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

E-Scopics

Status: Enrolling

Conditions: Fatty Liver; NASH (Non-Alcoholic Steatohepatitis); Steatosis, Liver; MASLD; NAFLD; Metabolic Syndrome X; MASH - Metabolic Dysfunction-Associated Steatohepatitis

Treatments: Device: Liver ultrasound

Study type: Interventional

Funder types: Industry

Identifiers

NCT06661655

2023-A02456-39 (Other Identifier)

ES213

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Main cohort

Experimental group

Description:

Patients recruited in the study will receive an ultrasound exam with Hepatoscope to collect quantitative measurements related to the severity of liver steatosis.

Treatment:

Device: Liver ultrasound