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.

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

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-90

SponsorFibronostics USA, Inc

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Sponsors and collaborators

Fibronostics USA, Inc

Lead sponsor

Source ClinicalTrials.gov