Ultrasound Quantification of Liver Fat
Completed
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Interventions
- Device: Magnetic Resonance Imaging (MRI)Device: Ultrasound Imaging
- Registration Number
- NCT04523584
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Hepatic Steatosis Magnetic Resonance Imaging (MRI) \<5% liver fat fraction by MRI PDFF Hepatic Steatosis Ultrasound Imaging \<5% liver fat fraction by MRI PDFF No Hepatic Steatosis Magnetic Resonance Imaging (MRI) \>5% liver fat fraction by MRI PDFF No Hepatic Steatosis Ultrasound Imaging \>5% liver fat fraction by MRI PDFF
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States