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临床试验/NCT06486038
NCT06486038招募中不适用

Quatitative MRI of the Spinal Cord in Cervical Myelopathy: Assessment of Microstuctural Damage for Outcome Improvement

Istituto Clinico Humanitas2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Novel qMRI protocol clinically for the identification and quantification of microstructural Spinal Cord damage

研究概览

简要总结

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.

详细描述

Rationale Degenerative cervical myelopathy (DCM) is a common chronic disorder and the most common cause of spinal cord dysfunction in adults, potentially leading to severe functional impairment with high social costs. More than 70% of people younger than 65 years have pathologic or radiologic evidence of cervical degenerative disease. Symptoms of cervical compression develop in about 25% of these people. Consequently, identifying optimal treatment strategies and clinical care pathways for DCM has become a key public health priority. DCM is caused by a progressive deterioration of osseocartilaginous components of the cervical spine leading to a narrowing of the spinal canal and compression of the long tracts and local segmental elements of the Spinal Cord (SC). DCM can lead to progressive disability and paralysis owing to chronic SC compression.

In DCM, an early diagnosis and monitoring are pivotal to avoid or constrain a neurological damage that may persist even after appropriate treatment is provided. Diagnosis of DCM requires agreement between clinical and imaging findings (MRI).

Quantitative MRI of the SC 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.

The plan with this project is to validate a newer clinically feasible quantitative MRI protocol to depict spinal cord microstructural changes determined by degenerative cervical spine disease, that is highly frequent in the adult population. Investigators are confident that to identify quantitative MRI-derived metrics that could objectively quantify spinal cord damage in degenerative cervical myelopathy, and that could depict microstructural modifications even before neurological signs or signal alterations on morphological MRI sequences are evident. This could be of pivotal importance for more precise indication to surgery and to prevent clinically significant damage that might not be recovered even after surgical treatment. These data will be measured and validated by neurophysiological findings, and compared to current scales and ad-hoc battery of neuromotor skill assessment tests.

Clinical, neurophysiological, biometric and imaging follow-up will be performed to assess the predictive power of the identified metrics.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects willing and able to give informed consent for participation in the study.
  • Subjects under evaluation for potential surgical intervention of anterior cervical discectomy and fusion as established by a board-certified neurosurgeon based on clinical and radiological findings according to good clinical practice.
  • Grade I-III single level sub-axial (C3-C7) cervical spinal canal stenosis (Kang, AJR 2011) on a preliminary anatomical MRI.
  • Deficitary or irritative cervical spinal cord symptoms and/or signs in concordance with MRI findings.

排除标准

  • Subjects unable o.r unwilling to give informed consent .
  • Age <18 or > 80
  • Subjects with pacemaker or any other contraindication to undergo high-field (3 Tesla) MRI exam.
  • Pregnancy or planned pregnancy before the end of the study .
  • Co-existing or prior neurological disease of the brain, SC, or peripheral nervous system.
  • Co-existing or prior oncologic disease .
  • Prior surgery in the brain or spine.

结局指标

主要结局

Novel qMRI protocol clinically for the identification and quantification of microstructural Spinal Cord damage

时间窗: from baseline until the second follow up (around 6 months)

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.

次要结局

  • Integrated diagnostic tool(from month 3 to month 13)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (2)

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