Apparent Diffusion Coefficient of the Intervertebral Disc in Children: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- measurement of the value of Apparent Diffusion Coefficient (ADC) in magnetic resonance imaging.
研究概览
简要总结
The pathophysiology of adolescent idiopathic scoliosis is unknown. This pathology develops from 10-11 years of age and progresses until skeletal maturity, or even adulthood for the most severe forms.
Current knowledge is limited as to its origin on the one hand and the evolutionary nature of scoliosis on the other.
The mechanical parameters of the intervertebral disc are incompletely known from the deep location of this organ, its fragile nature in vivo and its susceptibility to desiccation during ex-vivo analysis.
To complete our knowledge of the mechanical parameters of the intervertebral disc of scoliotic and non-scoliotic children, we are proposing an in vivo, non-invasive and non-irradiating study carried out in children who are the main target of this pathology.
The objective of this work is to characterize the diffusion parameters (apparent diffusion coefficient ADC) of the intervertebral disc in vivo, in a non-invasive and non-irradiating manner by magnetic resonance imaging in children and adolescents. As this measurement has not been carried out in children and adolescents, we want to perform these MRI scans in children free from scoliosis and carriers of scoliosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: patients between 8 and 16 years old
- •Children undergoing magnetic resonance imaging of the lumbar or spinal region as part of their routine care
- •Scoliotic: spinal deformity characterized by a hump on clinical examination and a radiological deformation in the coronal plane greater than 10 ° with no etiology found (idiopathic)
- •Healthy: no hump on clinical examination, walking patients (level 1 and 2 of the global motor function classification system)
排除标准
- •existence of medullary and vertebral pathology other than scoliosis, history of disc or vertebral infection (spondylo-discitis) on examination, neuro-ectodermal pathology
- •behavioral disturbances incompatible with the performance of the magnetic resonance imaging examination.
- •Refusal of participation.
- •Thoracic scoliosis
研究组 & 干预措施
Scoliotic patients
children with spinal deformity characterized by a hump on clinical examination and a radiological deformation in the coronal plane greater than 10 ° .
干预措施: magnetic resonance imaging of the lumbar or spinal region (Other)
Non scoliotic patients
Childrne with no hump on clinical examination, able to walk.
干预措施: magnetic resonance imaging of the lumbar or spinal region (Other)
结局指标
主要结局
measurement of the value of Apparent Diffusion Coefficient (ADC) in magnetic resonance imaging.
时间窗: between Day 15 and Day 90
次要结局
- Apparent Diffusion Coefficient difference for scoliosis and non-scoliosis patients for one level(between Day 15 and Day 90)
- Correlation between right and left Apparent Diffusion Coefficient and inclination of two vertebra for scoliosis patients(between Day 15 and Day 90)
- gagCEST(Chemical Exchange Saturation Transfer) measurement in magnetic resonance imaging of the discs(between Day 15 and Day 90)