Quantitative Ultrasound to Assess Steatotic Liver Disease in Children

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06706856
Status
Recruiting
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Conditions

  • MASLD
  • MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Eligibility Criteria

Sex
ALL
Age
9 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • MR exam — DIAGNOSTIC_TEST
    Participants will undergo an advanced magnetic resonance (MR) examination of the abdomen and liver.
  • 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.
  • Blood draw — OTHER
    Participants will undergo a blood draw of approximately 25 mL volume.
  • 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.
  • 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).

Study Details

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

Key Dates

Start date
Sep 23, 2024
Status verified
Jan 2026
Primary completion
Feb 28, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
120 participants (estimated)

Arms

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92037
Amy Alba
[email protected]
619-543-5226

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