Steatosis of Liver
Conditions
Brief summary
The objective is to compare the ultrasound index fat fraction (FAT PLUS), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (MRI-PDFF) in patients to quantify the hepatic steatosis.
Interventions
DEVICEEchographic scan
Liver ultrasound exam
Sponsors
SuperSonic Imagine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is ≥ 18 years old. * Subject is able to understand and sign the Informed Consent Form. * Subject is able to stand and walk independently. * Subject must have at least one or more routine ultrasound imaging procedures of the abdomen, at one of the participating study sites. * Subject must have at least one routine liver MRI with PDFF score performed within 30 days before or after the ultrasound examination * Subject is affiliated to National Social Insurance or a Health Insurance Regimen
Exclusion criteria
* Subject is unable or unwilling to adhere to Study procedures * Subject is unable to understand the Informed Consent * Subject is unable to express its consent * Subject is under legal protection * Subject is deprived of liberty by judicial or administrative decision * Subject undergoes psychiatric treatment under constraint * Subject is pregnant or breastfeeding * Subject has latex allergy * Subject has an open wound, cut, and/or a rash which would preclude an ultrasound imaging procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FAT PLUS | 3 months | The objective is to compare the ultrasound index fat fraction (FAT PLUS), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (MRI-PDFF) in patients to quantify the hepatic steatosis. |
Countries
France
Outcome results
None listed