Quantitative Imaging of Cervical Spinal Structures in Healthy Participants and Patients With Cervical Degenerative Disc Disease - the DISC Pilot Study -
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical correlation of quantitative MRI sequences and clinical impairment in patients with symptomatic CDDD
研究概览
简要总结
The aim of this study is to explore a multi-parametric quantitative MRI approach to measure cervical intervertebral discs, the spinal cord and its nerve roots in healthy participants and patients with cervical degenerative disc disease (CDDD).
CDDD is the consequence of degeneration of intervertebral discs and joints leading to symptoms of cervical radiculopathy, myelopathy, or a combination of both. The incidence of symptomatic CDDD is rising with the aging population, and, consequently, a significant increase in surgeries for symptomatic CDDD is predicted in the upcoming years. However, the decision for- and optimal timing of surgery remain challenging.
Currently, the decision for surgery in patients with symptomatic CDDD is related to symptoms, as well as position and size of disc herniation on conventional Magnetic Resonance Imaging (MRI). However, conventional MRI only enables qualitative morphological evaluation, leaving space for subjective individual interpretation. Also, disc herniations on conventional MRI are frequently found in asymptomatic individuals, while, in symptomatic individuals type and extent of disc herniation does not correlate to severity of symptoms. Altogether, the current standard using conventional MRI cannot optimally predict response to surgery for patients with symptomatic CDDD.
The primary aim of this project is to investigate whether a combination of different quantitative imaging sequences can provide more detailed information on disc herniation related compression and potentially aid in determining more objective cut-offs to stage disc herniation in patients with symptomatic CDDD, as well as to analyze whether differences exist in quantitative imaging parameters of discs in healthy participants versus patients with symptomatic CDDD. These novel techniques are promising, as they are noninvasive and could potentially aid in determining objective cut-offs to stage disc herniation. Since no single measurement has been proven to be the golden standard in previous studies, it is likely that a combination of measurements is needed for clinical application
详细描述
RATIONALE:
Cervical degenerative disc disease (CDDD) is the consequence of degeneration of intervertebral discs and joints and can result in compression of the cervical nerve root leading to clinical symptoms of radiculopathy, compression of the spinal cord with symptoms of myelopathy, or a combination of both.The incidence of CDDD is rising with the aging population, and, consequently, a significant increase insurgeries for symptomatic CDDD is predicted in the upcoming years. As such, the decision for- and optimal timing of surgery remain challenging.
Currently, the decision for surgery in patients with symptomatic CDDD is related to symptoms, as well as position and size of disc herniation on conventional Magnetic Resonance Imaging (MRI). However, conventional MRI only enables qualitative morphological evaluation, leaving space for subjective individual interpretation. Also, disc herniations on conventional MRI are frequently found in asymptomatic individuals, while, in symptomatic individuals type and extent of disc herniation does not correlate to severity of symptoms. Altogether, the current standard using conventional MRI cannot optimally predict response to surgery for patients with symptomatic CDDD.
Quantitative imaging is rapidly being recognized as a supplement to conventional MRI and refers to the direct measurement of physical properties of tissue. These novel techniques are promising, as they are noninvasive and could potentially aid in determining objective cut-offs to stage disc herniation. Diffusion tensor imaging (DTI) is one of the most studied quantitative techniques and allows for evaluation of microstructural changes. The DTI fractional anisotropy (FA) metric was demonstrated as valid biomarker for recovery after surgery in cervical myelopathy as well as surgical selection in lumbar radiculopathy. Moreover, recent introduction of zoomed-DTI (z-DTI) could lead to greater imaging accuracy while proven feasible in the cervical spine.
