NCT06218589

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jan 2024Feb 2027

First Submitted

Initial submission to the registry

January 12, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

January 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

January 12, 2024

Last Update Submit

April 2, 2026

Conditions

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

Keywords

Pediatrics

Outcome Measures

Primary Outcomes (6)

  • Sensitivity of Detecting MASLD

    The performance of Velacur is assessed as the percentage of correctly identified cases of MASLD (true positives) detected by Velacur imaging. The presence of MASLD will be compared with the determinations from MRI and liver biopsy, the current gold standards.

    Day 1 (day of liver ultrasound)

  • Specificity of Detecting MASLD

    The performance of Velacur is assessed as the percentage of correctly identified lack of MASLD (true negatives) detected by Velacur imaging. The presence of MASLD will be compared with the determinations from MRI and liver biopsy, the current gold standards.

    Day 1 (day of liver ultrasound)

  • Positive Predictive Value (PPV)

    The Positive Predictive Value (PPV) is the ratio of participants who are truly positive for MASLD divided by the number of participants who test positive for MASLD (true positives and false positives).

    Day 1 (day of liver ultrasound)

  • Negative Predictive Values (NPV)

    The Negative Predictive Value (NPV) is the ratio of participants who are truly negative for MASLD divided by the number of participants who test negative for MASLD (true negatives and false negatives).

    Day 1 (day of liver ultrasound)

  • Area Under the Receiver Operating Curve (ROC)

    The area under the receiver operating characteristic curve is used to assess the diagnostic ability of Velacur and MRI in this specific cohort. The area under the ROC ranges from 0 to 1, where 0 indicates that all predictions were incorrect and 1 means that all predictions were correct.

    Day 1 (day of liver ultrasound)

  • Threshold of Detection Assessed by Youden Index

    Thresholds for Velacur to detect MASLD vs non-MASLD (using MRI as the gold standard) will be calculated using the Youden index, maximizing the difference between true positive rate and false positive rate. The Youden Index ranges from 0 to 1 where 1 indicates that there were no false positives or false negatives (the test is perfect) and 0 means that the test is not an effective way to predict the MASLD.

    Day 1 (day of liver ultrasound)

Study Arms (1)

Velacur Ultrasound

EXPERIMENTAL

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.

Diagnostic Test: VelacurDiagnostic Test: MRIDiagnostic Test: Blood sample collection for biomarkersDiagnostic Test: Liver biopsy

Interventions

VelacurDIAGNOSTIC_TEST

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.

Velacur Ultrasound
MRIDIAGNOSTIC_TEST

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.

Velacur Ultrasound
Liver biopsyDIAGNOSTIC_TEST

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.

Velacur Ultrasound
Blood sample collection for biomarkersDIAGNOSTIC_TEST

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.

Velacur Ultrasound

Eligibility Criteria

Age2 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Ascites
  • Pregnancy
  • Failure to give consent or assent
  • Have an implanted electronic device such as pacemaker, neurostimulator, or cochlear implant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Healthcare of Atlanta (CHOA)

Atlanta, Georgia, 30322, United States

Location

Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Miriam Vos, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2024

First Posted

January 23, 2024

Study Start

January 18, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

De-identified participant data will be available for sharing with other researchers including anthropometrics, demographics, laboratory results.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will become available for sharing after statistical analyses for the main study are complete.
Access Criteria
Researchers interested in using individual participant data from this study should contact the study PI at mvos@emory.edu with a proposal describing how the data will be used. Upon approval of the proposal the data will be sent via secure encrypted email.

Locations

US(2)