NCT06797596Not yet recruiting
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.
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.
Source: ClinicalTrials.gov · Last updated 13 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 23 Jan 2025
- Start date
- May 2025
- Primary completion date
- 15 Jul 2025
- Lead sponsor
- Fibronostics USA, Inc
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06797596
What you commit to
- Study type: Observational
- Planned participants: 100
- From May 2025 to the primary completion date, 15 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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
- Other comorbidities not compatible with the diagnosis of MASLD or MetALD
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Advanced Gastroenterology & Surgery Associates Coordinator of this site? Confirm its status | Lady Lake | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.