Furthermore, the cervical spinal cord and its nerve roots are highly vascularized and their perfusion could be compromised by disc-herniation related compression. Using the endogenous perfusion technique arterial spin labeling (ASL), as well as contrast-based perfusion techniques such as susceptibility contrast (DSC) and dynamic contrast enhanced (DCE), degree of ischemia, hypoxia as well as signal enhancement can be estimated. ASL has been studied twice for spinal cord perfusion mapping and DSC was demonstrated feasible in the spine of healthy participants as well as patients with cervical myelopathy. Additionally, increased signal enhancement was observed for DCE in degenerative discs of the lumbar spine. To our best knowledge, no studies have been conducted to assess perfusion of the cervical nerve roots, which are compromised in cervical radiculopathy due to CDDD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with symptomatic CDDD
- •Age ≥18 years
- •One-level or 2-level symptomatic CDDD (radiculopathy, myelopathy or radiculomyelopathy) of cervical levels C4-5, C5-6l, C6-7 or C7-Th
- •Sufficient understanding of spoken and written Dutch language
- •Agrees to participate in the obligatory measurements of this study and signed informed consent prior to any study-related procedures.
- •Women who use anticonception or are in their menopause. If this is not the case, a negative pregnancy test is necessary.
- •Healthy participants
- •Age-matched healthy participant.
- •Sufficient understanding of spoken and written Dutch language.
- •Agrees to participate in the obligatory measurements of this study and signed informed consent prior to any study-related procedures.
- •Women who use anticonception or are in their menopause. If this is not the case, a negative pregnancy test is necessary
排除标准
- •Patients with symptomatic CDDD
- •Multi-segmental (3 or more segments) symptomatic CDDD.
- •Contraindication for an MRI scan (e.g. implanted non-MRI-compatible devices or foreign bodies, claustrophobic or pregnancy).
- •A positive pregnancy test.
- •Allergy for contrast medium.
- •Previous history of cervical spine surgery.
- •Healthy participants
- •Contraindication for an MRI scan (e.g. implanted non-MRI-compatible devices or foreign bodies, claustrophobic or pregnancy).
- •A positive pregnancy test.
- •Allergy for contrast medium.
- •Previous history of cervical spine surgery.
- •Complaints of symptomatic CDDD (radiating arm/neck pain, tingling fingers, loss of strength or changed sensibility in one of the upper extremities).
结局指标
主要结局
Clinical correlation of quantitative MRI sequences and clinical impairment in patients with symptomatic CDDD
时间窗: MRI and clinical examinations conducted at study visit (baseline)
To determine a correlation of quantitative MRI sequences of cervical spinal structures to clinical impairment in patients with symptomatic CDDD. Clinical impairment will be measured with the Neck Disability Index (NDI) for cervical radiculopathy, modified Japanese Orthopaedic Association Score (mJOA) for cervical myelopathy, and NDI as well as mJOA for cervical radiculomyelopathy.
To determine a correlation between baseline quantitative MRI sequences of cervical spinal structures and surgical treatment after 6 months of follow-up in patients with symptomatic CDDD as well as clinical outcomes assessed at 6 months of follow-up.
时间窗: 6 months
Comparison CSI
时间窗: During first study visit
To make a comparison of the CSI-score in healthy participants with bulging discs on MRI compared to patients with symptomatic CDDD.
Quantitative MRI sequences
时间窗: MRI conducted at study visit (baseline)
Technical feasibility and repeatibility of quantitative MRI sequences (i.e. z-DTI, ASL, DSC, DCE, SyMRI, and TMRE) of cervical spinal structures (i.e. intervertebral disc, spinal cord, and nerve roots) in healthy participants and patients with symptomatic CDDD.
次要结局
- Correlation between quantitative MRI sequences of the cervical spinal cord with extent of compression on anatomical MRI (cross-sectional area spinal cord) in healthy participants and patients with symptomatic CDDD.(Comparison made at baseline and for patients with symptomatic CDDD also at 6 months follow-up)
- Between-group analyses comparing quantitative MRI sequences of cervical spinal structures of healthy participants to subgroups of patients(MRI conducted at baseline and at 6 months follow-up in the patients with symptomatic CDDD)
- Comparison of quantitative MRI sequences of cervical spinal structures in healthy participants and patients with symptomatic CDDD to available values in literature.(Assessed during study visit)
- To determine a correlation of quantitative MRI sequences of cervical spinal structures to clinical outcomes(MRI conducted at baseline and at 6 months follow-up in the patients with symptomatic CDDD)