Assessment of Fatty Liver With Thermo-acoustic Device

NCT04302051 | Withdrawn

• 1 other identifier: PRO00036361
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluate the best and ideal number of the anatomical site for thermo-acoustic evaluation of liver

  One year

• Evaluate the sensitivity of the thermo-acoustic device in the diagnosis of hepatic steatosis.

  One year

Study Arms (1)

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; Diagnostic Test: MRI-PDFF estimation of hepatic fat

Interventions

Thermo-acuostic image acquisition of liver DIAGNOSTIC_TEST

Estimation of hepatic fat content with thermo-acoustic device

Study Group

MRI-PDFF estimation of hepatic fat DIAGNOSTIC_TEST

Estimation of hepatic fat content with MRI

Study Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult volunteers with diagnosed or suspected for non-alcoholic fatty liver disease will be recruited in the study. Patients who meet inclusion and exclusion criteria will be included in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• ENDRA Life Sciences, Inc.: collaborator

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• ACHUTHAN SOURIANARAYANANE, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: November 2, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)