Ultrasound Quantification of Liver Fat

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Device: Magnetic Resonance Imaging (MRI); Device: Ultrasound Imaging

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04523584

CIN_US Liver Fat

Details and patient eligibility

About

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

Full description

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.

Enrollment: 192 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

192 participants in 2 patient groups

Hepatic Steatosis

Description:

\<5% liver fat fraction by MRI PDFF

Treatment:

Device: Ultrasound Imaging

Device: Magnetic Resonance Imaging (MRI)

No Hepatic Steatosis

Description:

\>5% liver fat fraction by MRI PDFF

Treatment:

Device: Ultrasound Imaging

Device: Magnetic Resonance Imaging (MRI)