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.

N/ANot Yet RecruitingNCT06797596

Fibronostics USA, Inc100 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Liver Fibrosis Due to NASH MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Alcohol Liver Disease

Eligibility

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

1/ Two-class concordance rate (kappa, p value) between MRE and LIVERFASt fibrosis test for each of the fibrosis endpoints (≥F2, ≥F3, F4)

Time frame: 6 months

2/ AUROCs (95%CI) for fibrosis endpoints (≥F2, ≥F3, F4) and steatosis endpoints (≥S1, ≥S2 and S3) against surrogate gold-standard, MRE and MR-PDFF, respectively

Time frame: 6 months

Secondary Outcomes

3/ Discordance analysis using independent clinical criteria (e.g. biopsy, other circulating or imaging NITs,)

Time frame: 6 months

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.

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts