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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3/ Discordance analysis using independent clinical criteria (e.g. biopsy, other circulating or imaging NITs,) | 6 months |
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Inclusion Criteria:
SLD with MASLD or MetALD Adult patients with:
Other imaging modality reports ie. MRI, ARFI, ct1, SWE and Fibroscan can be included when available
Exclusion Criteria:
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• 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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Garth George, MD | Contact | 352-638-3982 | spicedoc@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Gastroenterology & Surgery Associates | Lady Lake | Florida | 32159 | United States |
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| Related Info | View source |
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