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Diffusion Tensor Imaging of Myelopathy (DTI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03665935
Recruitment Status : Not yet recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Information provided by (Responsible Party):
MGMaghrabi, Assiut University

Tracking Information
First Submitted Date September 6, 2018
First Posted Date September 11, 2018
Last Update Posted Date September 11, 2018
Estimated Study Start Date September 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2018)
To determine the usefulness of diffusion tensor imaging (DTI) and fiber tracking in evaluation of myelopathy. [ Time Frame: one year ]
assessing white matter tract affection in various disease and damage involving the spinal cord using the DTI indices, quantitatively using ADC and FA measurement and qualitatively using tractogram to assess spinal cord lesions and compare the results to conventional MRI sequences
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Diffusion Tensor Imaging of Myelopathy
Official Title Role of Diffusion Tensor Imaging in Evaluation of Myelopathy
Brief Summary

Myelopathy describes any neurologic deficit related to the spinal cord. Myelopathy is caused by various pathological states of the human spinal cord, including tumors, inflammatory lesions, spinal cord compression and degenerative myelopathy. Clinically, the diagnosis of myelopathy depends on localization of the neurologic finding to the spinal cord, rather than the brain or peripheral nervous system and then to a particular segment of the spinal cord.

Magnetic resonance imaging (MRI) plays an essential role in the diagnosis and follow-up of the lesions of the spinal cord using conventional MRI T1- and T2-weighted sequences. Sometimes a studied spinal cord may appear normal on conventional MRI even though patients have symptoms of myelopathy causing a discrepancy between MRI findings and clinical findings.

Diffusion tensor imaging (DTI) is an advanced non-invasive MR imaging technique which assesses the microstructural integrity of nerve fiber tracts.

Detailed Description

A number of 70 patient with myelopathy included within the study.

DTI is used primarily for assessing white matter of the brain and spinal cord. DTI can depict alterations to the white matter tract and quantify these changes. Disturbances of diffusion (restriction or increase) may be assessed quantitatively by measurements of apparent diffusion coefficient (ADC). The apparent diffusion coefficient (ADC), is used to measure diffusive strength. Diffusion anisotropy can be assessed quantitatively by using the fractional anisotropy (FA) parameter, which may be also visualized on fractional anisotropy maps. FA is considered as a marker of white matter integrity.

Image acquisition will be conducted on a 1.5-Tesla MR scanner.

The imaging will be done throughout the following sequences:

  1. Conventional MRI sequences: sagittal T1W, sagittal and axial T2W sequences.
  2. DTI sequence: Single-shot spin-echo echo-planar imaging (EPI) and parallel imaging techniques to achieve motion-free and higher signal-to-noise ratio (SNR) DTI.

Post processing:

The diffusion-tensor imaging data is transferred to an offline workstation utilizing software used for reconstruction of the Diffusion Tensor imaging (DTI) with regions of interest were defined and measured on the ADC and fractional anisotropy (FA) maps. diffusion tensor tractogram will be constructed on the acquired data source.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population A 70 patient with myelopathy will be included in the study. the study will be performed at radiology department in Assiut University Hospital. Using Magnetic Resonance imaging device 1.5 tesla scanners. First imaging the spine by acquiring the conventional sequences and second the diffusion tensor sequence.
Condition Myelopathy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Kamble RB, Venkataramana NK, Naik AL, Rao SV. Diffusion tensor imaging in spinal cord injury. Indian J Radiol Imaging. 2011 Jul;21(3):221-4. doi: 10.4103/0971-3026.85372.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 8, 2018)
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical symptoms of myelopathy

Exclusion Criteria:

  • Previous spine surgery
  • Spine radiation therapy
  • Cerebral palsy
  • Contraindication to MR imaging.
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contact: Abd El-Karem Hasan, professor 01224652032
Contact: Mohamed Zidan, A.professor 01001121365
Listed Location Countries Not Provided
Removed Location Countries  
Administrative Information
NCT Number NCT03665935
Other Study ID Numbers DTI in myelopathy
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party MGMaghrabi, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Principal Investigator: Mona Gouda, ass lecturer Assiut University
PRS Account Assiut University
Verification Date September 2018