Ultrasound Quantification of Liver Fat

Children's Hospital Medical Center, Cincinnati192 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

192

Conditions

Non-Alcoholic Fatty Liver Disease

Interventions

Magnetic Resonance Imaging (MRI)DEVICE

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

Ultrasound ImagingDEVICE

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

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

MRI PDFF correlation/agreement to UDFF

Liver fat % derived using MR PDFF will be compared to UDFF

Time frame: Single time point-30 minute MRI/30 minute Ultrasound

Data from ClinicalTrials.gov

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