Non-Alcoholic Fatty Liver Disease
Conditions
Brief summary
The investigators plan a prospective study designed to evaluate the accuracy of a new ultrasound method for quantification of liver fat content.
Detailed 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.
Interventions
DEVICEMagnetic Resonance Imaging (MRI)
Participants will undergo MR imaging of the liver. Liver PDFF will be measured.
DEVICEUltrasound Imaging
Participants will undergo ultrasound imaging of the liver. UDFF and shear wave speed (US-SWS) will be measured.
Sponsors
Siemens Medical Solutions
Children's Hospital Medical Center, Cincinnati
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI PDFF correlation/agreement to UDFF | Single time point-30 minute MRI/30 minute Ultrasound | Liver fat % derived using MR PDFF will be compared to UDFF |
Countries
United States
Outcome results
None listed