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Recruiting NCT07331298

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

Observational Scoliosis Idiopathic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: magnetic resonance imaging of the lumbar or spinal region.
Who it may be relevant to
Registry conditions: Scoliosis Idiopathic. Basic parameters: 8 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • measurement of the value of Apparent Diffusion Coefficient (ADC) in magnetic resonance imaging. [Time frame: between Day 15 and Day 90]
Secondary outcome measures (3)
  • Apparent Diffusion Coefficient difference for scoliosis and non-scoliosis patients for one level [Time frame: between Day 15 and Day 90]
  • Correlation between right and left Apparent Diffusion Coefficient and inclination of two vertebra for scoliosis patients [Time frame: between Day 15 and Day 90]
  • gagCEST(Chemical Exchange Saturation Transfer) measurement in magnetic resonance imaging of the discs [Time frame: between Day 15 and Day 90]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 2 centers
  • Limoges University Hospital — Limoges
  • Toulouse University Hospital — Toulouse

Identifiers

NCT: NCT07331298 · 87RI19_0004 (CADDIE)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