Apparent Diffusion Coefficient of the Intervertebral Disc in Children: Pilot Study

Обзор

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.

Вмешательства

• Другое magnetic resonance imaging of the lumbar or spinal region
  The duration of the acquisition sequence between 2 and 10 minutes additional compared to a conventional magnetic resonance imaging examination.

Первичные конечные точки

• measurement of the value of Apparent Diffusion Coefficient (ADC) in magnetic resonance imaging. [Срок оценки: between Day 15 and Day 90]

Вторичные конечные точки (3)

• Apparent Diffusion Coefficient difference for scoliosis and non-scoliosis patients for one level [Срок оценки: between Day 15 and Day 90]
• Correlation between right and left Apparent Diffusion Coefficient and inclination of two vertebra for scoliosis patients [Срок оценки: between Day 15 and Day 90]
• gagCEST(Chemical Exchange Saturation Transfer) measurement in magnetic resonance imaging of the discs [Срок оценки: between Day 15 and Day 90]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 2 центра

• Limoges University Hospital — Limoges
• Toulouse University Hospital — Toulouse

Идентификаторы

NCT: NCT07331298 · 87RI19_0004 (CADDIE)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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