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Quantiative MRI and Myelin-PET for the Assessment of Degenerative Cervical Myelopathy (IMAGE-DCM)

Primary Purpose

Cervical Spondylosis With Myelopathy, Degenerative Cervical Myelopathy

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
3T MR Imaging of the cervical spinal cord
Positron Emission Tomography using [11C]PIB
3T MR Imaging of the Brain
7T MR Imaging of the Spinal Cord
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cervical Spondylosis With Myelopathy focused on measuring Positron Emission Tomography, Magnetic Resonance Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cambridge University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

DCM1: MRI Spinal Cord

DCM2: MRI Brain and Spinal Cord

DCM3: [11C]-PIB MR/PET Cervical Spinal Cord

Healthy Volunteer: MRI Brain and Spinal Cord

Arm Description

3T MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery.

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.

[11C]PIB PET/MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery.

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.

Outcomes

Primary Outcome Measures

Modified Japanese Orthopaedics Association (mJOA)

Secondary Outcome Measures

Short-Form 36 (SF-36)
Quality of Life (0-100, where 50 is normal for geographical population. Higher score is better)
Numeric Rating Scale (NRS) Pain
Pain Score (0-10, where 10 is maximum pain, and 0 is no pain. Lower score is better)
Myelopathy.org Symptom Inventory [MOSI]
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).
Neurological Exam
Routine Neurological Exam (Motor and Sensory changes to hands, arms and legs, long-tract signs in cluded reflexes, Hoffman's and Babbinski's reflexes)

Full Information

First Posted
December 5, 2019
Last Updated
May 26, 2022
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom, Wolfson Brain Imaging Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05242666
Brief Title
Quantiative MRI and Myelin-PET for the Assessment of Degenerative Cervical Myelopathy
Acronym
IMAGE-DCM
Official Title
Evaluating Advanced Imaging Techniques for Use in the Assessment of Degenerative Cervical Myelopathy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2021 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom, Wolfson Brain Imaging Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spondylosis With Myelopathy, Degenerative Cervical Myelopathy
Keywords
Positron Emission Tomography, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DCM1: MRI Spinal Cord
Arm Type
Other
Arm Description
3T MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery.
Arm Title
DCM2: MRI Brain and Spinal Cord
Arm Type
Other
Arm Description
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.
Arm Title
DCM3: [11C]-PIB MR/PET Cervical Spinal Cord
Arm Type
Other
Arm Description
[11C]PIB PET/MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery.
Arm Title
Healthy Volunteer: MRI Brain and Spinal Cord
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
3T MR Imaging of the cervical spinal cord
Intervention Description
Patients will undergo either Magnetic Resonance Imaging of the Spinal Cord
Intervention Type
Other
Intervention Name(s)
Positron Emission Tomography using [11C]PIB
Intervention Description
Patients will undergo combination MRI/PET using a [11C]PIB radiotracer
Intervention Type
Other
Intervention Name(s)
3T MR Imaging of the Brain
Intervention Description
3T MR Imaging of the Brain
Intervention Type
Other
Intervention Name(s)
7T MR Imaging of the Spinal Cord
Intervention Description
7T MR Imaging of the Spinal Cord
Primary Outcome Measure Information:
Title
Modified Japanese Orthopaedics Association (mJOA)
Time Frame
6 Months Post Surgery
Secondary Outcome Measure Information:
Title
Short-Form 36 (SF-36)
Description
Quality of Life (0-100, where 50 is normal for geographical population. Higher score is better)
Time Frame
Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
Title
Numeric Rating Scale (NRS) Pain
Description
Pain Score (0-10, where 10 is maximum pain, and 0 is no pain. Lower score is better)
Time Frame
Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
Title
Myelopathy.org Symptom Inventory [MOSI]
Description
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).
Time Frame
Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
Title
Neurological Exam
Description
Routine Neurological Exam (Motor and Sensory changes to hands, arms and legs, long-tract signs in cluded reflexes, Hoffman's and Babbinski's reflexes)
Time Frame
Routine Clinical Care: Baseline and 3-6 Months Post-Operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Davies
Phone
01223 254517
Email
benjamin.davies4@nhs.net
Facility Information:
Facility Name
Cambridge University Hospital
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Davies
Email
benjamin.davies@addenbrookes.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Annoymised Data will be made available, for collaboration, at the discretion of the senior investigators upon completion of the study.
Citations:
PubMed Identifier
29472200
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.
Results Reference
background

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

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