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Diagnostic Test

Velacur Ultrasound for Non-alcoholic Fatty Liver Disease

N/A
Recruiting
Led By Miriam Vos, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For participants choosing to do MRI they have to be able to undergo MRI without sedation
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (day of liver ultrasound)
Awards & highlights

Study Summary

This trial is testing a new ultrasound tool called Velacur. The goal is to see if Velacur can quickly and easily detect a liver condition called hepatic steatosis in children and teenagers

Who is the study for?
This trial is for children and adolescents aged 2-20 years who may have a condition called MASLD, which involves fat buildup in the liver. The study will include those likely to have this condition and excludes anyone for whom the tests are not safe or suitable.Check my eligibility
What is being tested?
The trial is testing Velacur ultrasound against standard procedures like liver biopsy, MRI, and blood tests to see if it can effectively diagnose fatty liver disease without being invasive.See study design
What are the potential side effects?
While non-invasive methods like Velacur ultrasound and MRI typically have minimal side effects, there might be discomfort or bruising from blood sample collection. Liver biopsies carry risks of pain, bleeding, and infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can have an MRI without needing to be sedated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (day of liver ultrasound)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (day of liver ultrasound) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Receiver Operating Curve (ROC)
Negative Predictive Values (NPV)
Positive Predictive Value (PPV)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Velacur UltrasoundExperimental Treatment4 Interventions
Patients 2 to 20 years of age with suspicion of MASLD or presenting to liver clinic for evaluation of liver disease, including possible MASLD receiving a Velacur ultrasound.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Velacur
2021
N/A
~70
MRI
2009
Completed Phase 2
~1370
Liver biopsy
2016
N/A
~1180

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,650 Previous Clinical Trials
2,572,454 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
2,707 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Sonic IncytesIndustry Sponsor
5 Previous Clinical Trials
510 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
300 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Miriam Vos, MDPrincipal InvestigatorEmory University
2 Previous Clinical Trials
340 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
340 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~0 spots leftby Jul 2024
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