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Diffusion Tensor (Magnetic Resonance) Imaging and Tractography in Herniation of the Cervical Spine

Primary Purpose

Cervical Spine Herniation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI-Diffusion Tensor Imaging and Tractrography
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Spine Herniation focused on measuring Cervical spine herniation, MRI cervical spine, Diffusion tensor imaging cervical spine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients suspected of having cervical spine herniation.

Exclusion Criteria:

  • Patients not suspected of having cervical spine herniation.
  • Patients in which MRI is contraindicated (patients with embedded metallic objects, including pacemakers, surgical clips, spinal cord stimulators, or prosthetic heart valves.)
  • Patients requiring general anesthesia or conscious sedation--sedation would increase risk to participants.

Sites / Locations

  • Cedars-Sinai Medical Center - S. Mark Taper Foundation Imaging Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Participants will receive baseline conventional MRI of the cervical spine as part of their clinical care with an additional diffusion tensor imaging (DTI)sequence as part of the research; they will complete an anonymized questionnaire about their condition. Participants will receive an MRI with DTI and tractography as part of the research and will complete an anonymized questionnaire about their condition. The baseline and follow up data will be compared.

Outcomes

Primary Outcome Measures

Whether DTI alone or with tractography demonstrates greater sensitivity and specificity as a diagnostic tool for this disorder

Secondary Outcome Measures

Full Information

First Posted
January 11, 2008
Last Updated
July 29, 2013
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00599183
Brief Title
Diffusion Tensor (Magnetic Resonance) Imaging and Tractography in Herniation of the Cervical Spine
Official Title
Diffusion Tensor (Magnetic Resonance) Imaging and Tractography in Herniation of the Cervical Spine: An Investigator-Initiated Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an investigator-iniated pilot study to determine if MRI with diffusion tensor imaging (DTI) and tractography will yield useful information in patients suspected of having cervical spine disc herniation to provide imaging confirmation of whether or not disease is progressing and to assess response to treatment (regardless of treatment provided).
Detailed Description
Conventional MRI (magnetic resonance imaging) is used to confirm disc herniation of the cervical spine. Symptoms of the condition can change before they can be seen by conventional MR images. Therefore, very little gross change can be seen by conventional MRI even after 6 weeks of treatment, either medical or surgical. This study will investigate whether newer MRI techniques, diffusion tensor imaging (DTI) and tractography, are useful in demonstrating gross changes or assessing response to treatment. Consenting patients referred for clinically indicated cervical spine MRI by their treating physicians to confirm cervical disc herniation will receive an additional MRI sequence, diffusion tensor imaging. This will provide a baseline. The DTI sequence will add five minutes to the procedure. Participants will return at 6 weeks for a follow up MRI of the cervical spine to include DTI and tractography. Participants will be asked to complete an anonymized questionnaire at enrollment and at follow up to provide information regarding their condition. MRI is a non-invasive diagnostic study of minimal risk which uses magnets instead of ionizing radiation to acquire images. The images are then assembled by computer. Diffusion tensor imaging (DTI) uses water diffusion to visualize structures in the brain and nervous system. Tractography is performed using DTI and computer post-processing to track the fiber bundles which exist in the brain and spinal cord and visualize them as two and three dimensional images. Both techniques allow radiologists to detect abnormalities, in this case, cervical spine disc herniation. The follow up studies will be compared to the baseline studies to determine which demonstrates the highest sensitivity and specificity in identifying cervical spine abnormalities in general and cervical spine herniation in particular.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spine Herniation
Keywords
Cervical spine herniation, MRI cervical spine, Diffusion tensor imaging cervical spine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Participants will receive baseline conventional MRI of the cervical spine as part of their clinical care with an additional diffusion tensor imaging (DTI)sequence as part of the research; they will complete an anonymized questionnaire about their condition. Participants will receive an MRI with DTI and tractography as part of the research and will complete an anonymized questionnaire about their condition. The baseline and follow up data will be compared.
Intervention Type
Other
Intervention Name(s)
MRI-Diffusion Tensor Imaging and Tractrography
Intervention Description
MRI scan: Baseline: Conventional MRI (as part of clinical care) with additional diffusion tensor imaging (DTI)sequence (research). 6-week follow up: MRI with DTI and tractography as part of the research
Primary Outcome Measure Information:
Title
Whether DTI alone or with tractography demonstrates greater sensitivity and specificity as a diagnostic tool for this disorder
Time Frame
6 week follow up scans

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients suspected of having cervical spine herniation. Exclusion Criteria: Patients not suspected of having cervical spine herniation. Patients in which MRI is contraindicated (patients with embedded metallic objects, including pacemakers, surgical clips, spinal cord stimulators, or prosthetic heart valves.) Patients requiring general anesthesia or conscious sedation--sedation would increase risk to participants.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franklin Moser, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center - S. Mark Taper Foundation Imaging Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Links:
URL
http://apps.csmc.edu/SearchClinicalTrials
Description
Cedars-Sinai Medical Center Clinical Trials Site search for Moser

Learn more about this trial

Diffusion Tensor (Magnetic Resonance) Imaging and Tractography in Herniation of the Cervical Spine

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