Steatosis of Liver Clinical Trial
— FAT-PLUSOfficial title:
Comparison of the Ultrasound Index Fat Fraction (FAT PLUS) With the MRI-PDFF Score for Quantification of Hepatic Steatosis.
| Verified date | April 2024 |
| Source | SuperSonic Imagine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | September 2024 |
| Est. primary completion date | July 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| SuperSonic Imagine |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | FAT PLUS | 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. | 3 months |
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