NCT05908006

Brief Summary

The goal of this open-label, non-randomized, prospective study is to compare Velacur and MRE in all sexes, 18-80 years old with Non-Alcoholic Fatty Liver Disease (NAFLD). The main aims is to:

  • Validate the use of Velacur and elastography cut offs in a patient cohort with all types of chronic liver disease, against MRE results for fibrosis staging.
  • Validate the use of Velacur and attenuation cut offs in a patient cohort with all types of chronic liver disease, against MRI-PDFF results for steatosis staging. Participants will Study participants will attend 1 study visit, in which measurement of liver stiffness with Velacur and FibroScan, will be performed by a certified technician. As part of Visit 1, Patients will also complete an MRI exam which will include both MRE and MRI-PDFF measurements (MRI imaging can take place within 28 days of the Velacur scan).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

March 29, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

March 29, 2023

Last Update Submit

June 14, 2023

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)

Keywords

NASHNAFL

Outcome Measures

Primary Outcomes (2)

  • Elasticity measurements

    Validate the use of Velacur and elastography cut offs with all types of chronic liver disease, against MRE results for fibrosis staging. The liver tissue elasticity is measured in kilopascals (kPa), using Velacur. The Velacur elasticity measurements will be compared to those from Magnetic Resonance Elastography, which is measuring liver tissue elasticity in kilopascals (kPa).

    2024

  • Attenuation measurement

    Validate the use of Velacur and attenuation cut offs with all types of chronic liver disease, against MRI-PDFF results for steatosis staging. Ultrasound attenuation is a quantitative measurement of ultrasound image parameters. Attenuation is measured by Velacur, and uses units of of decibels per meter (dB/m). These numbers are compared to the fat percentage as measured by MRI proton density fat fraction, which is measured in percentage fat (%).

    2024

Secondary Outcomes (2)

  • Serum markers such as Fib-4, APRI and NALFD Fibrosis score or ELF (enhanced liver fibrosis) score.

    2024

  • The combined outputs of elasticity and attenuation from Velacur and FibroScan

    2024

Other Outcomes (2)

  • Elasticity and attenuation measurements from the Velacur system and BMI measurements (kg/m2)

    2024

  • Comparison of previously calculated cutoff, with new measurements.

    2024

Study Arms (1)

non-randomized, open-label study

All participants will have the same Laboratory and Diagnostic Assessments and Imaging Procedures.

Device: Velacur

Interventions

VelacurDEVICE

Imaging Procedures Comparison

Also known as: MRE/MRI, Fibroscan
non-randomized, open-label study

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All sexes, 18-80 years old. Patients with Non-Alcoholic Fatty Liver Disease (NAFLD), including both those with Non-Alcoholic Fatty Liver (NAFL) and Non-Alcoholic Steatohepatitis (NASH).

You may qualify if:

  • Patients with evidence of NAFLD or other chronic liver disease such as one of the following:
  • Biopsy proven chronic liver disease OR
  • Evidence of hepatic steatosis or chronic liver disease on non-invasive assessment by one or more of the following criteria:
  • Abdominal ultrasound within 12 months
  • MRI-PDFF (greater than 12%) within 12 months
  • FibroScan CAP score \> 230 dB/m within 12 months OR At least 2 criteria for metabolic syndrome and increased stiffness on FibroScan (\>8kPa) within 12 months

You may not qualify if:

  • BMI greater than 40 kg/m2 (or unable to fit into MRI bore)
  • Subject with current, significant alcohol consumption or history of significant alcohol consumption
  • Subjects with evidence of decompensated liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GI Alliance-Flowood, MS

Flowood, Mississippi, 39232, United States

Location

GI Alliance-Webster, TX

Webster, Texas, 77598, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Sri Naveen Surapaneni, MD

    GI Alliance

    PRINCIPAL INVESTIGATOR

  • Reed B Hogan, III, MD

    GI Alliance

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jo Ann Gilbert

CONTACT

972-637-8546JoAnn.Gilbert@GIAlliance.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2023

First Posted

June 18, 2023

Study Start

July 15, 2023

Primary Completion

December 30, 2023

Study Completion

January 31, 2024

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations

US(2)