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Evaluating LIVERFASt Test for Liver Fibrosis and Steatosis

This study is looking at how well a test called LIVERFASt compares to other methods for finding important liver problems like fibrosis (scarring) and steatosis (fatty liver). Researchers want to see if LIVERFASt can accurately detect these conditions in adults in the US who have liver disease due to metabolic issues (MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease) or alcohol (Alcohol Liver Disease). They are comparing LIVERFASt results with information from Magnetic Resonance Elastography (MRE) for fibrosis and MR-based assessments for steatosis, using historical patient records. The goal is to understand if LIVERFASt can be a useful tool in identifying these liver conditions. This study is currently unclear on its recruitment status.

Study design
This is an observational study planning to include 100 adult participants. It is a retrospective cross-sectional study, meaning it looks at existing data from a single point in time.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 6 months, which suggests a follow-up period for data collection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06797596

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.

Not Yet Recruiting
Not specifiedAges 18–90Observational
Fibronostics USA, Inc
~100 participants
Updated 2025-03-13 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
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.
Measured over 6 months
+1 more outcome measured

Conditions

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

Explore related trials

Alcoholic Liver DiseaseLiver FibrosisNonalcoholic Fatty Liver Disease

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Garth George, MD
[email protected]
352-638-3982
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 this trial measures

  • 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

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

  • 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

    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