Recruiting

Quantitative Ultrasound

Sponsor:

UCLA

Code:

NCT06706856

Conditions

MASLD

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Eligibility Criteria

Sex: All

Age: 9 - 18

Healthy Volunteers: Not accepted

Interventions

MR exam

US exam

Blood draw

Physical measurements

Questionnaires

Study Details

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

Study ID

NCT06706856

Start date

Sep 23, 2024

Status verified date

Jan, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort

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

Interventions

MR exam

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

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.

Blood draw

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

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.

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).

Primary outcome measure

  • Development and Evaluation of models for liver fat estimation. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Amy Alba

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

Gage Tanzman

g1tanzman@health.ucsd.edu

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

Amy Alba

619-543-5226amalba@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-01-21.