Ultrasound Quantification of Liver Fat

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

COMPLETED

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-08

Study Completion Date

2021-07-22

Brief Summary

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The investigators plan a prospective study designed to evaluate the accuracy of a new ultrasound method for quantification of liver fat content.

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Detailed Description

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MRI proton density fat fraction (PDFF) will serve as the reference standard for liver fat fraction measurements. The strength of agreement between ultrasound derived fat fraction (UDFF) and PDFF will be the outcome of interest for this study.

Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hepatic Steatosis

\<5% liver fat fraction by MRI PDFF

Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

Participants will undergo MR imaging of the liver. Liver PDFF will be measured.

Ultrasound Imaging

Intervention Type DEVICE

Participants will undergo ultrasound imaging of the liver. UDFF and shear wave speed (US-SWS) will be measured.

No Hepatic Steatosis

\>5% liver fat fraction by MRI PDFF

Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

Participants will undergo MR imaging of the liver. Liver PDFF will be measured.

Ultrasound Imaging

Intervention Type DEVICE

Participants will undergo ultrasound imaging of the liver. UDFF and shear wave speed (US-SWS) will be measured.

Interventions

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Magnetic Resonance Imaging (MRI)

Participants will undergo MR imaging of the liver. Liver PDFF will be measured.

Intervention Type DEVICE

Ultrasound Imaging

Participants will undergo ultrasound imaging of the liver. UDFF and shear wave speed (US-SWS) will be measured.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients 16 years of age or older with known fatty liver disease (based upon prior MRI or ultrasound), or at risk for fatty liver disease (obese).

Exclusion Criteria

* Subject under the age of 16
* Pregnant subject
* Subjects who cannot cooperate with performance of the ultrasound exam
* Subjects who cannot cooperate with performance of the MRI exam
* Subjects who have contraindications to MRI
* Subjects who might require sedation or anesthesia to undergo study imaging

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No