MASLDNCT07265011
Ultrasound-Based Estimation of Hepatic Steatosis in Pediatric MASLD
A study testing Ultrasound and MRI in people with MASLD and Pediatric, run by Jae Won Choi at 1 site in South Korea.
Trial summary
The purpose of this study is to validate an artificial intelligence (AI)-based algorithm that estimates hepatic steatosis using ultrasound (US) B-mode images in pediatric participants with metabolic dysfunction-associated steatotic liver disease (MASLD). Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- What is being tested?
- Ultrasound and MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Dec 2024to 23 Sep 2025
- Phase
- Interventional
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- participants aged 8 to 18 years clinically indicated for liver ultrasound examination to evaluate hepatic steatosis
- participants with suspected or known metabolic dysfunction-associated steatotic liver disease (MASLD)
- able to understand the study purpose and provide written informed consent (from both participant and legal guardian).
- agree to undergo same-day liver MRI examination in addition to the ultrasound
Who cannot join
- unable to cooperate with imaging procedures
- parent or legal guardian unable to understand the study explanation
- contraindications to MRI
- determined by the investigator to be otherwise unsuitable for participation after consultation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Validation of an AI-Driven Ultrasound-Based Method for Estimating Hepatic Steatosis Using MRI-Derived Fat Fraction as Reference in Pediatric Metabolic Dysfunction-Associated Steatotic Liver Disease
The purpose of this study is to validate an artificial intelligence (AI)-based algorithm that estimates hepatic steatosis using ultrasound (US) B-mode images in pediatric participants with metabolic dysfunction-associated steatotic liver disease (MASLD). The MRI proton density fat fraction (MRI-PDFF) serves as the reference standard for hepatic fat quantification.
- Being tested
- Ultrasound and MRI
- Keywords
- MASLD, NAFLD, Fatty Liver, Pediatrics
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound and MRIDiagnostic test
Participants undergo same-day liver imaging including conventional B-mode ultrasound, quantitative ultrasound, and magnetic resonance imaging (MRI).
Conventional Ultrasound: B-mode imaging performed on three ultrasound systems (Canon Aplio i800, Philips EPIQ, and Supersonic AIXPLORER) to acquire grayscale liver images for artificial intelligence (AI) analysis.
Quantitative Ultrasound: Attenuation imaging (ATI) and shear wave elastography/dispersion measurements performed to assess hepatic fat and stiffness.
MRI: Proton density fat fraction (PDFF) measurement used as the reference standard for hepatic steatosis quantification.
All imaging is performed on the same day for each participant to ensure temporal consistency across modalities and vendors.
| Study group | Role | What they receive |
|---|---|---|
| Liver Ultrasound and MRI | Experimental | Not described Receives: Diagnostic Test: Ultrasound and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between AI-Predicted Ultrasound Fat Fraction (AI-USFF) and MRI Proton Density Fat Fraction (MRI-PDFF)
Reference standard: MRI-PDFF (percentage)
- intraclass correlation coefficient (ICC)
Measured: At time of imaging (single visit)
Secondary outcomes (3)
Correlation Between AI-USFF and MRI-PDFF
Reference standard: MRI-PDFF (percentage)
- Pearson correlation coefficient (r)
Measured: At time of imaging (single visit)
Diagnostic Performance of AI-USFF for MRI-Based Hepatic Steatosis Grades
The diagnostic performance of AI-USFF for detecting mild, moderate, and severe hepatic steatosis, as defined by MRI-PDFF thresholds, will be evaluated using area under the receiver operating characteristic curve (AUC).
Measured: At time of imaging (single visit)
Inter-Vendor Reproducibility of AI-USFF
Reproducibility of AI-USFF across the three ultrasound systems are assessed using the intraclass correlation coefficient (ICC [2,k]).
Measured: At time of imaging (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start31 Dec 2024
- Primary completion23 Sep 2025
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLDStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jae Won Choi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jae Won Choi, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265011
- Sponsor's protocol ID
- SNUH-2312-148-1496
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of an AI-Driven Ultrasound-Based Method for Estimating Hepatic Steatosis Using MRI-Derived Fat Fraction as Reference in Pediatric Metabolic Dysfunction-Associated Steatotic Liver Disease
- ClinicalTrials.gov ID
- NCT07265011
- Acronym / sponsor ID
- SNUH-2312-148-1496
- Keywords
- MASLD, NAFLD, Fatty Liver, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jae Won ChoiUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 4 Dec 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 validate an artificial intelligence (AI)-based algorithm that estimates hepatic steatosis using ultrasound (US) B-mode images in pediatric participants with metabolic dysfunction-associated steatotic liver disease (MASLD). The MRI proton density fat fraction (MRI-PDFF) serves as the reference standard for hepatic fat quantification.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Ultrasound and MRI | Experimental | Diagnostic Test: Ultrasound and MRI |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- participants aged 8 to 18 years clinically indicated for liver ultrasound examination to evaluate hepatic steatosis
- participants with suspected or known metabolic dysfunction-associated steatotic liver disease (MASLD)
- able to understand the study purpose and provide written informed consent (from both participant and legal guardian).
- agree to undergo same-day liver MRI examination in addition to the ultrasound
Key exclusion criteria (4 listed)
- unable to cooperate with imaging procedures
- parent or legal guardian unable to understand the study explanation
- contraindications to MRI
- determined by the investigator to be otherwise unsuitable for participation after consultation
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 |
|---|---|---|
| Ultrasound and MRIParticipants undergo same-day liver imaging including conventional B-mode ultrasound, quantitative ultrasound, and magnetic resonance imaging (MRI). Conventional Ultrasound: B-mode imaging performed on three ultrasound systems (Canon Aplio i800, Philips EPIQ, and Supersonic AIXPLORER) to acquire grayscale liver images for artificial intelligence (AI) analysis. Quantitative Ultrasound: Attenuation imaging (ATI) and shear wave elastography/dispersion measurements performed to assess hepatic fat and stiffness. MRI: Proton density fat fraction (PDFF) measurement used as the reference standard for hepatic steatosis quantification. All imaging is performed on the same day for each participant to ensure temporal consistency across modalities and vendors. | Diagnostic test | Liver Ultrasound and MRI |
Primary outcome
Agreement Between AI-Predicted Ultrasound Fat Fraction (AI-USFF) and MRI Proton Density Fat Fraction (MRI-PDFF)
Time frame: At time of imaging (single visit)
Reference standard: MRI-PDFF (percentage) - intraclass correlation coefficient (ICC)
3 secondary outcomes
Correlation Between AI-USFF and MRI-PDFF
Time frame: At time of imaging (single visit)
Diagnostic Performance of AI-USFF for MRI-Based Hepatic Steatosis Grades
Time frame: At time of imaging (single visit)
Inter-Vendor Reproducibility of AI-USFF
Time frame: At time of imaging (single visit)
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 4 Dec 2025.
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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?
A study testing Ultrasound and MRI in people with MASLD and Pediatric, run by Jae Won Choi at 1 site in South Korea.
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 4 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 4 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 South Korea. 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?
Agreement Between AI-Predicted Ultrasound Fat Fraction (AI-USFF) and MRI Proton Density Fat Fraction (MRI-PDFF) (time frame: At time of imaging (single visit)). 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 4 Dec 2025.