NCT04302051

Assessment of Fatty Liver With Thermo-acoustic Device

Feasibility Study for Quantifying Fatty Liver Using Thermo-acoustic Imaging

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-02
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-03-10
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States