Evaluating Advanced Imaging Techniques for Use in the Assessment of Degenerative Cervical Myelopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Modified Japanese Orthopaedics Association (mJOA)
研究概览
简要总结
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.
详细描述
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:
- Advanced magnetic resonance imaging (MRI) to image within the spinal cord
- Advanced MRI to measure the changes that occur within the brain following DCM
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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);
排除标准
- •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')
- •4.3.2 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.
研究组 & 干预措施
DCM1: MRI Spinal Cord
3T MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery.
干预措施: 3T MR Imaging of the cervical spinal cord (Diagnostic Test)
DCM2: MRI Brain and Spinal Cord
3T 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.
干预措施: 3T MR Imaging of the cervical spinal cord (Diagnostic Test)
DCM2: MRI Brain and Spinal Cord
3T 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.
干预措施: 3T MR Imaging of the Brain (Other)
DCM2: MRI Brain and Spinal Cord
3T 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.
干预措施: 7T MR Imaging of the Spinal Cord (Other)
DCM3: [11C]-PIB MR/PET Cervical Spinal Cord
[11C]PIB PET/MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery.
干预措施: Positron Emission Tomography using [11C]PIB (Other)
Healthy Volunteer: MRI Brain and Spinal Cord
Age-Matched Healthy Controls will undergo MRI Brain and Spinal Cord. A subset will also be invited to undergo interval imaging at 3-6 months.
干预措施: 3T MR Imaging of the cervical spinal cord (Diagnostic Test)
Healthy Volunteer: MRI Brain and Spinal Cord
Age-Matched Healthy Controls will undergo MRI Brain and Spinal Cord. A subset will also be invited to undergo interval imaging at 3-6 months.
干预措施: 3T MR Imaging of the Brain (Other)
结局指标
主要结局
Modified Japanese Orthopaedics Association (mJOA)
时间窗: 6 Months Post Surgery
次要结局
- Short-Form 36 (SF-36)(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)
- Numeric Rating Scale (NRS) Pain(Routine Clinical Care: Baseline and 3-6 Months Post-Operatively)
- Neurological Exam(Routine Clinical Care: Baseline and 3-6 Months Post-Operatively)
研究者
Benjamin Davies
Honorary Specialist Registrar, Department of Neurosurgery, Cambridge University Hospital
Cambridge University Hospitals NHS Foundation Trust