Assessment of Fatty Liver With Thermo-acoustic Device

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility Study for Quantifying Fatty Liver Using Thermo-acoustic Imaging

Conditions
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NASH, NAFLD, Non-alcoholic Fatty Liver, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, Fatty Liver, Fatty Liver Disease

Intervention / Treatment
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* Diagnostic Test: Thermo-acuostic image acquisition of liver
* Diagnostic Test: MRI-PDFF estimation of hepatic fat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>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<br>* Estimation of hepatic fat content with thermo-acoustic device<br>Diagnostic Test: MRI-PDFF estimation of hepatic fat<br>* Estimation of hepatic fat content with MRI<br>|

What is the study measuring?
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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 |