Clinical trial NCT00599183: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Spine Herniation
Keywords: Cervical spine herniation
MRI cervical spine
Diffusion tensor imaging cervical spine
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Whether DTI alone or with tractography demonstrates greater sensitivity and specificity as a diagnostic tool for this disorder
timeFrame: 6 week follow up scans
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center - S. Mark Taper Foundation Imaging Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Franklin Moser, MD
role: PRINCIPAL_INVESTIGATOR
References: