NCT03235414

Normal Liver Stiffness by MR Elastography

Determination of Normal Liver Stiffness by MR Elastography in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Liver Diseases

Interventions

Type	Name	Description
DEVICE	MRI	Will receive a one time research MRI (MR elastography)
DIAGNOSTIC_TEST	Blood draw	Will receive a one time blood draw to confirm healthy liver status

Timeline

• Start date: 2018-02-19
• Primary completion: 2020-06-25
• Completion: 2020-07-24
• First posted: 2017-08-01
• Last updated: 2020-09-16
• Results posted: 2020-08-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study