NCT01382290

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

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2.5 years until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

September 13, 2005

Last Update Submit

August 5, 2016

Conditions

Keywords

MRISpineDiffusion

Interventions

MRIPROCEDURE

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Location

MeSH Terms

Conditions

Spinal Cord InjuriesArnold-Chiari Malformation

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesNeural Tube DefectsNervous System MalformationsCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Richard Jones, PhD

    Emory University/Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR
0

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

Locations