Assessment of Fatty Liver With Thermo-acoustic Device

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Feasibility Study for Quantifying Fatty Liver Using Thermo-acoustic Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04302051
• Other study ID #: PRO00036361
• Status: Recruiting
• Start date: November 2, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: Medical College of Wisconsin
• Contact: ACHUTHAN MD SOURIANARAYANANE, MD
• Phone: 4149556850
• Email: asourianar[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver Disease
• Liver Diseases
• NAFLD
• NASH
• Non-alcoholic Fatty Liver
• Non-Alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Intervention

Diagnostic Test:
• Thermo-acuostic image acquisition of liver
Estimation of hepatic fat content with thermo-acoustic device
• MRI-PDFF estimation of hepatic fat
Estimation of hepatic fat content with MRI

Locations

Country	Name	City	State
United States	Froedtert Hospital	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	ENDRA Life Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of hepatic fat estimation by the thermo-acoustic device with MRI-PDFF technique	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.	one year
Secondary	Evaluate the best and ideal number of the anatomical site for thermo-acoustic evaluation of liver	The study evaluates the number of estimation required and the appropriate anatomical site to evaluate the liver to obtain best results	One year
Secondary	Evaluate the sensitivity of the thermo-acoustic device in the diagnosis of hepatic steatosis.	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	One year