Clinical trial NCT06706856: Quantitative Ultrasound to Assess Steatotic Liver Disease in Children
Official title: Quantitative Ultrasound to Assess Steatotic Liver Disease in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: MASLD
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Keywords: MASLD
steatosis
quantitative ultrasound
quantitative MRI
fat fraction
PDFF
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Virginia Polytechnic Institute and State University
name: GE Healthcare
First posted: 2024-11-27
Enrollment: 120
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children being evaluated for MASLD

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Development and Evaluation of models for liver fat estimation.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Jeffrey B Schwimmer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Claude B Sirlin, MD
role: PRINCIPAL_INVESTIGATOR
References: