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| Sponsored by: |
Cedars-Sinai Medical Center |
|---|---|
| Information provided by: | Cedars-Sinai Medical Center |
| ClinicalTrials.gov Identifier: | NCT00599183 |
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: | Diagnostic, Non-Randomized, Open Label, Single Group Assignment |
| Official Title: | Diffusion Tensor (Magnetic Resonance) Imaging and Tractography in Herniation of the Cervical Spine: An Investigator-Initiated Pilot Study |
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Laura Blaszkiewicz, RN | 310-423-4302 | blaszkiewicz@cshs.org |
| Contact: Rene J. Siegel | 310-423-3398 | siegelr@cshs.org |
| United States, California | |
| Cedars-Sinai Medical Center - S. Mark Taper Foundation Imaging Center | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Contact: Rene J. Siegel 310-423-3398 siegelr@cshs.org | |
| Principal Investigator: Franklin G. Moser, M.D. | |
| Sub-Investigator: Ajay Ananda, M.D. | |
| Sub-Investigator: Nader Binesh, Ph.D. | |
| Sub-Investigator: Gabriel Hunt, M.D. | |
| Sub-Investigator: Leonel Hunt, M.D. | |
| Sub-Investigator: Marcel Maya, M.D. | |
| Sub-Investigator: Elton J Tourje, M.D. | |
| Sub-Investigator: Barry D. Pressman, M.D. | |
| Sub-Investigator: J. P. Johnson, M.D. | |
| Sub-Investigator: Brian Perri, D.O. | |
| Principal Investigator: | Franklin Moser, MD | Cedars-Sinai Medical Center |
More Information
| Responsible Party: | Cedars-Sinai Medical Center ( Franklin G. Moser, M.D. ) |
| Study ID Numbers: | CSMC IRB PRO00009246 |
| Study First Received: | January 11, 2008 |
| Last Updated: | January 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00599183 |
| Health Authority: | United States: Institutional Review Board |
|
Cervical spine herniation MRI cervical spine Diffusion tensor imaging cervical spine |
|
Pathological Conditions, Anatomical Hernia |
