Normal Liver Stiffness by MR Elastography

Liver Diseases Clinical Trial

Official title:

Determination of Normal Liver Stiffness by MR Elastography in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235414
• Other study ID #: CIN001-Liver stiffness
• Status: Completed
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: July 24, 2020

Study information

• Verified date: July 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 24, 2020
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Children's Hospital of Philadelphia, Massachusetts General Hospital, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During investigation
Secondary	Cross-platform Variability	To assess for cross-platform (different MRI vendors) variability in normal MRI liver stiffness values	During Investigation
Secondary	Cross-field Strength	To assess cross-field strength (1.5T vs. 3T) variability in normal MRI liver stiffness values	During investigation
Secondary	Sex-related Differences	To assess for sex-related (male vs. female) differences in normal MRI liver stiffness values	During investigation