Ultrasound Index Fat Fraction

Not Applicable

Not yet recruiting

• Conditions: Steatosis of Liver
• Interventions: Device: Echographic scan

• Registration Number: NCT06373796
• Lead Sponsor: SuperSonic Imagine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Study First Posted: 2024-04-18
• Last Update Posted: 2024-04-18
• Study Start: 2024-05
• Primary Completion: 2024-07
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FAT PLUS	Echographic scan	-

Primary Outcome Measures

Name	Time	Method
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.