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Recruiting NCT06661655

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

No phase Interventional Metabolic Syndrome X Fatty Liver MASH - Metabolic Dysfunction-Associated Steatohepatitis MASLD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Liver ultrasound.
Who it may be relevant to
Registry conditions: Metabolic Syndrome X, Fatty Liver, MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASLD. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Correlation with MRI PDFF [Time frame: At a maximum of 6 months from enrollment]
Secondary outcome measures (1)
  • Comparison with Fibroscan CAP [Time frame: At a maximum of 6 months from enrollment]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 3 centers
  • University Hospital Angers — Angers
  • Beaujon University Hospital — Clichy
  • Pitie Salpetriere University Hospital — Paris

Identifiers

NCT: NCT06661655 · ES213 · 2023-A02456-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