Clinical trial NCT05242666: Quantiative MRI and Myelin-PET for the Assessment of Degenerative Cervical Myelopathy
Official title: Evaluating Advanced Imaging Techniques for Use in the Assessment of Degenerative Cervical Myelopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Spondylosis With Myelopathy
Degenerative Cervical Myelopathy
Keywords: Positron Emission Tomography
Magnetic Resonance Imaging
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Wolfson Brain Imaging Centre
First posted: 2022-02-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Observational study of patients undergoing surgery for degenerative cervical myelopathy, allocated to receive an additional form of imaging assessment before and after surgery.
Primary purpose: OTHER

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.

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 progressive loss of bodily function.

Surgery will remove compression and stop injury. However, for a full recovery, it must occur before irreversible spinal cord damage. Current assessments cannot provide this information and today, 95% of patients are left disabled: an assessment that measures spinal cord damage would change this tomorrow.

Imaging advances, well established for measuring disease of the brain, have the potential to provide this in DCM, but requires further investigation. This is the subject of this proposed application: specifically, to investigate 3 different but promising imaging approaches for the assessment of DCM:

1. Advanced magnetic resonance imaging (MRI) to image within the spinal cord
2. Advanced MRI to measure the changes that occur within the brain following DCM
3. Positron Emission Tomography (PET) to measure the active disease biology within the spinal cord.

Individuals with a diagnosis of DCM, will be invited to undergo one of these options, before and after their surgical treatment. Clinical measures used in routine practice will be noted, in order to draw comparisons with imaging. A healthy control group will also be used for MRI imaging, in order to identify changes specific to DCM. Aside from the additional imaging, there will be no changes in routine care.

Eligibility criteria: Inclusion Criteria

1. Participant has a diagnosis of DCM, based on a combination of symptoms, signs and conventional MRI findings (Table 2)
2. Participant is scheduled for surgical treatment for DCM
3. Participant is willing and able to give informed consent for participation in the study;
4. Male or Female, aged 18 - 85 years (inclusive);

Exclusion Criteria

The participant may not enter the study if ANY of the following apply:

1. Participant unable to give informed consent;
2. Participant unable to undergo, or intolerant of MR or PET/MR imaging
3. 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.
4. 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.

1. Female patients who are pregnant or breast-feeding
2. Participants whose DCM surgery will include the insertion of metallic implants to secure multiple levels of the spine (technically termed 'instrumentation')
3. Age \<40

4.3.2 Volunteers

Inclusion Criteria

1. Participant is willing and able to give informed consent for participation in the study;
2. Male or Female, aged 18 - 85 years (inclusive); Exclusion Criteria

The participant may not enter the study if ANY of the following apply:

1. Participant unable to give informed consent;
2. Participant unable to undergo, or intolerant of MR imaging
3. 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.

Primary outcomes:
measure: Modified Japanese Orthopaedics Association (mJOA)
timeFrame: 6 Months Post Surgery
Secondary outcomes:
measure: Short-Form 36 (SF-36)
timeFrame: Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
measure: Numeric Rating Scale (NRS) Pain
timeFrame: Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
measure: Myelopathy.org Symptom Inventory [MOSI]
timeFrame: Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
measure: Neurological Exam
timeFrame: Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital
state: Cambridgeshire
Study officials:
References:
citation: 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.