Cervical Spondylosis With MyelopathyIMAGE-DCMNCT05242666

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

A study testing 3T MR Imaging of the cervical spinal cord, Positron Emission Tomography using [11C]PIB and 3T MR Imaging of the Brain in people with Cervical Spondylosis With Myelopathy and Degenerative Cervical Myelopathy, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Cervical Spondylosis With Myelopathy, Degenerative Cervical Myelopathy
What is being tested?: 3T MR Imaging of the cervical spinal cord, Positron Emission Tomography using [11C]PIB and 3T MR Imaging of the Brain
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited Kingdom
Study dates: 17 Apr 2021to 1 Feb 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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

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Intra-ocular metallic shards
Cochlear implants
Automatic cardioverter defibrillators
Nerve stimulation units
Other electronic implants, such as cardiac pacemakers
Orthopedic external fixations
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

Trial locations and contacts

1 site in 1 country.

Benjamin Davies contact

01223 254517

benjamin.davies4@nhs.net

United Kingdom1 site, 1 recruiting

Cambridge University Hospital
Cambridge, Cambridgeshire, CB2 0QQ
Benjamin Davies, benjamin.davies@addenbrookes.nhs.uk
Recruiting

Other trials in United Kingdom

About this study

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

Read the 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.

Conditions: Cervical Spondylosis With Myelopathy, Degenerative Cervical Myelopathy
Being tested: 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
Keywords: Positron Emission Tomography, Magnetic Resonance Imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3T MR Imaging of the cervical spinal cordDiagnostic test
Patients will undergo either Magnetic Resonance Imaging of the Spinal Cord
Positron Emission Tomography using [11C]PIBOther
Patients will undergo combination MRI/PET using a [11C]PIB radiotracer
3T MR Imaging of the BrainOther
3T MR Imaging of the Brain
7T MR Imaging of the Spinal CordOther
7T MR Imaging of the Spinal Cord

Study groups in NCT05242666
Study group	Role	What they receive
DCM1: MRI Spinal Cord	Other	3T MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery. Receives: Diagnostic Test: 3T MR Imaging of the cervical spinal cord
DCM2: MRI Brain and Spinal Cord	Other	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. Receives: 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
DCM3: [11C]-PIB MR/PET Cervical Spinal Cord	Other	[11C]PIB PET/MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery. Receives: Other: Positron Emission Tomography using [11C]PIB
Healthy Volunteer: MRI Brain and Spinal Cord	Other	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. Receives: Diagnostic Test: 3T MR Imaging of the cervical spinal cord; Other: 3T MR Imaging of the Brain

What is being measured

The primary outcome is the main question the study is designed to answer.

Modified Japanese Orthopaedics Association (mJOA)
Measured: 6 Months Post Surgery

Secondary outcomes (4)

Short-Form 36 (SF-36)
Quality of Life (0-100, where 50 is normal for geographical population. Higher score is better)
Measured: Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
Numeric Rating Scale (NRS) Pain
Pain Score (0-10, where 10 is maximum pain, and 0 is no pain. Lower score is better)
Measured: Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
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).
Measured: Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
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)
Measured: Routine Clinical Care: Baseline and 3-6 Months Post-Operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 20211 Feb 2025

First posted16 Feb 2022
Study start17 Apr 2021
Primary completion1 Feb 2025 (estimated)
Study completion1 Feb 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cervical Spondylosis With MyelopathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
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)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05242666
Sponsor's protocol ID: 274826
Acronym: IMAGE-DCM
Status last verified: May 2022
First submitted: 5 Dec 2019
Last updated: 27 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Annoymised Data will be made available, for collaboration, at the discretion of the senior investigators upon completion of the study.

Publications

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.
PubMed 29472200

Want to know more?

Benjamin Davies

01223 254517

benjamin.davies4@nhs.net

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Not yet recruitingObservational study
A Multicenter Registry-Based Study Across the Spectrum of Degenerative Cervical Myelopathy
Degenerative Cervical Myelopathy, Non-myelopathic Degenerative Cervical Cord Compression
Active, not recruiting
Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating Cervical Ossification of the Posterior Longitudinal Ligament
Ossification of Posterior Longitudinal Ligament, Cervical Spondylosis With Myelopathy
Active, not recruiting
Cervical Spondylotic Myelopathy Surgical Trial
Cervical Spondylosis With Myelopathy
RecruitingObservational study
Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty
Cervical Spondylosis With Myelopathy, Cervical Radiculopathy

All Cervical Spondylosis With Myelopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating Advanced Imaging Techniques for Use in the Assessment of Degenerative Cervical Myelopathy
ClinicalTrials.gov ID: NCT05242666
Acronym / sponsor ID: IMAGE-DCM / 274826
Conditions: Cervical Spondylosis With Myelopathy, Degenerative Cervical Myelopathy
Keywords: Positron Emission Tomography, Magnetic Resonance Imaging
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
Collaborators: National Institute for Health Research, United Kingdom, Wolfson Brain Imaging Centre
Study start: 17 Apr 2021 (actual)
Primary completion: 1 Feb 2025 (estimated)
Study completion: 1 Feb 2025 (estimated)
First posted: 16 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
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.

