MyelopathyDTINCT03665935
Diffusion Tensor Imaging of Myelopathy
An observational study of Myelopathy, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myelopathy
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Clinical symptoms of myelopathy
Who cannot join
- Previous spine surgery
- Spine radiation therapy
- Cerebral palsy
- Contraindication to MR imaging.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Diffusion Tensor Imaging in Evaluation of Myelopathy
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.
Read the 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:
- Conventional MRI sequences: sagittal T1W, sagittal and axial T2W sequences.
- 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.
- Conditions
- Myelopathy
- Medical subject headings
- Spinal Cord Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the usefulness of diffusion tensor imaging (DTI) and fiber tracking in evaluation of myelopathy.
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study startSep 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyelopathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MGMaghrabi, Assiut University
- Investigators
- Mona Gouda, ass lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665935
- Sponsor's protocol ID
- DTI in myelopathy
- Acronym
- DTI
- Status last verified
- Sep 2018
- First submitted
- 6 Sep 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 22013299
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Diffusion Tensor Imaging in Evaluation of Myelopathy
- ClinicalTrials.gov ID
- NCT03665935
- Acronym / sponsor ID
- DTI / DTI in myelopathy
- Conditions
- Myelopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Conventional MRI sequences: sagittal T1W, sagittal and axial T2W sequences.
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Clinical symptoms of myelopathy
Key exclusion criteria (4 listed)
- Previous spine surgery
- Spine radiation therapy
- Cerebral palsy
- Contraindication to MR imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Background: PubMed 22013299Kamble 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Gouda, ass lecturer principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Myelopathy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abd El-Karem Hasan, professor (01224652032, abdelkarem_5555@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the usefulness of diffusion tensor imaging (DTI) and fiber tracking in evaluation of myelopathy. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03665935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.