Quatitative MRI of the Spinal Cord in Cervical Myelopathy: Assessment of Microstuctural Damage for Outcome Improvement
NCT Number: NCT06486038
Acronym: QCEMY
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cervical Myelopathy
Interventions: DIAGNOSTIC_TEST: MRI standard and qMRI|OTHER: MEPs and SSEPs|OTHER: Neuromotor assessment|PROCEDURE: Anterior cervical discectomy and fusion
Sponsor: Istituto Clinico Humanitas
Collaborators: Mediolanum Cardio Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-04-03
Completion Date: 2025-05-31
Locations: IRCCS Istituto Clinico Humanitas, Rozzano, 20089, Italy

Summary:
The aim of this low interventional study is to detect microstructural degeneration prior to the presentation, worsening, or persistence following surgical or conservative treatment of cervical degenerative myelopathy signs and symptoms using quantitative imaging metrics and functional biometric analysis.

The endpoints of the study are to collect and compare the clinical, biometric, neurophysiological and imaging data.

The objectives of the study are:

* to implement and validate a novel quantitative Magnetic Resonance (qMRI) protocol clinically for the identification and quantification of microstructural spinal cord damage
* to compare qMRI data to clinical and neuromotor's and corresponding neurophysiological data
* to create an integrated diagnostic tool for early diagnosis and disease monitoring of myelopathy, and for identification of a more reproducible and quantitative scale for assessing reversible and irreversible spinal cord damage combining clinical, biometric, imaging and neurophysiological data in patients suitable for surgical or non-surgical treatment.

Patient will undergo:

* MRI (baseline - 1 month- 6 months)
* clinical data collection (baseline- 1 month - 6 months)
* neuromotor assessment (baseline - 1 month - 6 months)
* neurophysiological assessment (baseline - 6 months)
* surgery if applicable Quantitative MRI of the spinal cord could provide a new objective system for identification of patients who require surgery before developing irreversible clinical damage, and to avoid surgical treatment in those who do not require it. Additionally, quantitative MRI, in combination with clinical data such as, neuromotor tests, could provide an important approach to assess the effectiveness of the therapeutical approach.

Primary Outcome Measures: Novel qMRI protocol clinically for the identification and quantification of microstructural Spinal Cord damage, A preliminary non-contrast cervical spine MRI including morphological and quantitative sequences on a 3 Tesla scanner:

* 2D Sagittal T2-w turbo spin-echo (TSE)
* 2D Sagittal T2-w TSE with short tau inversion recovery (STIR)
* 3D Sagittal T1-w MP-RAGE with 1x1x1mm3 resolution
* 2D Transversal T2\*-w MEDIC gradient echo
* 2D Transversal Phase Sensitive Inversion Recovery (PSIR) (0.7x0.7x6.0mm3)
* 2D Transversal IR TrueFISP sampling 23 different inversion times (TI-scout, 1.0.1.0x10.0mm3)
* 2D Transversal reduced-FOV ZOOM-EPI spin-echo DTI (180x53mm2 FOV, 5 slices, b=800 s/mm2, 21 directions, 5 interspersed b=0s/mm2 volumes, 0.9x0.9x6.0mm3) with pulse trigger PSIR, TI-scout and DTI sequences will be set perpendicularly to the cord.

Acquisition of single-slice images at the level of three consecutive intervertebral discs, with the middle one corresponding to the lesion. An image-processing pipeline embedded in a XNAT system will process images., from baseline until the second follow up (around 6 months)
Secondary Outcome Measures: Integrated diagnostic tool, Through an artificial intelligence approach, clinical, biometric, neurophysiological and imaging data assessed at 1 month and 6 months follow-up in patients who underwent either surgical or non-surgical treatment will be combined in order to obtain an enhanced integrated diagnostic powerful tool for early diagnosis and disease monitoring od myelopathy, and for identification of a more reproducible and quantitative scale for assessing reversible and irreversible spinal cord damage., from month 3 to month 13