RecruitingNCT06706856

Quantitative Ultrasound to Assess Steatotic Liver Disease in Children


Sponsor

University of California, San Diego

Enrollment

120 participants

Start Date

Sep 23, 2024

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 9 YearsMax Age: 18 Years

Inclusion Criteria5

  • 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 Criteria3

  • 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.

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Interventions

DIAGNOSTIC_TESTMR exam

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

DIAGNOSTIC_TESTUS 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.

OTHERBlood draw

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

OTHERPhysical 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.

OTHERQuestionnaires

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).


Locations(1)

University of California San Diego

La Jolla, California, United States

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NCT06706856


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