Non-invasive tests for liver disease in children
Non-Invasive Diagnostic Tests for MASLD in Pediatric Population at an Outpatient Clinic: Velacur and Blood-based Novel Tests
This study is testing a new ultrasound method to see if it can safely and quickly detect liver fat in children and teens who might have liver disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 2 Years to 20 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT06218589 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Velacur ultrasound as a quick, non-invasive diagnostic tool for detecting hepatic steatosis in children and adolescents aged 2 to 20 years. It addresses the rising prevalence of metabolic dysfunction associated steatotic liver disease (MASLD), previously known as non-alcoholic fatty liver disease (NAFLD), which is a significant concern in pediatric populations. The study aims to provide a safer alternative to liver biopsy, which, while accurate, is invasive and carries risks. Participants will undergo Velacur ultrasound, MRI, and blood sample collection to assess liver health and disease presence.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 2-20 years suspected of having MASLD or presenting for liver disease evaluation.
Not a fit: Patients with ascites, pregnancy, or those unable to provide consent or assent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more accessible diagnostic methods for liver disease in children.
How similar studies have performed: Other studies have explored non-invasive diagnostic methods for liver disease, but this specific approach using Velacur ultrasound is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females age 2-20 years with suspicion of MASLD or presenting to liver clinic for evaluation of liver disease, including possible MASLD * For participants choosing to do MRI they have to be able to undergo MRI without sedation * Written/verbal informed consent from parent or legal guardian * Written/verbal informed assent from the child when indicated by age Exclusion Criteria: * Ascites * Pregnancy * Failure to give consent or assent * Have an implanted electronic device such as pacemaker, neurostimulator, or cochlear implant
Where this trial is running
Atlanta, Georgia and 1 other locations
- Children's Healthcare of Atlanta (CHOA) — Atlanta, Georgia, United States (Recruiting)
- Emory Children's Center — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Miriam Vos, MD — Emory University
- Study coordinator: Miriam Vos, MD
- Email: mvos@emory.edu
- Phone: 470-249-3223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.