Not Yet RecruitingNot Applicable

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.

United States100 participantsStarted 2025-05

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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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

What they're measuring

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.

Timeframe: 6 months

Trial details

NCT IDNCT06797596

SponsorFibronostics USA, Inc

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-15

Contact for this trial

Garth George, MD

352-638-3982 spicedoc@gmail.com

View on ClinicalTrials.gov More Liver Fibrosis Due to NASH trials