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

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.

Study Overview

• Status: Recruiting
• Conditions: Fatty Liver; NAFLD; Metabolic Syndrome X; Steatosis, Liver; NASH (Non-Alcoholic Steatohepatitis); MASLD; MASH - Metabolic Dysfunction-Associated Steatohepatitis
• Intervention / Treatment: Device: Liver ultrasound

Detailed Description

The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI PDFF.

The primary objective is to compare ultrasound parameters measurements of ultrasound attenuation, backscattering coefficient and sound speed to the hepatic fat fraction as measured with MRI-PDFF.

The secondary objectives includes the comparison of measurements of quantitative ultrasound parameters between Hepatoscope and FibroScan, and to compare the measurement of liver stiffness between Hepatoscope and MRE.

Exploratory objectives have been determined to allow the comparison of said measured parameters to the outcome of histopathological analysis in a subset patient population who would benefit from a liver biopsy.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• France
  • Angers, France, 49933
    • Recruiting
    • University Hospital Angers
    • Contact: Jerome Boursier, MD, PhD; Phone Number: +33 2 41 35 31 42; Email: jeboursier@chu-angers.fr
    • Principal Investigator: Jerome Boursier, MD PhD
    • Sub-Investigator: Christophe Aubé, MD, PhD
  • Clichy, France, 92110
    • Recruiting
    • Beaujon University Hospital
    • Contact: Laurent Castera, MD, PhD; Phone Number: +33 1 40 87 55 24; Email: laurent.castera@aphp.fr
    • Principal Investigator: Laurent Castera, MD, PhD
    • Sub-Investigator: Valerie Vilgrain, MD, PhD
    • Sub-Investigator: Marco Dioguardi Burgio, MD
    • Sub-Investigator: Hélène Fontaine, MD
  • Paris, France, 75013
    • Not yet recruiting
    • Pitie Salpetriere University Hospital
    • Contact: Raluca Pais, MD; Phone Number: +33 1 42 16 10 34; Email: raluca.pais@aphp.fr
    • Principal Investigator: Raluca Pais, MD
    • Sub-Investigator: Olivier Lucidarme, MD, PhD
    • Sub-Investigator: Mathilde Wagner, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Main cohort; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison with Fibroscan CAP	Spearman correlations between Hepatoscope measurements and MRI-PDFF will be compared to Spearman correlations between Fibroscan CAP measurements and MRI-PDFF. The 95% confidence interval of each correlation will be estimated and compared to each other using a Fisher Z test with an alpha risk of 0,05.	At a maximum of 6 months from enrollment

Collaborators and Investigators

• Sponsor: E-Scopics
• Investigators: Study Director: Claude Cohen-Bacrie, E-Scopics; Study Chair: Jerome Boursier, MD, PhD, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Ultrasound; Fibrosis; Steatosis; Elastography; Liver; MRI PDFF; Attenuation; Sound speed; Backscattering coefficient; Hepatoscope
• Additional Relevant MeSH Terms: Metabolic Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Liver Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: ES213; 2023-A02456-39 (Other Identifier: French ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only de-identified individual participant data may be shared, limited to data collected in CRF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No