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.
Starting soon
Conditions studied: Liver Fibrosis Due to NASH, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Alcohol Liver Disease
In brief
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 facts
- Study ID
- NCT06797596
- Run by
- Fibronostics USA, Inc
- People needed
- 100
- Starts
- 2025-05-01
- Expected to finish
- 2025-08-30
- Last updated by the study team
- 2025-03-13
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Advanced Gastroenterology & Surgery Associates — Lady Lake, Florida, United States
Full record on ClinicalTrials.gov
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