Quantitative Ultrasound to Assess Steatotic Liver Disease in Children
NCT ID: NCT06706856
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2024-09-23
2029-06-30
Brief Summary
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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
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort
This is a single arm study in which all participants undergo the same research procedures.
MR exam
Participants will undergo an advanced magnetic resonance (MR) examination of the abdomen and liver.
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.
Blood draw
Participants will undergo a blood draw of approximately 25 mL volume.
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.
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).
Interventions
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MR exam
Participants will undergo an advanced magnetic resonance (MR) examination of the abdomen and liver.
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.
Blood draw
Participants will undergo a blood draw of approximately 25 mL volume.
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.
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).
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
9 Years
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Virginia Polytechnic Institute and State University
OTHER
GE Healthcare
INDUSTRY
University of California, San Diego
OTHER
Responsible Party
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Claude Sirlin
Professor of Radiology
Principal Investigators
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Jeffrey B Schwimmer, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Claude B Sirlin, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of California San Diego
La Jolla, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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809669
Identifier Type: -
Identifier Source: org_study_id