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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 willing to sign a consent form, - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Liver ultrasound

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.

Locations (3)

University Hospital Angers
Angers, France
Beaujon University Hospital
Clichy, France
Pitie Salpetriere University Hospital
Paris, France