Clinical trial 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.
Official title: Clinical Correlation Evaluation of the LIVERFAStTM Test for Diagnosing Important Liver Lesions of Fibrosis and Steatosis Against MR-based Liver Assessment, Magnetic Resonance Elastography (MRE) for Liver Fibrosis and MR-based Assessment of Steatosis, in Adult US Population.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Fibronostics USA, Inc
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: 1. To assess the correlation and the strength of concordance of LIVERFASt for staging important liver lesions of fibrosis and steatosis against MR liver assessment of clinically significant (≥F2 stage), advanced fibrosis (≥F3 stage) and cirrhosis (F4 stage) (MRE, ct1) and steatosis (MR) in a SLD (MASLD, MetALD) adult US population.
2. To assess the diagnostic performance \[AUROC (95%CI)\] of LIVERFASt for diagnosing important liver lesions of fibrosis, steatosis taking MR-based methods as surrogate gold-standard (MRE for fibrosis assessment and MR for steatosis quantification).

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 6 months
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.
timeFrame: 6 months
Secondary outcomes:
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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Lady Lake
country: United States
facility: Advanced Gastroenterology & Surgery Associates
state: Florida
Study officials:
References: