Normal Liver Stiffness by MR Elastography
- Conditions
- Liver Diseases
- Interventions
- Device: MRIDiagnostic Test: Blood draw
- Registration Number
- NCT03235414
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- Brief Summary
Healthy children will be recruited to under Magnetic Resonance Imaging (MRI)along with MR elastography to determine normal liver stiffness values.
- Detailed Description
MR elastography (MRE) is playing a growing role in the non-invasive diagnosis and monitoring of liver disease in the pediatric population. There is, however, little data specific to the use of this technique in children with existing data and techniques largely extrapolated from adult studies. Existing studies suggest that liver stiffness values may be different between children and adults \[Etchell, Xanthakos\]. As such there is an unmet need for uniquely pediatric data in both healthy and diseased cohorts. To address the need for such data, the investigators plan a multi-site, prospective study of healthy pediatric (\<18 years of age) volunteers to determine normal liver stiffness measured by MR elastography across the range of MRI equipment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- Age 7-17 years
- No documented history of liver diseases
- English speaking
- NPO less than 4 hours
- Body mass index <10th or > 85th percentile for age
- Documented history of liver disease
- Pregnancy
- Inability to lie still for duration of the MRI
- Inability to breath hold for the duration of the 15-20 second MR elastography sequence
- Standard contraindication to MRI (implanted hardware, etc.)
- Requirement of sedation or general anesthesia for MRI
- Abnormality of any measured liver function test
- Liver fat fraction >5% by MRI PDFF
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Normals MRI Will receive an MRI and a blood draw Normals Blood draw Will receive an MRI and a blood draw
- Primary Outcome Measures
Name Time Method Liver Stiffness During investigation Liver stiffness is a measure of a mechanical property of tissue (stiffness). This can be measured non-invasively by MR elastography, a technique that involves applying an external vibration to the abdomen and measuring the progression of shear waves through the underlying liver using MRI.
Purpose of the study was to determine normal (healthy) liver stiffness as measured by MRE
- Secondary Outcome Measures
Name Time Method Cross-field Strength During investigation To assess cross-field strength (1.5T vs. 3T) variability in normal MRI liver stiffness values
Sex-related Differences During investigation To assess for sex-related (male vs. female) differences in normal MRI liver stiffness values
Cross-platform Variability During Investigation To assess for cross-platform (different MRI vendors) variability in normal MRI liver stiffness values
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States