Assessment of Fatty Liver with Thermo-acoustic Device

Recruiting

• Conditions: NAFLD; Non-alcoholic Steatohepatitis; Fatty Liver Disease; NASH; Non-alcoholic Fatty Liver; Non-Alcoholic Fatty Liver Disease; Fatty Liver
• Interventions: Diagnostic Test: Thermo-acuostic image acquisition of liver; Diagnostic Test: MRI-PDFF estimation of hepatic fat

• Registration Number: NCT04302051
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

The study will evaluate the accuracy of hepatic steatosis estimation by thermo-acoustic ultrasound with estimation by MRI-PDFF (Proton Density Fat Fraction) . It will also evaluate the sensitivity of this device in the diagnosis of fatty liver.

Detailed Description

Patients with either known or presumed diagnosis of non-alcoholic fatty liver disease who meets eligibility criteria will be included in the study. They will have imaging done to estimate hepatic steatosis by two modalities (MRI - PDFF and thermo-acoustic ultrasound). The estimation obtained by thermo-acoustic ultrasound will be compared with MRI results for accuracy of estimation by the thermo-acoustic ultrasound device. The study will also evaluate the sensitivity of the thermo-acoustic ultrasound device if it can diagnose the presence of hepatic steatosis when hepatic fat content is 15% or less by volume.

Study Timeline

• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-10
• Study Start: 2023-11-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• patients diagnosed or suspected to have non-alcoholic fatty liver disease
• Patients 18-70 years of age
• be able to understand and sign on written informed consent
• able to undergo ultrasound and MRI examinations

Exclusion Criteria

• any metal or electronic implants including but not limited to pacemakers, clips, hips
• known history of pregnancy or becoming pregnant during study period
• unable to understand and sign on written informed consent
• intolerant to ultrasound and/or MRI examinations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Thermo-acuostic image acquisition of liver	The hepatic fat estimation will be performed on the same subjects with the use of the thermo-acoustic device and by MRI-PDFF. The data obtained from the two estimations will be compared.
Study Group	MRI-PDFF estimation of hepatic fat	The hepatic fat estimation will be performed on the same subjects with the use of the thermo-acoustic device and by MRI-PDFF. The data obtained from the two estimations will be compared.

Primary Outcome Measures

Name	Time	Method
Correlation of hepatic fat estimation by the thermo-acoustic device with MRI-PDFF technique	one year	The study evaluates if the new thermo-acoustic device can accurately estimate the hepatic fat content among patients with non-alcoholic fatty liver disease to the currently approved method using MRI-PDFF scan.

Secondary Outcome Measures

Name	Time	Method
Evaluate the sensitivity of the thermo-acoustic device in the diagnosis of hepatic steatosis.	One year	Evaluate the sensitivity of the thermo-acoustic device in diagnosis presence of hepatic steatosis among patients with MRI-PDFF finding of more than 15% hepatic steatosis
Evaluate the best and ideal number of the anatomical site for thermo-acoustic evaluation of liver	One year	The study evaluates the number of estimation required and the appropriate anatomical site to evaluate the liver to obtain best results

Trial Locations

Locations (1)

Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States