Normal Liver Stiffness by MR Elastography
Primary Purpose
Liver Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Blood draw
Sponsored by
About this trial
This is an interventional diagnostic trial for Liver Diseases
Eligibility Criteria
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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Normals
Arm Description
Will receive an MRI and a blood draw
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Cross-platform Variability
To assess for cross-platform (different MRI vendors) variability in normal MRI liver stiffness values
Cross-field Strength
To assess cross-field strength (1.5T vs. 3T) variability in normal MRI liver stiffness values
Sex-related Differences
To assess for sex-related (male vs. female) differences in normal MRI liver stiffness values
Full Information
NCT ID
NCT03235414
First Posted
July 28, 2017
Last Updated
August 27, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Massachusetts General Hospital, Washington University School of Medicine, Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT03235414
Brief Title
Normal Liver Stiffness by MR Elastography
Official Title
Determination of Normal Liver Stiffness by MR Elastography in Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 19, 2018 (Actual)
Primary Completion Date
June 25, 2020 (Actual)
Study Completion Date
July 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Massachusetts General Hospital, Washington University School of Medicine, Children's Hospital of Philadelphia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normals
Arm Type
Experimental
Arm Description
Will receive an MRI and a blood draw
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
Will receive a one time research MRI (MR elastography)
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood draw
Intervention Description
Will receive a one time blood draw to confirm healthy liver status
Primary Outcome Measure Information:
Title
Liver Stiffness
Description
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
Time Frame
During investigation
Secondary Outcome Measure Information:
Title
Cross-platform Variability
Description
To assess for cross-platform (different MRI vendors) variability in normal MRI liver stiffness values
Time Frame
During Investigation
Title
Cross-field Strength
Description
To assess cross-field strength (1.5T vs. 3T) variability in normal MRI liver stiffness values
Time Frame
During investigation
Title
Sex-related Differences
Description
To assess for sex-related (male vs. female) differences in normal MRI liver stiffness values
Time Frame
During investigation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Trout, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32960728
Citation
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.
Results Reference
derived
Learn more about this trial
Normal Liver Stiffness by MR Elastography
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