Quantitative Ultrasound to Assess Steatotic Liver Disease in Children

January 18, 2026 updated by: Claude Sirlin, University of California, San Diego

This research study is being conducted to find out more about advanced ultrasound techniques to non-invasively evaluate liver disease in children. The investigators are developing advanced techniques for analyzing ultrasound data and images of the liver, and they will compare it to other established methods used to evaluate the liver, including liver MRI.

The investigators plan to develop and test the advanced analysis techniques using conventional full-size ultrasound machines and, if possible, small handheld devices.

Our goals are:

  • To assess the accuracy of the advanced ultrasound analysis techniques in children
  • To implement and assess these advanced technique on small handheld ultrasound devices, if possible

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Our broad long-term objective is to improve the health of children with metabolic dysfunction-associated steatotic liver disease (MASLD), a condition characterized by accumulation of fat in liver cells, by developing and validating accurate, precise, practical, and widely available tools to detect, measure, and monitor liver fat.

Our study aims to develop advanced quantitative ultrasound (QUS) analysis models for use with full-size US and, if possible, inexpensive point-of-care ultrasound (POCUS) systems in children at risk for MASLD to estimate liver fat fraction and classify presence/absence of fatty liver. We anticipate the models will incorporate technical innovations to improve QUS accuracy and efficiency. To develop and test these models, we plan to enroll 120 children who will undergo ultrasound exams using either full-size or POCUS devices. We plan to compare the performance of our QUS models with liver MRI.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California San Diego
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children being evaluated for MASLD

Description

Inclusion Criteria:

  • Age 9 to 18 years
  • Presence of risk factors for having MASLD
  • Ability and willingness of participant or legal guardian/parent to give written informed consent
  • Participant is willing to give written assent
  • Able and willing to undergo all study procedures

Exclusion Criteria:

  • Known liver disease other than MASLD
  • Pregnant or trying to become pregnant
  • Inability to undergo an MR study: weight exceeding scanner table limit, waist circumference > 140 cm, claustrophobie, and/or metal implants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
This is a single arm study in which all participants undergo the same research procedures.
Diagnostic test: MR exam
Participants will undergo an advanced magnetic resonance (MR) examination of the abdomen and liver.
Diagnostic test: US exam
Participants will undergo an abdominal ultrasound (US) examination using a full-size US system. Some participants may undergo a point-of-care abdominal US exam with a handheld US system, if possible.
Other: Blood draw
Participants will undergo a blood draw of approximately 25 mL volume.
Other: Physical measurements
Participants will have their height, weight and waist circumference measured. Vital signs including respiratory frequency, heart rate, temperature, and blood pressure will be measured.
Other: Questionnaires
Participants will be asked to fill out questionnaires to collect information about their prescribed medications, demographics, medical and surgical histories, prior laboratory results, physical activity and lifestyle measures, and potential alcohol intake (AUDIT questionnaire).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development and Evaluation of models for liver fat estimation.
Time Frame: 5 years
We plan to develop and evaluate models for estimating liver fat fraction and classifying the presence or absence of steatotic liver disease using QUS data.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
GE Healthcare
Virginia Polytechnic Institute and State University

Investigators

  • Principal Investigator: Jeffrey B Schwimmer, MD, University of California, San Diego
  • Principal Investigator: Claude B Sirlin, MD, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2024

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

November 22, 2024

First Posted (Actual)

November 27, 2024

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 809669
  • 1R01DK135951-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified study data and metadata except imaging data will be deposited in the UC San Diego Library Digital Collections Data Repository.

IPD Sharing Time Frame

Start date: 7/1/2025 (anticipated) End date: On or after 7/1/2040 (anticipated)

IPD Sharing Access Criteria

The data repository (containing deidentified study data and metadata except imaging data) will be made public and will be available from the UC San Diego Digital Collections Data Repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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