Normal Liver Stiffness by MR Elastography

Study Overview
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Brief Summary
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Healthy children will be recruited to under Magnetic Resonance Imaging (MRI)along with MR elastography to determine normal liver stiffness values.

Detailed Description
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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.

Official Title
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Determination of Normal Liver Stiffness by MR Elastography in Children

Conditions
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Liver Diseases

Intervention / Treatment
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* Device: MRI
* Diagnostic Test: Blood draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 7-17 years No documented history of liver diseases English speaking Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normals<br>Will receive an MRI and a blood draw | Device: MRI<br>* Will receive a one time research MRI (MR elastography)<br>Diagnostic Test: Blood draw<br>* Will receive a one time blood draw to confirm healthy liver status<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Stiffness | 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 | During investigation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cross-platform Variability | To assess for cross-platform (different MRI vendors) variability in normal MRI liver stiffness values | During Investigation | 
| Cross-field Strength | To assess cross-field strength (1.5T vs. 3T) variability in normal MRI liver stiffness values | During investigation | 
| Sex-related Differences | To assess for sex-related (male vs. female) differences in normal MRI liver stiffness values | During investigation |