Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients

E-Scopics120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

120

Conditions

Metabolic Syndrome X Fatty Liver

Interventions

Liver ultrasoundDEVICE

Hepatoscope is a point of care ultraportable ultrasound device that is capable of conventional grayscale ultrasound imaging, of 2D transient elastography (imaging + liver stiffness measurement), and of quantitative ultrasound properties measurement (ultrasound attenuation, backscattering coefficient, sound speed) related to liver steatosis.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

University Hospital Angers

Angers, France

RECRUITING

Beaujon University Hospital

Clichy, France

RECRUITING

Pitie Salpetriere University Hospital

Paris, France

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Correlation with MRI PDFF

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.

Time frame: At a maximum of 6 months from enrollment

Secondary Outcomes

Comparison with Fibroscan CAP

Spearman correlations between Hepatoscope measurements and MRI-PDFF will be compared to Spearman correlations between Fibroscan CAP measurements and MRI-PDFF. The 95% confidence interval of each correlation will be estimated and compared to each other using a Fisher Z test with an alpha risk of 0,05.