Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-27 @ 2:27 AM
Study NCT ID:
NCT05242666
Status:
UNKNOWN
Last Update Posted:
2022-05-27
First Post:
2019-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantiative MRI and Myelin-PET for the Assessment of Degenerative Cervical Myelopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C475519', 'term': "2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole"}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Observational study of patients undergoing surgery for degenerative cervical myelopathy, allocated to receive an additional form of imaging assessment before and after surgery.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-26', 'studyFirstSubmitDate': '2019-12-05', 'studyFirstSubmitQcDate': '2022-02-14', 'lastUpdatePostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Japanese Orthopaedics Association (mJOA)', 'timeFrame': '6 Months Post Surgery'}], 'secondaryOutcomes': [{'measure': 'Short-Form 36 (SF-36)', 'timeFrame': 'Routine Clinical Care: Baseline and 3-6 Months Post-Operatively', 'description': 'Quality of Life (0-100, where 50 is normal for geographical population. Higher score is better)'}, {'measure': 'Numeric Rating Scale (NRS) Pain', 'timeFrame': 'Routine Clinical Care: Baseline and 3-6 Months Post-Operatively', 'description': 'Pain Score (0-10, where 10 is maximum pain, and 0 is no pain. Lower score is better)'}, {'measure': 'Myelopathy.org Symptom Inventory [MOSI]', 'timeFrame': 'Routine Clinical Care: Baseline and 3-6 Months Post-Operatively', '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).'}, {'measure': 'Neurological Exam', 'timeFrame': 'Routine Clinical Care: Baseline and 3-6 Months Post-Operatively', '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)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Positron Emission Tomography', 'Magnetic Resonance Imaging'], 'conditions': ['Cervical Spondylosis With Myelopathy', 'Degenerative Cervical Myelopathy']}, 'referencesModule': {'references': [{'pmid': '29472200', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSurgery 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.\n\nImaging 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:\n\n1. Advanced magnetic resonance imaging (MRI) to image within the spinal cord\n2. Advanced MRI to measure the changes that occur within the brain following DCM\n3. Positron Emission Tomography (PET) to measure the active disease biology within the spinal cord.\n\nIndividuals 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Participant has a diagnosis of DCM, based on a combination of symptoms, signs and conventional MRI findings (Table 2)\n2. Participant is scheduled for surgical treatment for DCM\n3. Participant is willing and able to give informed consent for participation in the study;\n4. Male or Female, aged 18 - 85 years (inclusive);\n\nExclusion Criteria\n\nThe participant may not enter the study if ANY of the following apply:\n\n1. Participant unable to give informed consent;\n2. Participant unable to undergo, or intolerant of MR or PET/MR imaging\n3. 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.\n4. 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):\n\n * Cerebral aneurysm clips not known to be MR safe\n * Intra-ocular metallic shards\n * Cochlear implants\n * Automatic cardioverter defibrillators\n * Nerve stimulation units\n * Other electronic implants, such as cardiac pacemakers\n * Orthopedic external fixations\n\nExclusion Criteria Specific for PET/MR Imaging Stream\n\nIn addition, the following exclusion criteria will apply for PET imaging, to reduce implications of exposure to ionising radiation, or interpretation of findings.\n\n1. Female patients who are pregnant or breast-feeding\n2. Participants whose DCM surgery will include the insertion of metallic implants to secure multiple levels of the spine (technically termed 'instrumentation')\n3. Age \\<40\n\n4.3.2 Volunteers\n\nInclusion Criteria\n\n1. Participant is willing and able to give informed consent for participation in the study;\n2. Male or Female, aged 18 - 85 years (inclusive); Exclusion Criteria\n\nThe participant may not enter the study if ANY of the following apply:\n\n1. Participant unable to give informed consent;\n2. Participant unable to undergo, or intolerant of MR imaging\n3. 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."}, 'identificationModule': {'nctId': 'NCT05242666', 'acronym': 'IMAGE-DCM', 'briefTitle': 'Quantiative MRI and Myelin-PET for the Assessment of Degenerative Cervical Myelopathy', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Evaluating Advanced Imaging Techniques for Use in the Assessment of Degenerative Cervical Myelopathy', 'orgStudyIdInfo': {'id': '274826'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DCM1: MRI Spinal Cord', 'description': '3T MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery.', 'interventionNames': ['Diagnostic Test: 3T MR Imaging of the cervical spinal cord']}, {'type': 'OTHER', 'label': 'DCM2: MRI Brain and Spinal Cord', '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.', 'interventionNames': ['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']}, {'type': 'OTHER', 'label': 'DCM3: [11C]-PIB MR/PET Cervical Spinal Cord', 'description': '\\[11C\\]PIB PET/MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery.', 'interventionNames': ['Other: Positron Emission Tomography using [11C]PIB']}, {'type': 'OTHER', 'label': 'Healthy Volunteer: MRI Brain and Spinal Cord', '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.', 'interventionNames': ['Diagnostic Test: 3T MR Imaging of the cervical spinal cord', 'Other: 3T MR Imaging of the Brain']}], 'interventions': [{'name': '3T MR Imaging of the cervical spinal cord', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will undergo either Magnetic Resonance Imaging of the Spinal Cord', 'armGroupLabels': ['DCM1: MRI Spinal Cord', 'DCM2: MRI Brain and Spinal Cord', 'Healthy Volunteer: MRI Brain and Spinal Cord']}, {'name': 'Positron Emission Tomography using [11C]PIB', 'type': 'OTHER', 'description': 'Patients will undergo combination MRI/PET using a \\[11C\\]PIB radiotracer', 'armGroupLabels': ['DCM3: [11C]-PIB MR/PET Cervical Spinal Cord']}, {'name': '3T MR Imaging of the Brain', 'type': 'OTHER', 'description': '3T MR Imaging of the Brain', 'armGroupLabels': ['DCM2: MRI Brain and Spinal Cord', 'Healthy Volunteer: MRI Brain and Spinal Cord']}, {'name': '7T MR Imaging of the Spinal Cord', 'type': 'OTHER', 'description': '7T MR Imaging of the Spinal Cord', 'armGroupLabels': ['DCM2: MRI Brain and Spinal Cord']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Benjamin Davies', 'role': 'CONTACT', 'email': 'benjamin.davies@addenbrookes.nhs.uk'}], 'facility': 'Cambridge University Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'centralContacts': [{'name': 'Benjamin Davies', 'role': 'CONTACT', 'email': 'benjamin.davies4@nhs.net', 'phone': '01223 254517'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Annoymised Data will be made available, for collaboration, at the discretion of the senior investigators upon completion of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}, {'name': 'Wolfson Brain Imaging Centre', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Honorary Specialist Registrar, Department of Neurosurgery, Cambridge University Hospital', 'investigatorFullName': 'Benjamin Davies', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}