Status:
UNKNOWN
Quantiative MRI and Myelin-PET for the Assessment of Degenerative Cervical Myelopathy
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Wolfson Brain Imaging Centre
Conditions:
Cervical Spondylosis With Myelopathy
Degenerative Cervical Myelopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To use advanced imaging techniques, including MRI Brain and Spinal Cord, and MRI/PET Spinal Cord to provide an assessment of Degenerative Cervical Myelopathy to improve understanding of the pathophysi...
Detailed Description
Degenerative Cervical Myelopathy (DCM) is a disabling condition affecting up to 2% of adults. It arises when arthritic changes in the cervical spine compress and injure the spinal cord, causing progre...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Participant has a diagnosis of DCM, based on a combination of symptoms, signs and conventional MRI findings (Table 2)
- Participant is scheduled for surgical treatment for DCM
- Participant is willing and able to give informed consent for participation in the study;
- Male or Female, aged 18 - 85 years (inclusive);
- Exclusion Criteria
- The participant may not enter the study if ANY of the following apply:
- Participant unable to give informed consent;
- Participant unable to undergo, or intolerant of MR or PET/MR imaging
- Participant has co-existing or prior neurological disease of the brain, spinal cord, or peripheral nervous system, including but not limited to, Lumbar Canal Stenosis, Multiple Sclerosis, Dementia and Parkinson's Disease.
- Contraindications to MRI: These are chiefly the presence of metallic implants that are not known to be MR safe, particularly in terms of movement or substantial heating. Devices that may need to be considered in this context include (this is not an exhaustive list, and this issue will be considered on a case-by-case basis for any implant or external fixation device):
- Cerebral aneurysm clips not known to be MR safe
- Intra-ocular metallic shards
- Cochlear implants
- Automatic cardioverter defibrillators
- Nerve stimulation units
- Other electronic implants, such as cardiac pacemakers
- Orthopedic external fixations
- Exclusion Criteria Specific for PET/MR Imaging Stream
- In addition, the following exclusion criteria will apply for PET imaging, to reduce implications of exposure to ionising radiation, or interpretation of findings.
- Female patients who are pregnant or breast-feeding
- Participants whose DCM surgery will include the insertion of metallic implants to secure multiple levels of the spine (technically termed 'instrumentation')
- Age \<40
- 3.2 Volunteers
- Inclusion Criteria
- Participant is willing and able to give informed consent for participation in the study;
- Male or Female, aged 18 - 85 years (inclusive); Exclusion Criteria
- The participant may not enter the study if ANY of the following apply:
- Participant unable to give informed consent;
- Participant unable to undergo, or intolerant of MR imaging
- Participant has co-existing or prior neurological disease of the brain, spinal cord, or peripheral nervous system, including but not limited to, Lumbar Canal Stenosis, Multiple Sclerosis, Dementia and Parkinson's Disease.
Exclusion
Key Trial Info
Start Date :
April 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05242666
Start Date
April 17 2021
End Date
February 1 2025
Last Update
May 27 2022
Active Locations (1)
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1
Cambridge University Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