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

Cervical Spondylosis With Myelopathy Clinical Trial

— IMAGE-DCM  

Official title:

Evaluating Advanced Imaging Techniques for Use in the Assessment of Degenerative Cervical Myelopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05242666
• Other study ID #: 274826
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2021
• Est. completion date: February 1, 2025

Study information

• Verified date: May 2022
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Benjamin Davies
• Phone: 01223 254517
• Email: benjamin.davies4[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervical Spondylosis With Myelopathy
• Spinal Cord Diseases
• Spondylosis

Intervention

Diagnostic Test:
• 3T MR Imaging of the cervical spinal cord
Patients will undergo either Magnetic Resonance Imaging of the Spinal Cord

Other:
• Positron Emission Tomography using [11C]PIB
Patients will undergo combination MRI/PET using a [11C]PIB radiotracer
• 3T MR Imaging of the Brain
3T MR Imaging of the Brain
• 7T MR Imaging of the Spinal Cord
7T MR Imaging of the Spinal Cord

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospital	Cambridge	Cambridgeshire

Sponsors (3)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	National Institute for Health Research, United Kingdom, Wolfson Brain Imaging Centre

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Davies BM, Mowforth OD, Smith EK, Kotter MR. Degenerative cervical myelopathy. BMJ. 2018 Feb 22;360:k186. doi: 10.1136/bmj.k186. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Japanese Orthopaedics Association (mJOA)		6 Months Post Surgery
Secondary	Short-Form 36 (SF-36)	Quality of Life (0-100, where 50 is normal for geographical population. Higher score is better)	Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
Secondary	Numeric Rating Scale (NRS) Pain	Pain Score (0-10, where 10 is maximum pain, and 0 is no pain. Lower score is better)	Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
Secondary	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).	Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
Secondary	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)	Routine Clinical Care: Baseline and 3-6 Months Post-Operatively