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.

NCT06797596 | Not Yet Recruiting

• 1 other identifier: FIBRO-LFASt-MRE-009-2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (2)

• 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)

  6 months

• 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.

  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

  6 months

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

• The expected number of subjects is around N=100 adult patients with Steatotic Liver Disease (MASLD or MetALD) with either paired MRE historical report and LIVERFASt or MR and LIVERFASt.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fibronostics USA, Inc: lead

Study Sites (1)

Advanced Gastroenterology & Surgery Associates

Lady Lake, Florida, 32159, United States

Location

Related Links

• Related Info

Central Study Contacts

Garth George, MD

CONTACT

352-638-3982; spicedoc@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 28, 2025
• Study Start: May 1, 2025
• Primary Completion: July 15, 2025
• Study Completion: August 30, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-01

Locations

US (1)