MASLDNCT06706856
Quantitative Ultrasound to Assess Steatotic Liver Disease in Children
An observational study of MASLD and MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- MASLD, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- MR exam, US exam and Blood draw
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to 30 Jun 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children being evaluated for MASLD
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gage Tanzman contact
United States1 site, 1 recruiting
- Recruiting
University of California San Diego
La Jolla, California, 92037
Amy Alba, 619-543-5226, amalba@health.ucsd.edu
About this study
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.
Read more
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
Read the detailed description
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.
- Being tested
- MR exam, US exam, Blood draw, Physical measurements, Questionnaires
- Keywords
- MASLD, steatosis, quantitative ultrasound, quantitative MRI, fat fraction, PDFF
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR examDiagnostic test
Participants will undergo an advanced magnetic resonance (MR) examination of the abdomen and liver.
US examDiagnostic test
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 drawOther
Participants will undergo a blood draw of approximately 25 mL volume.
Physical measurementsOther
Participants will have their height, weight and waist circumference measured. Vital signs including respiratory frequency, heart rate, temperature, and blood pressure will be measured.
QuestionnairesOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Cohort | This is a single arm study in which all participants undergo the same research procedures. Receives: Diagnostic Test: MR exam; Diagnostic Test: US exam; Other: Blood draw; Other: Physical measurements; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start23 Sep 2024
- Primary completionFeb 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Virginia Polytechnic Institute and State University, GE Healthcare
- Responsible party
- Principal investigator, Claude Sirlin, University of California, San Diego
- Investigators
- Jeffrey B Schwimmer, MD, Principal investigator, University of California, San DiegoClaude B Sirlin, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706856
- Sponsor's protocol ID
- 809669
- Other IDs
- 1R01DK135951-01
- Status last verified
- Jan 2026
- First submitted
- 22 Nov 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified study data and metadata except imaging data will be deposited in the UC San Diego Library Digital Collections Data Repository.