Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients
NCT ID: NCT06661655
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-07-24
2026-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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E-Scopics
INDUSTRY
Responsible Party
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Principal Investigators
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Claude Cohen-Bacrie
Role: STUDY_DIRECTOR
E-Scopics
Jerome Boursier, MD, PhD
Role: STUDY_CHAIR
University Hospital, Angers
Locations
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University Hospital Angers
Angers, , France
Beaujon University Hospital
Clichy, , France
Pitie Salpetriere University Hospital
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-A02456-39
Identifier Type: OTHER
Identifier Source: secondary_id
ES213
Identifier Type: -
Identifier Source: org_study_id
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