Normal Liver Stiffness by MR Elastography

Determination of Normal Liver Stiffness by MR Elastography in Children

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

Study Overview

• Status: Completed
• Conditions: Liver Diseases
• Intervention / Treatment: Device: MRI; Diagnostic test: Blood draw

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normals; Will receive an MRI and a blood draw	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Massachusetts General Hospital; Children's Hospital of Philadelphia; Washington University School of Medicine
• Investigators: Principal Investigator: Andrew Trout, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

General Publications

• Trout AT, Anupindi SA, Gee MS, Khanna G, Xanthakos SA, Serai SD, Baikpour M, Calle-Toro JS, Ozturk A, Zhang B, Dillman JR. Normal Liver Stiffness Measured with MR Elastography in Children. Radiology. 2020 Dec;297(3):663-669. doi: 10.1148/radiol.2020201513. Epub 2020 Sep 22.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2018
• Primary Completion (Actual): June 25, 2020
• Study Completion (Actual): July 24, 2020

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: CIN001-Liver stiffness

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes