Quantiative MRI and Myelin-PET for the Assessment of Degenerative Cervical Myelopathy
IMAGE-DCM
Evaluating Advanced Imaging Techniques for Use in the Assessment of Degenerative Cervical Myelopathy
1 other identifier
interventional
100
1 country
1
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 pathophysiology and natural history of DCM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2019
CompletedStudy Start
First participant enrolled
April 17, 2021
CompletedFirst Posted
Study publicly available on registry
February 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedMay 27, 2022
May 1, 2022
3.8 years
December 5, 2019
May 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Japanese Orthopaedics Association (mJOA)
6 Months Post Surgery
Secondary Outcomes (4)
Short-Form 36 (SF-36)
Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
Numeric Rating Scale (NRS) Pain
Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
Myelopathy.org Symptom Inventory [MOSI]
Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
Neurological Exam
Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
Study Arms (4)
DCM1: MRI Spinal Cord
OTHER3T MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery.
DCM2: MRI Brain and Spinal Cord
OTHER3T MR Imaging of the brain and cervical spinal cord, before and at 3-6 months after surgery. A subset will also be invited to undergo 7T MRI Brain and Spinal Cord Imaging.
DCM3: [11C]-PIB MR/PET Cervical Spinal Cord
OTHER\[11C\]PIB PET/MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery.
Healthy Volunteer: MRI Brain and Spinal Cord
OTHERAge-Matched Healthy Controls will undergo MRI Brain and Spinal Cord. A subset will also be invited to undergo interval imaging at 3-6 months.
Interventions
Patients will undergo either Magnetic Resonance Imaging of the Spinal Cord
Patients will undergo combination MRI/PET using a \[11C\]PIB radiotracer
3T MR Imaging of the Brain
7T MR Imaging of the Spinal Cord
Eligibility Criteria
You may qualify if:
- 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);
You may not qualify if:
- 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
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cambridge University Hospital
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Related Publications (1)
Davies BM, Mowforth OD, Smith EK, Kotter MR. Degenerative cervical myelopathy. BMJ. 2018 Feb 22;360:k186. doi: 10.1136/bmj.k186. No abstract available.
PMID: 29472200BACKGROUND
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Honorary Specialist Registrar, Department of Neurosurgery, Cambridge University Hospital
Study Record Dates
First Submitted
December 5, 2019
First Posted
February 16, 2022
Study Start
April 17, 2021
Primary Completion
February 1, 2025
Study Completion
February 1, 2025
Last Updated
May 27, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share
Annoymised Data will be made available, for collaboration, at the discretion of the senior investigators upon completion of the study.