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NCT05908006
Validation Study of the Velacur System in Comparison to MRE & MRI-PDFF in Patients With (Suspected) Liver Disease
trial testing Velacur in Non-alcoholic Fatty Liver Disease (NAFLD) in 100 participants. Status unknown.
30 December 2023
Quick facts
| Lead sponsor | GI Alliance |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 15 July 2023 |
| Primary completion | 30 December 2023 |
| Estimated completion | 31 January 2024 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Velacur
Conditions studied
- Non-alcoholic Fatty Liver Disease (NAFLD) — all drugs for Non-alcoholic Fatty Liver Disease (NAFLD) →
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):
-
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
Verify or expand the search:
- PubMed search for NCT05908006
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT05699018 — Screening in Primary Care of Advanced Liver Fibrosis in NAFLD And/or Alcoholic Patients · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05908006 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GI Alliance
- Last refreshed: 18 June 2023
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing