Assessment of Fatty Liver with Thermo-acoustic Device

Medical College of Wisconsin

Status: Enrolling

Conditions: Fatty Liver; NASH; Non-alcoholic Steatohepatitis; NAFLD; Fatty Liver Disease; Non-Alcoholic Fatty Liver Disease; Non-alcoholic Fatty Liver

Treatments: Diagnostic Test: MRI-PDFF estimation of hepatic fat; Diagnostic Test: Thermo-acuostic image acquisition of liver

Study type: Observational

Funder types: Other

Identifiers

NCT04302051

PRO00036361

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

75 participants in 1 patient group

Study Group

Description:

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.

Treatment:

Diagnostic Test: Thermo-acuostic image acquisition of liver

Diagnostic Test: MRI-PDFF estimation of hepatic fat