Actively Recruiting
Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients
Led by E-Scopics · Updated on 2025-08-15
120
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an ultraportable ultrasound device called Hepatoscope for non-invasive assessment of liver fat (hepatic steatosis) in patients with metabolic dysfunction-associated liver diseases (MASLD and MASH). The study compares Hepatoscope's measurements to current diagnostic methods like MRI-PDFF, aiming to assess how well the device measures liver fat and stiffness. This research is sponsored by E-Scopics and focuses on patients with fatty liver conditions related to metabolic syndrome. Participants will undergo an ultrasound exam using the Hepatoscope device to collect quantitative data related to liver steatosis severity. The device measures ultrasound attenuation, backscattering coefficient, and sound speed. The study compares these ultrasound parameters to liver fat fraction measured by MRI-PDFF and also evaluates comparisons with FibroScan and magnetic resonance elastography (MRE) for liver stiffness. Some patients may also have liver biopsy results for further comparison. During the study, participants will receive the Hepatoscope ultrasound exam and have their measurements compared with MRI-PDFF within six months of enrollment. Other evaluations include FibroScan and MRE comparisons. The study involves written consent, ongoing social security coverage, and monitoring for safety and accuracy. The total participation timeline and follow-up procedures align with the imaging and clinical assessments conducted within this period.
CONDITIONS
Brief Title
Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient below 80 years old
- Patients with MASLD or MASH recruited in interventional trials requiring MRI PDFF +/- MRE per protocol
- Patients with MASLD or MASH recruited in prospective cohorts requiring MRI PDFF +/- MRE per protocol
- Patients referred to MRI-PDFF or MRE
- Patients who have given written consent to participate
- Patients with ongoing social security coverage
You will not qualify if you...
- Patients younger than 18 years or older than 80 years
- Patients with active implants
- Patients with wounds in the right upper quadrant of the abdomen where the Hepatoscope exam is performed
- Patients with a history of decompensated cirrhosis
- Patients with a history of hepatocellular carcinoma
- Adults under tutorship or unable to provide informed consent
- Pregnant or breastfeeding patients
- Persons deprived of liberty
- Patients hospitalized without consent or in an emergency
- Patients with another known liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months from enrollment
Participants undergo ultrasound exams with the Hepatoscope device to collect quantitative measurements related to liver steatosis. These measurements are compared with MRI PDFF, FibroScan, and MRE results as part of the diagnostic assessment.
1 to 2 visits depending on imaging schedules
Trial Site Locations
Total: 3 locations
1
University Hospital Angers
Angers, France, 49933
Actively Recruiting
2
Beaujon University Hospital
Clichy, France, 92110
Actively Recruiting
3
Pitie Salpetriere University Hospital
Paris, France, 75013
Not Yet Recruiting
Research Team
J
Jerome Boursier, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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