Assessment of Fatty Liver With Thermo-acoustic Device

Feasibility Study for Quantifying Fatty Liver Using Thermo-acoustic Imaging

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.

Study Overview

• Status: Recruiting
• Conditions: Fatty Liver; NAFLD; Non-Alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; Non-alcoholic Fatty Liver; NASH; Fatty Liver Disease
• Intervention / Treatment: Diagnostic test: Thermo-acuostic image acquisition of liver; Diagnostic test: MRI-PDFF estimation of hepatic fat

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 Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: ACHUTHAN MD SOURIANARAYANANE, MD; Phone Number: 4149556850; Email: asourianar@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Froedtert Hospital
      • Contact: Achuthan Sourianarayanane, MD; Phone Number: 414-955-6850; Email: asourianar@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult volunteers with diagnosed or suspected for non-alcoholic fatty liver disease will be recruited in the study. Patients who meet inclusion and exclusion criteria will be included in the study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; 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.	Diagnostic test: Thermo-acuostic image acquisition of liver; Estimation of hepatic fat content with thermo-acoustic device; Diagnostic test: MRI-PDFF estimation of hepatic fat; Estimation of hepatic fat content with MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: ENDRA Life Sciences, Inc.
• Investigators: Principal Investigator: ACHUTHAN SOURIANARAYANANE, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: PRO00036361

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No