Quantiative MRI and Myelin-PET for the Assessment of Degenerative Cervical Myelopathy

Not Applicable

Recruiting

• Conditions: Degenerative Cervical Myelopathy; Cervical Spondylosis With Myelopathy
• Interventions: Other: Positron Emission Tomography using [11C]PIB; Diagnostic Test: 3T MR Imaging of the cervical spinal cord; Other: 3T MR Imaging of the Brain; Other: 7T MR Imaging of the Spinal Cord

• Registration Number: NCT05242666
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2019-12-05
• Study Start: 2021-04-17
• Study First Submitted QC: 2022-02-14
• Study First Posted: 2022-02-16
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-27
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DCM3: [11C]-PIB MR/PET Cervical Spinal Cord	Positron Emission Tomography using [11C]PIB	\[11C\]PIB PET/MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery.
DCM1: MRI Spinal Cord	3T MR Imaging of the cervical spinal cord	3T MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery.
DCM2: MRI Brain and Spinal Cord	3T MR Imaging of the cervical 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.
DCM2: MRI Brain and Spinal Cord	7T MR Imaging of the 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.
Healthy Volunteer: MRI Brain and Spinal Cord	3T MR Imaging of the cervical 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.
Healthy Volunteer: MRI Brain and Spinal Cord	3T MR Imaging of the Brain	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.
DCM2: MRI Brain and Spinal Cord	3T MR Imaging of the Brain	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.

Primary Outcome Measures

Name	Time	Method
Modified Japanese Orthopaedics Association (mJOA)	6 Months Post Surgery

Secondary Outcome Measures

Name	Time	Method
Myelopathy.org Symptom Inventory [MOSI]	Routine Clinical Care: Baseline and 3-6 Months Post-Operatively	Quality of Life and Disease Specific Measure (Range of Myelopathy symptoms are scored as Not present, on an intensity scale of 0 to 10, where 10 is worse).
Short-Form 36 (SF-36)	Routine Clinical Care: Baseline and 3-6 Months Post-Operatively	Quality of Life (0-100, where 50 is normal for geographical population. Higher score is better)
Numeric Rating Scale (NRS) Pain	Routine Clinical Care: Baseline and 3-6 Months Post-Operatively	Pain Score (0-10, where 10 is maximum pain, and 0 is no pain. Lower score is better)
Neurological Exam	Routine Clinical Care: Baseline and 3-6 Months Post-Operatively	Routine Neurological Exam (Motor and Sensory changes to hands, arms and legs, long-tract signs in cluded reflexes, Hoffman's and Babbinski's reflexes)

Trial Locations

Locations (1)

Cambridge University Hospital; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom