | Group 1, Group 2 |
Primary outcome
Liver Proton Density Fat Fraction (PDFF) by MRI
Time frame: 4 years
Liver proton density fat fraction (PDFF; 0 to 100%) is an MRI based measurement of liver fat content. The liver PDFF measured by the new free-breathing MRI technique will be compared with standard breath-holding MRI in terms of the concordance correlation coefficient. The repeatability of liver PDFF will be measured in terms of the coefficient of variation between two scans. In addition, the diagnostic performance of MRI liver PDFF to detect liver fat will be validated against liver biopsy.
Abdominal Visceral Adipose Tissue (VAT) Volume by MRI
Time frame: 4 years
Visceral adipose tissue (VAT) volume (cm3) in the abdomen is an MRI based measurement of body composition. The VAT volume measured by the new free-breathing MRI technique will be compared with standard breath-holding MRI in terms of the concordance correlation coefficient. The repeatability of VAT volume will be measured in terms of the coefficient of variation between two scans.
Liver Tissue Stiffness by MRE
Time frame: 4 years
Liver tissue stiffness (kPa) measured by MRE correlates with liver fibrosis. The liver tissue stiffness measured by the new free-breathing MRE technique will be compared with standard breath-holding MRE in terms of the concordance correlation coefficient. The repeatability of liver tissue stiffness will be measured in terms of the coefficient of variation between two scans. In addition, the diagnostic performance of MRE liver tissue stiffness to detect liver fibrosis will be validated against liver biopsy.
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 10 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 NAFLD and NASH - Nonalcoholic Steatohepatitis, run by University of California, Los Angeles at 1 site in United States.
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 19 inclusion and 16 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 10 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 United States. 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?
Liver Proton Density Fat Fraction (PDFF) by MRI (time frame: 4 years). The study lists 3 primary outcomes in all. 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 10 Mar 2026.