Ultraportable Hepatoscope ultrasound for measuring liver fat in MASLD/MASH
Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients
The Hepatoscope device will be tested to see if it can measure liver fat accurately in adults with MASLD/MASH compared with MRI-PDFF.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | E-Scopics Industry-sponsored |
| Locations | 3 sites (Angers and 2 other locations) |
| Trial ID | NCT06661655 on ClinicalTrials.gov |
What this trial studies
The trial compares quantitative ultrasound measures from an ultraportable device (Hepatoscope)—including attenuation, backscattering coefficient, and sound speed—against hepatic fat fraction measured by MRI-PDFF in adults with metabolic-dysfunction associated liver disease. Secondary analyses will compare Hepatoscope parameters with FibroScan results and Hepatoscope-derived stiffness with MRE-derived stiffness. An exploratory substudy will compare imaging results to histopathology in a subset of participants who undergo liver biopsy. Participants are adults under 80 recruited at three French university hospitals and will receive the Hepatoscope exam alongside clinically indicated MRI-PDFF +/- MRE.
Who should consider this trial
Good fit: Adults aged 18–79 with MASLD/MASH who can give written consent and who are scheduled for or referred to MRI-PDFF +/- MRE (or enrolled in relevant cohorts or interventional protocols) are ideal candidates.
Not a fit: Patients under 18 or over 80, those with active implants, decompensated cirrhosis, hepatocellular carcinoma, wounds at the examination site, pregnancy or breastfeeding, inability to consent, or those deprived of liberty are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, Hepatoscope could offer a quicker, portable, non-invasive and more accessible way to monitor liver fat without needing MRI for every patient.
How similar studies have performed: Other quantitative ultrasound methods and elastography techniques (for example FibroScan/CAP and MRE) have shown good correlations with liver fat and stiffness, but the specific ultraportable Hepatoscope device is novel and less extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Angers and 2 other locations
- University Hospital Angers — Angers, France (Recruiting)
- Beaujon University Hospital — Clichy, France (Recruiting)
- Pitie Salpetriere University Hospital — Paris, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Jerome Boursier, MD, PhD
- Email: jeboursier@chu-angers.fr
- Phone: +33 2 41 35 31 42
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.