Alcohol Liver Disease, Liver Fibrosis Due to NASH, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Conditions
Keywords
LIVERFASt, LIVERFASt Test, Noninvasive Test for the Liver, LIVERFASt for MASLD, LIVERFASt for MASH, Fibronostics, Liverfast fibrosis test, Liverfast steatosis test, Liverfast for MASLD and MASH, Liverfast for liver fibrosis, Liverfast plus MRE, Liverfast and MRE, Liverfast and other imaging tools
Brief 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).
Interventions
None listed
Sponsors
Fibronostics USA, Inc
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Inclusion criteria
* SLD with MASLD or MetALD Adult patients with: * available historical report of MRE and LIVERFASt test * at least fibrosis scoring available (steatosis and necro-inflammation imaging reports are requested equally when available). * Other imaging modality reports ie. MRI, ARFI, ct1, SWE and Fibroscan can be included when available
Exclusion criteria
* Participants identified as having risk factors for false positive/negative results for Liverfast (severe intravascular hemolysis-if condition is known-, acute hepatitis or severe cytolysis with ≥ 600 ALT values) * Other comorbidities not compatible with the diagnosis of MASLD or MetALD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical correlation evaluation of the LIVERFAStTM Test for diagnosing important liver lesions of fibrosis and steatosis against Magnetic Resonance Elastography for Liver Fibrosis and MR-based assessment of steatosis, in adult US population. | 6 months | 1/ Two-class concordance rate (kappa, p value) between MRE and LIVERFASt fibrosis test for each of the fibrosis endpoints (≥F2, ≥F3, F4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical correlation evaluation of the LIVERFAStTM Test for diagnosing important liver lesions of fibrosis and steatosis against Magnetic Resonance Elastography for Liver Fibrosis and MR-based assessment of steatosis, in adult US population. | 6 months | 3/ Discordance analysis using independent clinical criteria (e.g. biopsy, other circulating or imaging NITs,) |
Countries
United States
Contacts
Primary ContactGarth George, MD
Outcome results
None listed