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

Cervical Spine Herniation Clinical Trial

Official title:

Diffusion Tensor (Magnetic Resonance) Imaging and Tractography in Herniation of the Cervical Spine: An Investigator-Initiated Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599183
• Other study ID #: CSMC IRB PRO00009246
• Status: Completed
• Phase: N/A
• First received: January 11, 2008
• Last updated: July 29, 2013
• Start date: August 2006
• Est. completion date: May 2010

Study information

• Verified date: July 2013
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cervical Spine Herniation
• Hernia

Intervention

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

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center - S. Mark Taper Foundation Imaging Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether DTI alone or with tractography demonstrates greater sensitivity and specificity as a diagnostic tool for this disorder		6 week follow up scans	No

External Links

•   Cedars-Sinai Medical Center Clinical Trials Site search for Moser