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

December 30, 2025 updated by: University Hospital, Limoges

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

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Limoges, France, 87042
        • Limoges University Hospital
        • Contact:
        • Principal Investigator:
          • Quentin BALLOUHEY, MD
      • Toulouse, France, 31059
        • Toulouse University Hospital
        • Principal Investigator:
          • Tristan LANGLAIS, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

children and adolescents with and without scoliosis seen in consultation and requiring magnetic resonance imaging of the lumbar region

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 5, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 87RI19_0004 (CADDIE)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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