Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-01 @ 8:31 AM
Study NCT ID:
NCT06094166
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitative MR Parameters in Non-myelopathic Degenerative Cervical Spinal Cord Compression: a Longitudinal Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-16', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-10-16', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anatomical MRI metrics', 'timeFrame': '45 minutes', 'description': 'compressive ratio (CR)'}, {'measure': 'Anatomical MRI metrics', 'timeFrame': '45 minutes', 'description': 'cross-sectional area (CSA)'}, {'measure': 'dMRI: signs of microstructural myelopathy', 'timeFrame': '45 minutes', 'description': 'fractional anisotropy'}, {'measure': 'MRS: signs of metabolic myelopathy (above the level of compression)', 'timeFrame': '45 minutes', 'description': 'Myo-ins/NAA ratio'}, {'measure': 'Voxel-based MRI volumetry (remote spinal cord atrophy above the compression level)', 'timeFrame': '45 minutes', 'description': 'remote cervical cord atrophy'}], 'secondaryOutcomes': [{'measure': 'IVIM and T2*WM/GM signal-intensity ratio', 'timeFrame': '45 minutes', 'description': 'Intravoxel incoherent motion detection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Degenerative Cervical Spinal Myelopathy', 'Cervical Spinal Cord Compression']}, 'descriptionModule': {'briefSummary': 'Quantitative Magnetic Resonance Imaging Parameters as Predictors of Outcome for Non-Myelopathic Degenerative Cervical Cord Compression: A Longitudinal Study', 'detailedDescription': 'The study uses semi-automated detection of anatomical metrics (morphometric parameters) and DCC with Spinal Cord Toolbox (SCT). This method have been proven more reliable than expert\'s manual rating, the introduction of the automated method will be utilized in the future multi-centre and longitudinal studies. Routine anatomical morphometric parameters such as compressive ratio (CR) and cross-sectional area (CSA) will be acquired along with microstructural and metabolic metrics obtained with validated dMRI and MRS methods, remote cervical cord atrophy from voxel-based MRI volumetry, T2\\* white matter/gray matter (WM/GM) signal-intensity ratio, and also metrics obtained with novel Intravoxel Incoherent Motion (IVIM) method will predict progression of NMDCC into symptomatic DCM. "Natural course" (i.e., speed of progression) of the severity of DCC assessed with anatomical and advanced MRI/MRS metrics is not known but may play a role in the progression from NMDCC to symptomatic DCM. Aims of this project are: To determine independent predictors of unfavourable outcome - progression into symptomatic degenerative cervical myelopathy (DCM) - among quantitative MRI parameters and compare them with already defined clinical and electrophysiological predictors. To evaluate the "natural course" of MRI descriptors of compression and its severity, and the correlation between progression and development of symptomatic DCM. To implement automated detection of cervical cord compression using Spinal Cord Toolbox based on automatically computed morphometric parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy controls and patients with non-myelopathic cervical spinal cord compression (NMDC)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubject with no contraindication to MR examination. Clinically asymptomatic cervical spinal cord compression or subjects with no spinal cord compression.\n\nExclusion Criteria:\n\n* A subject will be excluded if he/she has a contraindication to MR scanning implanted metal clips or wires of the type which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field.\n* Pregnancy\n* Claustrophobia'}, 'identificationModule': {'nctId': 'NCT06094166', 'acronym': 'NOLOST', 'briefTitle': 'Quantitative MR Parameters in Non-myelopathic Degenerative Cervical Spinal Cord Compression: a Longitudinal Study.', 'organization': {'class': 'OTHER', 'fullName': 'Masaryk University'}, 'officialTitle': 'Quantitative Magnetic Resonance Imaging Parameters as Predictors of Outcome for Non-Myelopathic Degenerative Cervical Cord Compression: A Longitudinal Study', 'orgStudyIdInfo': {'id': '66138'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NMDCC', 'description': 'non-myelopathic cervical spinal cord compression', 'interventionNames': ['Diagnostic Test: MRI']}, {'label': 'healthy controls', 'description': 'subjects with no MR signs of cervical spinal cord compression', 'interventionNames': ['Diagnostic Test: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Quantitative imaging MR parameters', 'armGroupLabels': ['NMDCC', 'healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brno', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Tomas Horak, MD', 'role': 'CONTACT', 'email': 'tomas.horak@fnbrno.cz', 'phone': '+420724273734'}], 'facility': 'Faculty of Medicine, Masaryk University, Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'centralContacts': [{'name': 'Tomas Horak, MD. PhD.', 'role': 'CONTACT', 'email': 'horak.tomas@fnbrno.cz', 'phone': '+420724273734'}], 'overallOfficials': [{'name': 'Josef Bednarik, Prof. MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masaryk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masaryk University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Palacky University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof. MUDr. Josef Bednarik, CSc., FCMA, FEAN', 'investigatorFullName': 'Tomáš Horák', 'investigatorAffiliation': 'Masaryk University'}}}}