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Non-Invasive Diagnostic Tests for MASLD in Pediatric Population
Sponsor: Emory University
Summary
This study aims to test the utility of Velacur ultrasound as a non-invasive, rapid, point of care diagnostic tool for detecting the presence and amount of hepatic steatosis in children and adolescents aged 2 - 20 years.
Official title: Non-Invasive Diagnostic Tests for MASLD in Pediatric Population at an Outpatient Clinic: Velacur and Blood-based Novel Tests
Key Details
Gender
All
Age Range
2 Years - 20 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-01-18
Completion Date
2027-02
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Velacur
Velacur is a liver ultrasound that measures hepatic fat and fibrosis through the propagation of a continuously, externally conducted shear wave. An enrolled participant may choose to do the ultrasound at the time of a clinic visit, or research visit or a scheduled radiology visit according to manufacturer's instructions by trained study staff. Fibrosis and steatosis measures will be collected from all scans.
MRI
Participants who have not had an MRI within the past two years will be offered a research MRI (no contrast or sedation will be used) to measure hepatic fat and hepatic stiffness (if required). Participants who have had an MRI or liver biopsy in the past two years will use historical data comparison data. MRI data will include the PDFF hepatic fat, any assessment of fibrosis and notes of other abnormalities.
Blood sample collection for biomarkers
Biomarkers are metabolic thumbprints of how the body is behaving to different health or disease processes, some of the biomarkers can be studied from plasma or serum combined with other demographics. A lipid profile and comprehensive metabolic panel (CMP), if not obtained clinically within 4 weeks, will be collected as a standard of care.
Liver biopsy
Liver biopsy data will be collected only if liver biopsy is done clinically when available and scored using the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) approach.
Locations (2)
Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, United States
Emory Children's Center
Atlanta, Georgia, United States