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Normal Liver Stiffness by MR Elastography

Cincinnati Children's Hospital Medical Center logo

Cincinnati Children's Hospital Medical Center

Status

Completed

Conditions

Liver Diseases

Treatments

Diagnostic Test: Blood draw
Device: MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT03235414
CIN001-Liver stiffness

Details and patient eligibility

About

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

Full 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.

Enrollment

101 patients

Sex

All

Ages

7 to 17 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

101 participants in 1 patient group

Normals
Experimental group
Description:
Will receive an MRI and a blood draw
Treatment:
Diagnostic Test: Blood draw
Device: MRI

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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