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Diagnostic Test

Velacur for 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

Must not have

Ascites

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (day of liver ultrasound)

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I can have an MRI without needing to be sedated.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have fluid buildup in my abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (day of liver ultrasound)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area Under the Receiver Operating Curve (ROC)

Negative Predictive Values (NPV)

Positive Predictive Value (PPV)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2810