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.

Launched by FIBRONOSTICS USA, INC · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new test called LIVERFASt, which helps doctors identify liver problems like fibrosis (scarring) and steatosis (fatty liver) in patients. The study will compare how well LIVERFASt works against a current imaging method called Magnetic Resonance Elastography (MRE) in finding these liver issues. The trial will involve adults in the United States who have a history of liver conditions related to metabolic disorders, alcohol use, or non-alcoholic fatty liver disease.

To be eligible, participants should have had previous tests done that include both MRE and LIVERFASt, along with fibrosis scoring reports. The trial will not accept individuals with certain serious liver conditions or other health issues that could affect the accuracy of the test results. While the trial is not yet recruiting, those who participate can expect to contribute to important research that could improve how liver diseases are diagnosed and treated in the future.

Gender

ALL

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