Quantitative Ultrasound to Assess Steatotic Liver Disease in Children

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

Interventions

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).

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Virginia Polytechnic Institute and State University

  collaborator OTHER

• GE Healthcare

  collaborator INDUSTRY

• University of California, San Diego

  lead OTHER

Principal Investigators

• Jeffrey B Schwimmer, MD · University of California, San Diego

• Claude B Sirlin, MD · University of California, San Diego

Eligibility

Min Age

9 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-23

Primary Completion

2029-02-28

Completion

2029-06-30

FDA Device

Yes

Countries

• United States

Study Locations