NAFLDNCT06354491
An Imaging-based Quantitative Biomarker Assay for NAFLD in Children
A study testing Magnetic Resonance Imaging (MRI) and Ultrasound (US) in people with NAFLD and NASH, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study will validate recently developed Magnetic Resonance Imaging (MRI) and Ultrasound (US) based methods for liver fat quantification in children with obesity and healthy range of body mass index (BMI). Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- What is being tested?
- Magnetic Resonance Imaging (MRI) and Ultrasound (US)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 1 Jul 2028
- Phase
- Interventional
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: 10 - 14years old
- BMI: Case subjects: BMI>95th percentile for age and sex Healthy BMI volunteers: 5th ≤ BMI < 85th percentile for age and sex
Who cannot join
- Children with contraindications to MRI.
- Children who did not fast (verbally confirmed by children or guardian)
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin, Madison
Madison, Wisconsin, 53705
About this study
Official title: An Imaging-based Quantitative Biomarker Assay for Non-alcoholic Fatty Liver Disease (NAFLD) in Children: a Feasibility Study
This study will validate recently developed Magnetic Resonance Imaging (MRI) and Ultrasound (US) based methods for liver fat quantification in children with obesity and healthy range of body mass index (BMI).
Read the detailed description
The severity of the obesity epidemic in the U.S., particularly in Wisconsin, is alarming, with overall overweight or obesity rates of 35% in children. [Fryar 2020,] Obesity is a major risk factor for several comorbidities, one of the most common being non-alcoholic fatty liver disease (NAFLD, also denoted steatotic liver disease). The inflammatory state known as non-alcoholic steatohepatitis (NASH) may lead to fibrosis and, if left untreated, can lead to cirrhosis, liver failure, and cancer. For these reasons, there is enormous interest in effective interventions for weight loss and reversing NAFLD. A central challenge in the development of new interventions is the need for accurate and precise biomarkers to evaluate hepatic steatosis in children.
This pilot study focuses on demonstrating the feasibility of MRI and US based liver fat quantification in children and addresses technical challenges that may limit the performance of the proposed techniques in the population of interest through the following aims:
- Aim 1: Determine the bias and precision (repeatability) of emerging free-breathing MRI-based liver fat quantification in children with obesity and controls using current breath-held methods as a reference.
- Aim 2: Determine the precision (repeatability and reproducibility) of US-based biomarkers of liver steatosis with a focus on the impact of body wall thickness on the precision of the biomarkers.
- Being tested
- Magnetic Resonance Imaging (MRI), Ultrasound (US)
- 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.
Magnetic Resonance Imaging (MRI)Device
MRI procedures will include a 20-25 minute exam with periodic breath holds. The imaging series will be conducted twice to assess repeatability.
Ultrasound (US)Device
In each ultrasound exam, each participant will be scanned by twice by the same sonographer to evaluate intra-operator variability (repeatability). Each exam will take approximately 60 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Average or low BMI | Experimental | Children with BMI under the 85th percentile for age and sex Receives: Device: Magnetic Resonance Imaging (MRI); Device: Ultrasound (US) |
| High BMI | Experimental | Children with BMI in the 95th percentile or higher for age and sex Receives: Device: Magnetic Resonance Imaging (MRI); Device: Ultrasound (US) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Measured by the Number of Participants Who Successfully Complete the Interventions
Demonstrate the feasibility of MRI- and US-based liver fat quantification in children and address technical challenges that may limit the performance of the proposed techniques in the population of interest.
Measured: through study enrollment (up to approximately 14 months)
Secondary outcomes (6)
MRI: Bias reported as difference in mean error in Percent Liver Fat measured from free-breathing MRI method and reference breath-held MRI method
To validate and confirm the reliability of a recently developed free-breathing CSE-based PDFF mapping method in children with high and average/low BMI for age and sex, bias is reported. Bias is defined as the mean error in liver PDFF measurements between the new free-breathing MRI method and the reference breath-held MRI method, reported in percentage.
Measured: Research visit 1 (up to 14 months)
MRI: Precision measured by Test-Retest of Percent Liver Fat
To validate and confirm the reliability of a recently developed free-breathing CSE-based PDFF mapping method in children with high and average/low BMI for age and sex, precision will be assessed.
Precision (test-retest repeatability) for each acquisition method and within each liver segment will be calculated through the coefficient of repeatability.
Measured: Research visit 1 (up to 14 months)
Quantitative US: Repeatability of US Measurements (same sonographer) - Attenuation Coefficient (dB/cm-MHz)
Biomarkers of liver steatosis are measured and analyzed for their repeatability by the same sonographer in the high and healthy BMI cohorts.
Measured: Research visit 1 (up to 14 months)
Quantitative US: Repeatability of US Measurements (same sonographer) - Backscatter Coefficient (1/cm*sr)
Biomarkers of liver steatosis are measured and analyzed for their repeatability by the same sonographer in the high and healthy BMI cohorts.
Measured: Research visit 1 (up to 14 months)
Quantitative US: Reproducibility of US Measurements (different sonographers) - Attenuation Coefficient (dB/cm-MHz)
Biomarkers of liver steatosis are measured and analyzed for their reproducibility between different sonographers in the healthy BMI cohort.
