Quantitative Ultrasound to Assess Steatotic Liver Disease in Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age9-18
SponsorUniversity of California, San Diego
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Children being evaluated for MASLD
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
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
Other interventionParticipants will undergo a blood draw of approximately 25 mL volume.
Physical measurements
Other interventionParticipants will have their height, weight and waist circumference measured. Vital signs including respiratory frequency, heart rate, temperature, and blood pressure will be measured.
Questionnaires
Other interventionParticipants 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).
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Cohort5 interventions
Trial outcomes
Primary outcomes
1
Development and Evaluation of models for liver fat estimation.
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.
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Diego
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Virginia Polytechnic Institute and State University
Collaborator
GE Healthcare
Collaborator
Source ClinicalTrials.gov