Image

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

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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.

Study details

Cervical Spondylosis With Myelopathy, Degenerative Cervical Myelopathy

NCT05242666

Cambridge University Hospitals NHS Foundation Trust

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.