Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients
- Conditions
- Metabolic Syndrome XFatty LiverMASH - Metabolic Dysfunction-Associated SteatohepatitisMASLD
- Registration Number
- NCT06661655
- Lead Sponsor
- E-Scopics
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Correlation with MRI PDFF At a maximum of 6 months from enrollment Spearman correlation coefficients between each Hepatoscope measurement (ATT, BSC et SOS) and MRI-PDFF measurements will be calculated. The confidence interval will be estimated with an alpha risk of 0,017 (Bonferroni adjustment, overal alpha risk of 0,05). Each correlation will be compared to the lowest acceptable threshold D = 0,50 with a Fisher Z test, with an alpha risk de 0,017.
- Secondary Outcome Measures
Name Time Method Comparison with Fibroscan CAP At a maximum of 6 months from enrollment Spearman correlations between Hepatoscope measurements and MRI-PDFF will be compared to Spearman correlations between Fibroscan CAP measurements and MRI-PDFF. The 95% confidence interval of each correlation will be estimated and compared to each other using a Fisher Z test with an alpha risk of 0,05.
Trial Locations
- Locations (3)
University Hospital Angers
🇫🇷Angers, France
Beaujon University Hospital
🇫🇷Clichy, France
Pitie Salpetriere University Hospital
🇫🇷Paris, France