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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 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

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,496 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are considered the most suitable candidates for participation in this clinical study?

"Patients aged between 2 and 20, who have non-alcoholic fatty liver disease (NAFLD), are eligible to participate in this study. The trial aims to enroll approximately 200 individuals with NAFLD."

Answered by AI

Is the clinical trial open to individuals below the age of 55?

"To be eligible for participation in this clinical trial, potential candidates must fall within the age range of 2 to 20 years old. There are a total of 32 studies available specifically for individuals under the age of 18, while there is a larger pool of 329 studies catering to those over the age of 65."

Answered by AI

Is the enrollment for this research study still ongoing?

"According to the information available on clinicaltrials.gov, this ongoing clinical trial is actively seeking participants. The initial posting date was January 1st, 2024, and it underwent its most recent update on January 12th, 2024."

Answered by AI

What is the upper limit for the number of participants involved in this medical study?

"Indeed, the information on clinicaltrials.gov clearly states that this trial is actively seeking patients. The initial posting of the trial was on January 1st, 2024 and it was most recently revised on January 12th, 2024. The study aims to recruit a total of 200 participants across two distinct locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

Miriam Vos 2024. "Non-Invasive Diagnostic Tests for MASLD in Pediatric Population". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06218589.

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