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

NCT06661655 | Recruiting

• 2 other identifiers: ES2132023-A02456-39
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Keywords

Liver; Fibrosis; Steatosis; Elastography; Ultrasound; Attenuation; Backscattering coefficient; Sound speed; MRI PDFF; Hepatoscope

Outcome Measures

Primary Outcomes (1)

• Correlation with MRI PDFF

  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.

  At a maximum of 6 months from enrollment

Secondary Outcomes (1)

• Comparison with Fibroscan CAP

  At a maximum of 6 months from enrollment

Study Arms (1)

Main cohort

EXPERIMENTAL

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

Device: Liver ultrasound

Interventions

Liver ultrasound DEVICE

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.

Main cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• E-Scopics: lead

Study Sites (3)

University Hospital Angers

Angers, 49933, France

RECRUITING

Beaujon University Hospital

Clichy, 92110, France

RECRUITING

Pitie Salpetriere University Hospital

Paris, 75013, France

NOT YET RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Fatty Liver; Non-alcoholic Fatty Liver Disease; Fibrosis

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claude Cohen-Bacrie

  E-Scopics

  STUDY DIRECTOR

• Jerome Boursier, MD, PhD

  University Hospital, Angers

  STUDY CHAIR

Central Study Contacts

Jerome Boursier, MD, PhD

CONTACT

+33 2 41 35 31 42; jeboursier@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cross sectional investigation

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: July 24, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

FR (3)