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Completed

NCT Number: NCT03235414

Normal Liver Stiffness by MR Elastography

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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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Device

Will receive a one time research MRI (MR elastography)

Blood draw

Diagnostic Test

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

Primary outcomes

  1. Liver Stiffness

    Time frame: 30 minutes

    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 outcomes

  1. Cross-platform Variability

    Time frame: 30 minutes

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

  2. Cross-field Strength

    Time frame: 30 minutes

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

  3. Sex-related Differences

    Time frame: 30 minutes

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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Children's Hospital of Philadelphia
  • Massachusetts General Hospital
  • Washington University School of Medicine

Registry information

Official study title

Determination of Normal Liver Stiffness by MR Elastography in Children

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 1, 2017
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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