NCT06706856

Quantitative Ultrasound to Assess Steatotic Liver Disease in Children

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 9 Years – 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2024-09-23
• Primary completion: 2029-02-01
• Completion: 2029-06-30
• First posted: 2024-11-27
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study