Ultraportable Hepatoscope ultrasound for measuring liver fat in MASLD/MASH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares quantitative ultrasound measures from an ultraportable device (Hepatoscope)—including attenuation, backscattering coefficient, and sound speed—against hepatic fat fraction measured by MRI-PDFF in adults with metabolic-dysfunction associated liver disease. Secondary analyses will compare Hepatoscope parameters with FibroScan results and Hepatoscope-derived stiffness with MRE-derived stiffness. An exploratory substudy will compare imaging results to histopathology in a subset of participants who undergo liver biopsy. Participants are adults under 80 recruited at three French university hospitals and will receive the Hepatoscope exam alongside clinically indicated MRI-PDFF +/- MRE.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital Angers
  Angers, France Recruiting
• Beaujon University Hospital
  Clichy, France Recruiting
• Pitie Salpetriere University Hospital
  Paris, France Not yet recruiting

Study contacts

• Study coordinator: Jerome Boursier, MD, PhD
• Email: jeboursier@chu-angers.fr
• Phone: +33 2 41 35 31 42

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.