Normal Liver Stiffness by MR Elastography

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-19

Study Completion Date

2020-07-24

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.

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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.

Conditions

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Liver Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Normals

Will receive an MRI and a blood draw

Group Type EXPERIMENTAL

MRI

Intervention Type DEVICE

Will receive a one time research MRI (MR elastography)

Blood draw

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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MRI

Will receive a one time research MRI (MR elastography)

Intervention Type DEVICE

Blood draw

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

Intervention Type DIAGNOSTIC_TEST

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

Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes