Assessment of Fatty Liver With Thermo-acoustic Device
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients diagnosed or suspected to have non-alcoholic fatty liver disease
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Patients 18-70 years of age
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be able to understand and sign on written informed consent
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able to undergo ultrasound and MRI examinations
Exclusion Criteria:
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any metal or electronic implants including but not limited to pacemakers, clips, hips
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known history of pregnancy or becoming pregnant during study period
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unable to understand and sign on written informed consent
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intolerant to ultrasound and/or MRI examinations
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Froedtert Hospital | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Medical College of Wisconsin
- ENDRA Life Sciences, Inc.
Investigators
- Principal Investigator: ACHUTHAN SOURIANARAYANANE, MD, Medical College of Wisconsin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO00036361