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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Franklin G. Moser, M.D., Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00599183
First received: January 11, 2008
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention
Cervical Spine Herniation
Other: MRI-Diffusion Tensor Imaging and Tractrography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diffusion Tensor (Magnetic Resonance) Imaging and Tractography in Herniation of the Cervical Spine: An Investigator-Initiated Pilot Study

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: August 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
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.
Other: MRI-Diffusion Tensor Imaging and Tractrography
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599183

Locations
United States, California
Cedars-Sinai Medical Center - S. Mark Taper Foundation Imaging Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Franklin Moser, MD Cedars-Sinai Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Franklin G. Moser, M.D., Director, Neuro-Interventional Imaging; Vice Chair Radiology Research, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00599183     History of Changes
Other Study ID Numbers: CSMC IRB PRO00009246
Study First Received: January 11, 2008
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Cervical spine herniation
MRI cervical spine
Diffusion tensor imaging cervical spine

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 22, 2014