- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07331298
Apparent Diffusion Coefficient of the Intervertebral Disc in Children: Pilot Study (CADDIE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Quentin BALLOUHEY, MD
- Phone Number: +33555052410
- Email: quentin.ballouhey@chu-limoges.fr
Study Contact Backup
- Name: Edouard LOEVENBRUCK
- Email: Edouard.LOEVENBRUCK@chu-limoges.fr
Study Locations
-
-
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Limoges, France, 87042
- Limoges University Hospital
-
Contact:
- Quentin BALLOUHEY, MD
- Phone Number: +33555052410
- Email: quentin.ballouhey@chu-limoges.fr
-
Principal Investigator:
- Quentin BALLOUHEY, MD
-
Toulouse, France, 31059
- Toulouse University Hospital
-
Principal Investigator:
- Tristan LANGLAIS, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Scoliotic patients
children with spinal deformity characterized by a hump on clinical examination and a radiological deformation in the coronal plane greater than 10 ° .
|
The duration of the acquisition sequence between 2 and 10 minutes additional compared to a conventional magnetic resonance imaging examination.
|
|
Non scoliotic patients
Childrne with no hump on clinical examination, able to walk.
|
The duration of the acquisition sequence between 2 and 10 minutes additional compared to a conventional magnetic resonance imaging examination.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
measurement of the value of Apparent Diffusion Coefficient (ADC) in magnetic resonance imaging.
Time Frame: between Day 15 and Day 90
|
between Day 15 and Day 90
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Apparent Diffusion Coefficient difference for scoliosis and non-scoliosis patients for one level
Time Frame: between Day 15 and Day 90
|
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
|
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
|
between Day 15 and Day 90
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 87RI19_0004 (CADDIE)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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