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.

Part of paid clinical trials in Lady Lake, Florida.

Sponsor
Fibronostics USA, Inc
Study ID
NCT06797596
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
May 31, 2025
Status verified
Jan 2025
Primary completion
Jul 15, 2025
Completion
Aug 30, 2025

Study Design

Enrollment
100 participants (estimated)

Primary Outcome Measure

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. [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Advanced Gastroenterology & Surgery AssociatesLady LakeFlorida32159-

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Advanced Gastroenterology & Surgery Associates· Lady Lake, FL

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