Trials / Not Yet Recruiting
Not Yet RecruitingNCT06797596
Clinical Correlation Evaluation of the LIVERFASt Test for Diagnosing Important Liver Lesions of Fibrosis and Steatosis Against Magnetic Resonance Elastography (MRE) for Liver Fibrosis and MR-based Assessment of Steatosis, in Adult US Population.
Clinical Correlation Evaluation of the LIVERFAStTM Test for Diagnosing Important Liver Lesions of Fibrosis and Steatosis Against MR-based Liver Assessment, Magnetic Resonance Elastography (MRE) for Liver Fibrosis and MR-based Assessment of Steatosis, in Adult US Population.
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Fibronostics USA, Inc · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- —
Summary
This is a retrospective cross-sectional research intended to explore the utility of LIVERFASt in the clinical pathways for the detection of liver fibrosis and steatosis in comparison with the Magnetic Resonance Elastography (MRE) and MRct1 fibrosis classification (historical records) and to assess LIVERFASt performance for MR steatosis assessment in an United States adult miscellaneous population with available (historical) MR intracellular fat fraction assessment (ICFF) from a single tertiary US clinic.
Detailed description
1. To assess the correlation and the strength of concordance of LIVERFASt for staging important liver lesions of fibrosis and steatosis against MR liver assessment of clinically significant (≥F2 stage), advanced fibrosis (≥F3 stage) and cirrhosis (F4 stage) (MRE, ct1) and steatosis (MR) in a SLD (MASLD, MetALD) adult US population. 2. To assess the diagnostic performance \[AUROC (95%CI)\] of LIVERFASt for diagnosing important liver lesions of fibrosis, steatosis taking MR-based methods as surrogate gold-standard (MRE for fibrosis assessment and MR for steatosis quantification).
Conditions
- Liver Fibrosis Due to NASH
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- Alcohol Liver Disease
Timeline
- Start date
- 2025-05-01
- Primary completion
- 2025-07-15
- Completion
- 2025-08-30
- First posted
- 2025-01-28
- Last updated
- 2025-03-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06797596. Inclusion in this directory is not an endorsement.