Summary

Eligibility
for people ages 9-18 (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Jeffrey B Schwimmer, MD (ucsd)Claude B Sirlin, MD (ucsd)
Headshot of Claude B Sirlin
Claude B Sirlin

Description

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

Details

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.

Keywords

MASLD, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, steatosis, quantitative ultrasound, quantitative MRI, fat fraction, PDFF, Liver Diseases, MR exam, US exam, Blood draw, Physical measurements

Eligibility

You can join if…

Open to people ages 9-18

  • 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 CAN'T join 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.

Location

  • University of California San Diego accepting new patients
    La Jolla California 92037 United States

Lead Scientists at University of California Health

  • Jeffrey B Schwimmer, MD (ucsd)
    Professor Of Clinical, Pediatrics, Vc-health Sciences-schools. Authored (or co-authored) 158 research publications
  • Claude B Sirlin, MD (ucsd)
    Professor, Radiology, Vc-health Sciences-schools. Authored (or co-authored) 449 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT06706856
Study Type
Observational
Participants
Expecting 120 study participants
Last Updated