Measured: Research visit 1 (up to 14 months)
Quantitative US: Reproducibility of US Measurements (different sonographers) - Backscatter Coefficient (1/cm*sr)
Biomarkers of liver steatosis are measured and analyzed for their reproducibility between different sonographers in the healthy BMI cohort.
Measured: Research visit 1 (up to 14 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Apr 2024
- Primary completion20 Jun 2025
- Study completion1 Jul 2028 (estimated)
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 Wisconsin, MadisonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivan Rosado-Mendez, PhD, Principal investigator, University of Wisconsin, MadisonDiego Hernando, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354491
- Sponsor's protocol ID
- 2023-1494
- Other IDs
- A534800, Protocol Version 12/19/24
- Status last verified
- Dec 2025
- First submitted
- 3 Apr 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Imaging-based Quantitative Biomarker Assay for Non-alcoholic Fatty Liver Disease (NAFLD) in Children: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06354491
- Acronym / sponsor ID
- 2023-1494
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 9 Apr 2024 (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.
This study will validate recently developed Magnetic Resonance Imaging (MRI) and Ultrasound (US) based methods for liver fat quantification in children with obesity and healthy range of body mass index (BMI).
Detailed description
The severity of the obesity epidemic in the U.S., particularly in Wisconsin, is alarming, with overall overweight or obesity rates of 35% in children. [Fryar 2020,] Obesity is a major risk factor for several comorbidities, one of the most common being non-alcoholic fatty liver disease (NAFLD, also denoted steatotic liver disease). The inflammatory state known as non-alcoholic steatohepatitis (NASH) may lead to fibrosis and, if left untreated, can lead to cirrhosis, liver failure, and cancer. For these reasons, there is enormous interest in effective interventions for weight loss and reversing NAFLD. A central challenge in the development of new interventions is the need for accurate and precise biomarkers to evaluate hepatic steatosis in children.
This pilot study focuses on demonstrating the feasibility of MRI and US based liver fat quantification in children and addresses technical challenges that may limit the performance of the proposed techniques in the population of interest through the following aims:
- Aim 1: Determine the bias and precision (repeatability) of emerging free-breathing MRI-based liver fat quantification in children with obesity and controls using current breath-held methods as a reference.
- Aim 2: Determine the precision (repeatability and reproducibility) of US-based biomarkers of liver steatosis with a focus on the impact of body wall thickness on the precision of the biomarkers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Average or low BMI | Experimental | Device: Magnetic Resonance Imaging (MRI), Device: Ultrasound (US)Children with BMI under the 85th percentile for age and sex |
| High BMI | Experimental | Device: Magnetic Resonance Imaging (MRI), Device: Ultrasound (US)Children with BMI in the 95th percentile or higher for age and sex |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age: 10 - 14years old
- BMI: Case subjects: BMI>95th percentile for age and sex Healthy BMI volunteers: 5th ≤ BMI < 85th percentile for age and sex
Key exclusion criteria (3 listed)
- Children with contraindications to MRI.
- Children who did not fast (verbally confirmed by children or guardian)
- Pregnant
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)MRI procedures will include a 20-25 minute exam with periodic breath holds. The imaging series will be conducted twice to assess repeatability. | Device | Average or low BMI, High BMI |
| Ultrasound (US)In each ultrasound exam, each participant will be scanned by twice by the same sonographer to evaluate intra-operator variability (repeatability). Each exam will take approximately 60 minutes to complete. | Device | Average or low BMI, High BMI |
Primary outcome
Feasibility Measured by the Number of Participants Who Successfully Complete the Interventions
Time frame: through study enrollment (up to approximately 14 months)
Demonstrate the feasibility of MRI- and US-based liver fat quantification in children and address technical challenges that may limit the performance of the proposed techniques in the population of interest.
6 secondary outcomes
MRI: Bias reported as difference in mean error in Percent Liver Fat measured from free-breathing MRI method and reference breath-held MRI method
Time frame: Research visit 1 (up to 14 months)
MRI: Precision measured by Test-Retest of Percent Liver Fat
Time frame: Research visit 1 (up to 14 months)
Quantitative US: Repeatability of US Measurements (same sonographer) - Attenuation Coefficient (dB/cm-MHz)
Time frame: Research visit 1 (up to 14 months)
Quantitative US: Repeatability of US Measurements (same sonographer) - Backscatter Coefficient (1/cm*sr)
Time frame: Research visit 1 (up to 14 months)
Quantitative US: Reproducibility of US Measurements (different sonographers) - Attenuation Coefficient (dB/cm-MHz)
Time frame: Research visit 1 (up to 14 months)
Quantitative US: Reproducibility of US Measurements (different sonographers) - Backscatter Coefficient (1/cm*sr)
Time frame: Research visit 1 (up to 14 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 17 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Ivan Rosado-Mendez, PhD principal investigator
University of Wisconsin, Madison
Diego Hernando, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging (MRI) and Ultrasound (US) in people with NAFLD and NASH, run by University of Wisconsin, Madison 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 2 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 17 Dec 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 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?
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?
Feasibility Measured by the Number of Participants Who Successfully Complete the Interventions (time frame: through study enrollment (up to approximately 14 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 17 Dec 2025.