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NCT05908006

Validation Study of the Velacur System in Comparison to MRE & MRI-PDFF in Patients With (Suspected) Liver Disease

Status unknown Last updated 18 June 2023
What this trial tests

trial testing Velacur in Non-alcoholic Fatty Liver Disease (NAFLD) in 100 participants. Status unknown.

Timeline
15 July 2023
Primary endpoint
30 December 2023
31 January 2024

Quick facts

Lead sponsorGI Alliance
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment100
Start date15 July 2023
Primary completion30 December 2023
Estimated completion31 January 2024
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

GI Alliance

Who can join

Adults 18 to 80, any sex, with Non-alcoholic Fatty Liver Disease (NAFLD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Validation of Velacur Liver Stiffness and Attenuation in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease.
    Surapaneni SN, Hogan R, Mury T, Horton A, et al · · 2026 · PMID 42205166 · DOI 10.1016/j.gastha.2026.100952

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05908006.

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