Arm	Type	Receives
DCM1: MRI Spinal Cord	Other	Diagnostic Test: 3T MR Imaging of the cervical spinal cord3T MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery.
DCM2: MRI Brain and Spinal Cord	Other	Diagnostic Test: 3T MR Imaging of the cervical spinal cord, Other: 3T MR Imaging of the Brain, Other: 7T MR Imaging of the Spinal Cord3T 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.
DCM3: [11C]-PIB MR/PET Cervical Spinal Cord	Other	Other: Positron Emission Tomography using [11C]PIB[11C]PIB PET/MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery.
Healthy Volunteer: MRI Brain and Spinal Cord	Other	Diagnostic Test: 3T MR Imaging of the cervical spinal cord, Other: 3T MR Imaging of the BrainAge-Matched Healthy Controls will undergo MRI Brain and Spinal Cord. A subset will also be invited to undergo interval imaging at 3-6 months.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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);
Participant is willing and able to give informed consent for participation in the study;

Key exclusion criteria (17 listed)

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):
In addition, the following exclusion criteria will apply for PET imaging, to reduce implications of exposure to ionising radiation, or interpretation of findings.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
3T MR Imaging of the cervical spinal cordPatients will undergo either Magnetic Resonance Imaging of the Spinal Cord	Diagnostic test	DCM1: MRI Spinal Cord, DCM2: MRI Brain and Spinal Cord, Healthy Volunteer: MRI Brain and Spinal Cord
Positron Emission Tomography using [11C]PIBPatients will undergo combination MRI/PET using a [11C]PIB radiotracer	Other	DCM3: [11C]-PIB MR/PET Cervical Spinal Cord
3T MR Imaging of the Brain3T MR Imaging of the Brain	Other	DCM2: MRI Brain and Spinal Cord, Healthy Volunteer: MRI Brain and Spinal Cord
7T MR Imaging of the Spinal Cord7T MR Imaging of the Spinal Cord	Other	DCM2: MRI Brain and Spinal Cord

Primary outcome

Modified Japanese Orthopaedics Association (mJOA)
Time frame: 6 Months Post Surgery

4 secondary outcomes

Short-Form 36 (SF-36)
Time frame: Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
Numeric Rating Scale (NRS) Pain
Time frame: Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
Myelopathy.org Symptom Inventory [MOSI]
Time frame: Routine Clinical Care: Baseline and 3-6 Months Post-Operatively
Neurological Exam
Time frame: Routine Clinical Care: Baseline and 3-6 Months Post-Operatively

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
Background: PubMed 29472200Davies BM, Mowforth OD, Smith EK, Kotter MR. Degenerative cervical myelopathy. BMJ. 2018 Feb 22;360:k186. doi: 10.1136/bmj.k186. No abstract available.
Individual participant dataSharing planned: No. Annoymised Data will be made available, for collaboration, at the discretion of the senior investigators upon completion of the study.

Related trials for Cervical Spondylosis With Myelopathy

Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Not yet recruitingObservational study
A Multicenter Registry-Based Study Across the Spectrum of Degenerative Cervical Myelopathy
Degenerative Cervical Myelopathy, Non-myelopathic Degenerative Cervical Cord Compression
Active, not recruiting
Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating Cervical Ossification of the Posterior Longitudinal Ligament
Ossification of Posterior Longitudinal Ligament, Cervical Spondylosis With Myelopathy
Active, not recruiting
Cervical Spondylotic Myelopathy Surgical Trial
Cervical Spondylosis With Myelopathy
RecruitingObservational study
Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty
Cervical Spondylosis With Myelopathy, Cervical Radiculopathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Benjamin Davies contact

01223 254517

benjamin.davies4@nhs.net

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Benjamin Davies (01223 254517, benjamin.davies4@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Japanese Orthopaedics Association (mJOA) (time frame: 6 Months Post Surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05242666, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.