Ultrasound Index Fat Fraction

Steatosis of Liver Clinical Trial

— FAT-PLUS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06373796
• Other study ID #: 2024-A00523-44
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: SuperSonic Imagine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fatty Liver
• Steatosis of Liver

Intervention

Device:
• Echographic scan
Liver ultrasound exam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SuperSonic Imagine

Outcome

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