Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients
E-Scopics
120 participants
Jul 24, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria10
- 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
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Interventions
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)
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NCT06661655