Quantitative Ultrasound to Assess Steatotic Liver Disease in Children

NCT06706856 | Recruiting FDA Device

• 2 other identifiers: 8096691R01DK135951-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

MASLD; MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

MASLD; steatosis; quantitative ultrasound; quantitative MRI; fat fraction; PDFF

Outcome Measures

Primary Outcomes (1)

• Development and Evaluation of models for liver fat estimation.

  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

Study Arms (1)

Cohort

This is a single arm study in which all participants undergo the same research procedures.

Diagnostic Test: MR exam; Diagnostic Test: US exam; Other: Blood draw; Other: Physical measurements; Other: Questionnaires

Interventions

MR exam DIAGNOSTIC_TEST

Participants will undergo an advanced magnetic resonance (MR) examination of the abdomen and liver.

Cohort

US exam DIAGNOSTIC_TEST

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.

Cohort

Blood draw OTHER

Participants will undergo a blood draw of approximately 25 mL volume.

Cohort

Physical measurements OTHER

Participants will have their height, weight and waist circumference measured. Vital signs including respiratory frequency, heart rate, temperature, and blood pressure will be measured.

Cohort

Questionnaires OTHER

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).

Cohort

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children being evaluated for MASLD

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Virginia Polytechnic Institute and State University: collaborator
• GE Healthcare: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of California San Diego

La Jolla, California, 92037, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma, blood serum

MeSH Terms

Conditions

Fatty Liver

Interventions

Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jeffrey B Schwimmer, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Claude B Sirlin, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Alba

CONTACT

619-543-5228; amalba@health.ucsd.edu

Gage Tanzman

CONTACT

g1tanzman@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 27, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Start date: 7/1/2025 (anticipated) End date: On or after 7/1/2040 (anticipated)
• 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.

Locations

US (1)