University of California San Diego
La Jolla, California, 92037, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06706856
Quantitative Ultrasound to Assess Steatotic Liver Disease in Children
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
9 year–18 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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.
Treatment and study plan
MR exam
Diagnostic TestParticipants will undergo an advanced magnetic resonance (MR) examination of the abdomen and liver.
US exam
Diagnostic TestParticipants 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
OtherParticipants will undergo a blood draw of approximately 25 mL volume.
Physical measurements
OtherParticipants will have their height, weight and waist circumference measured. Vital signs including respiratory frequency, heart rate, temperature, and blood pressure will be measured.
questionnaires
OtherParticipants 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).
Primary outcomes
-
Development and Evaluation of models for liver fat estimation.
Time frame: 5 years
We plan to develop and evaluate models for estimating liver fat fraction and classifying the presence or absence of steatotic liver disease using QUS data.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of California, San Diego
Other
Collaborators
- GE Healthcare
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Virginia Polytechnic Institute and State University
Registry information
Important dates
- Study start
- 2024
- Primary completion
- 2029
- Study completion
- 2029
- First posted
- Nov 27, 2024
- Registry last updated
- Jan 21, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Recruiting
Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease
NCT04873258
Body Weight, Digestive System Diseases
London, United Kingdom
View Trial Details
Enrolling by Invitation
Effect of an Early Time Restricted Eating Mediterranean Diet Compared to Naltrexone/Bupropion on Liver Fibrosis in People With Cardiometabolic Risk Factors in a Hospital Outpatient Clinic (MEDFAST-study)
NCT06845345
Behavior, Body Weight
Rotterdam, Netherlands
View Trial Details
Recruiting
Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial
NCT06138821
Body Weight, Body Weight Changes
Boston, Massachusetts, United States
View Trial Details
Recruiting
Effects of Peanut Consumption on Adults With Metabolic Associated Fatty Liver Disease
NCT07646197
Digestive System Diseases, Fatty Liver
Detroit, Michigan, United States
View Trial Details