Assessment of Fatty Liver with Thermo-acoustic Device

NCT ID: NCT04302051

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-02

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Thermo-acuostic image acquisition of liver

Intervention Type DIAGNOSTIC_TEST

Estimation of hepatic fat content with thermo-acoustic device

MRI-PDFF estimation of hepatic fat

Intervention Type DIAGNOSTIC_TEST

Estimation of hepatic fat content with MRI

Interventions

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Thermo-acuostic image acquisition of liver

Estimation of hepatic fat content with thermo-acoustic device

Intervention Type DIAGNOSTIC_TEST

MRI-PDFF estimation of hepatic fat

Estimation of hepatic fat content with MRI

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ENDRA Life Sciences, Inc.

UNKNOWN

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Achuthan Sourianarayanane

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ACHUTHAN SOURIANARAYANANE, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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ACHUTHAN MD SOURIANARAYANANE, MD

Role: CONTACT

4149556850

Facility Contacts

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Achuthan Sourianarayanane, MD

Role: primary

4149556850

Other Identifiers

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PRO00036361

Identifier Type: -

Identifier Source: org_study_id

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