Fatty Liver, Fatty Liver Disease, NAFLD, NASH, Non-alcoholic Fatty Liver, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
Conditions
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.
Interventions
DIAGNOSTIC_TESTThermo-acuostic image acquisition of liver
Estimation of hepatic fat content with thermo-acoustic device
DIAGNOSTIC_TESTMRI-PDFF estimation of hepatic fat
Estimation of hepatic fat content with MRI
Sponsors
Medical College of Wisconsin
ENDRA Life Sciences, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORACHUTHAN SOURIANARAYANANE, MD
Medical College of Wisconsin
Outcome results
None listed