Apparent Diffusion Coefficient of the Intervertebral Disc in Children: Pilot Study
ConditionScoliosis Idiopathic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-16
SponsorUniversity Hospital, Limoges
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
children and adolescents with and without scoliosis seen in consultation and requiring magnetic resonance imaging of the lumbar region
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
magnetic resonance imaging of the lumbar or spinal region
Other interventionThe duration of the acquisition sequence between 2 and 10 minutes additional compared to a conventional magnetic resonance imaging examination.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Scoliotic patients1 intervention
Group B: Non scoliotic patients1 intervention
Trial outcomes
Primary outcomes
1
measurement of the value of Apparent Diffusion Coefficient (ADC) in magnetic resonance imaging.
Time frame
between Day 15 and Day 90Secondary outcomes
1
Apparent Diffusion Coefficient difference for scoliosis and non-scoliosis patients for one level
Time frame
between Day 15 and Day 902
Correlation between right and left Apparent Diffusion Coefficient and inclination of two vertebra for scoliosis patients
Time frame
between Day 15 and Day 903
gagCEST(Chemical Exchange Saturation Transfer) measurement in magnetic resonance imaging of the discs
Time frame
between Day 15 and Day 90Sponsors and contacts
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Source ClinicalTrials.gov