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Normal Liver Stiffness by MR Elastography

Not Applicable
Completed
Conditions
Liver Diseases
Interventions
Device: MRI
Diagnostic 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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
NormalsMRIWill receive an MRI and a blood draw
NormalsBlood drawWill receive an MRI and a blood draw
Primary Outcome Measures
NameTimeMethod
Liver StiffnessDuring 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
NameTimeMethod
Cross-field StrengthDuring investigation

To assess cross-field strength (1.5T vs. 3T) variability in normal MRI liver stiffness values

Sex-related DifferencesDuring investigation

To assess for sex-related (male vs. female) differences in normal MRI liver stiffness values

Cross-platform VariabilityDuring 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

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