Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

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.

Conditions

• Metabolic Dysfunction Associated Steatotic Liver Disease
• Non-Alcoholic Fatty Liver Disease (NAFLD)

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

• Sonic Incytes

  collaborator INDUSTRY

• The Obesity Society

  collaborator OTHER

• Emory University

  lead OTHER

Principal Investigators

• Miriam Vos, MD · Emory University

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Max Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-18

Primary Completion

2027-02-28

Completion

2027-02-28

FDA Device

Yes

Countries

• United States

Study Locations