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Clinical Trials in France / NCT06661655
Recruiting Not applicable

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

NCT06661655 · tracked via the Priya Life Science France tracker
Sponsor
E-Scopics
Phase
Not applicable
Started
2025-07-24
Last updated
2025-08-15

Condition(s) studied

Metabolic Syndrome XFatty LiverMASH - Metabolic Dysfunction-Associated SteatohepatitisMASLDNASH (Non-Alcoholic Steatohepatitis)Steatosis, LiverNAFLD

Investigational drug(s) / intervention(s)

Liver ultrasound

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Correlation with MRI PDFF — At a maximum of 6 months from enrollment
    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.

Trial sites (3)

FacilityCityRegionStatus
University Hospital Angers Angers France Recruiting
Beaujon University Hospital Clichy France Recruiting
Pitie Salpetriere University Hospital Paris France Not Yet Recruiting

Other trials for the same condition

Comparison of Two sTRAtegies For the Non-Invasive Diagnosis of advanCed Liver Fibrosis in NAFLD Recruiting
Global Research Initiative for Patients Screening on MASH Recruiting
The European NAFLD Registry Recruiting
LITMUS Imaging Study Active, not recruiting
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06661655 on ClinicalTrials.gov ↗ ← All trials in France