Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- E-Scopics
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- Correlation with MRI PDFF
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients with metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI-PDFF.
Detailed Description
The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI PDFF. The primary objective is to compare ultrasound parameters measurements of ultrasound attenuation, backscattering coefficient and sound speed to the hepatic fat fraction as measured with MRI-PDFF. The secondary objectives includes the comparison of measurements of quantitative ultrasound parameters between Hepatoscope and FibroScan, and to compare the measurement of liver stiffness between Hepatoscope and MRE. Exploratory objectives have been determined to allow the comparison of said measured parameters to the outcome of histopathological analysis in a subset patient population who would benefit from a liver biopsy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patient below 80 yo
- •Patients with MASLD/MASH recruited in interventional trials requiring MRI PDFF +/- MRE per interventional protocol, OR
- •Patients with MASLD/MASH recruited in prospective cohorts requiring MRI PDFF +/- MRE per interventional protocol, OR
- •Patients referred to MRI-PDFF or MRE.
- •Patients who consented in written to participate in the study
- •Patients with ongoing social security coverage
Exclusion Criteria
- •Patient in their minority (less than 18 yo) or older than 80 yo,
- •Patient with active implants,
- •Patient presenting with a wound where the Hepatoscope exam shall be performed (abdominal right upper quadrant)
- •Patient with a history of decompensated cirrhosis,
- •Patient with a history of hepatocellular carcinoma,
- •Adult patient under tutorship, or unable to express informed consent,
- •Pregnant or breast-feeding
- •Person deprived from their liberty
- •Patient hospitalized without providing consent or in case of an emergency
- •Patient presenting with another know liver disease
Outcomes
Primary Outcomes
Correlation with MRI PDFF
Time Frame: At a maximum of 6 months from enrollment
Spearman correlation coefficients between each Hepatoscope measurement (ATT, BSC and SOS) and MRI-PDFF measurements will be calculated. The confidence interval will be estimated with an alpha risk of 0,017 (Bonferroni adjustment, overal alpha risk of 0,05). Each correlation will be compared to the lowest acceptable threshold D = 0,50 with a Fisher Z test, with an alpha risk de 0,017.
Secondary Outcomes
- Comparison with Fibroscan CAP(At a maximum of 6 months from enrollment)