Study Stopped
No patients were enrolled, due to logistic difficulties, no funding was acquired.
Magnetic Resonance Imaging of the Spine
MRIS
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Diffusion-weighted (DW) magnetic resonance imaging (MRI) imaging is a well established method for detecting acute injury to the brain and is used on all children undergoing an MRI brain scan at Children's Healthcare of Atlanta. The possibility of using DW MRI to study other areas of the body, such as the spinal cord, has been recognised as having great clinical potential. However, two main problems have hindered the clinical application of the technique; firstly, the extreme motion sensitivity of the technique meant that respiratory motion have hampered clinical studies. Secondly, the close proximity of the spinal cord to the bones in the spinal column complicates the application of the techniques developed for the brain to the spine. Recently, several techniques have been developed which address these problems and these are now available on the MRI scanners used at Children's Healthcare of Atlanta. We now wish to evaluate how well these techniques work on children in a routine clinical setting. For this reason we wish to add a single scan of the spine to the imaging protocol of children receiving a routine scan of the brain or spine. This will permit us to evaluate the image quality in both normal and abnormal spines. We plan on enrolling 60 patients with normal spines and 30 patients with abnormal spines. No additional sedation and/or contrast will be required and the additional imaging time for the diffusion studies will be less than 10 minutes. Parental consent will be a pre-requisite for any patient to be enrolled into the study.
Trial Health
Trial Health Score
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Started Mar 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2005
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedAugust 9, 2016
August 1, 2016
1.8 years
September 13, 2005
August 5, 2016
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients with tethered cords.
- Patients with Chiari I malformations.
- Normal children undergoing a MRI of the spine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Childrens Healthcare at Scottish Rite
Atlanta, Georgia, 30342, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Jones, PhD
Emory University/Children's Healthcare of Atlanta
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
June 27, 2011
Study Start
March 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
August 9, 2016
Record last verified: 2016-08