Clinical trial NCT06661655: Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients
Official title: Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome X
Fatty Liver
MASH - Metabolic Dysfunction-Associated Steatohepatitis
MASLD
Keywords: Liver
Fibrosis
Steatosis
Elastography
Ultrasound
Attenuation
Backscattering coefficient
Sound speed
MRI PDFF
Lead sponsor: E-Scopics
Sponsor class: INDUSTRY
First posted: 2024-10-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cross sectional investigation
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to evaluate a new ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients presenting with steatopathy from metabolic origin, by comparing its measurements with current diagnostic modalities, such as MRI PDFF.

Detailed description: The objective of the study is to evaluate a new ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients presenting with steatopathy from metabolic origin, 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 also include the comparison of measurements of liver stiffness as an indicator of liver fibrosis risk in patients at risk of having MASH.

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.

Eligibility criteria: 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 exman 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 outcomes:
measure: Correlation with MRI PDFF
timeFrame: At a maximum of 6 months from enrollment
Secondary outcomes:
measure: Comparison with Fibroscan CAP
timeFrame: At a maximum of 6 months from enrollment
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital Angers
city: Clichy
country: France
facility: Beaujon University Hospital
city: Paris
country: France
facility: Pitie Salpetriere University Hospital
Study officials:
affiliation: E-Scopics
name: Claude Cohen-Bacrie
role: STUDY_DIRECTOR
affiliation: University Hospital, Angers
name: Jerome Boursier, MD, PhD
role: STUDY_CHAIR
References: