Ultrasound Index Fat Fraction

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.

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Key information

Conditions

Steatosis of Liver Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers

Angers, 49000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echographic scan

Device

Liver ultrasound exam

Primary outcomes

FAT PLUS

Time frame: 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.

Sponsors and collaborators

Lead sponsor

SuperSonic Imagine

Industry

Registry information

Official study title

Comparison of the Ultrasound Index Fat Fraction (FAT PLUS) With the MRI-PDFF Score for Quantification of Hepatic Steatosis.

Acronym: FAT-PLUS

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Apr 18, 2024
Registry last updated: Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed