Normal Liver Stiffness by MR Elastography

Children's Hospital Medical Center, Cincinnati101 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

101

Conditions

Liver Diseases

Interventions

MRIDEVICE

Will receive a one time research MRI (MR elastography)

Blood drawDIAGNOSTIC_TEST

Will receive a one time blood draw to confirm healthy liver status

Eligibility

Sex: ALLMin age: 7 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: 30 minutes

Secondary Outcomes

Cross-platform Variability

To assess for cross-platform (different MRI vendors) variability in normal MRI liver stiffness values

Time frame: 30 minutes

Cross-field Strength

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

Time frame: 30 minutes

Sex-related Differences

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

Time frame: 30 minutes

Data from ClinicalTrials.gov

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