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NCT Number: NCT07331298

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

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.

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Key information

Conditions

Scoliosis Idiopathic Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Limoges University Hospital, Limoges, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

magnetic resonance imaging of the lumbar or spinal region

Other

The duration of the acquisition sequence between 2 and 10 minutes additional compared to a conventional magnetic resonance imaging examination.

Primary outcomes

  1. measurement of the value of Apparent Diffusion Coefficient (ADC) in magnetic resonance imaging.

    Time frame: between Day 15 and Day 90

Secondary outcomes

  1. Apparent Diffusion Coefficient difference for scoliosis and non-scoliosis patients for one level

    Time frame: between Day 15 and Day 90

  2. Correlation between right and left Apparent Diffusion Coefficient and inclination of two vertebra for scoliosis patients

    Time frame: between Day 15 and Day 90

  3. gagCEST(Chemical Exchange Saturation Transfer) measurement in magnetic resonance imaging of the discs

    Time frame: between Day 15 and Day 90

Study contacts

Contact information is provided by the study sponsor or research team.

Edouard LOEVENBRUCK

CONTACT

[email protected]

Quentin BALLOUHEY, MD

CONTACT

[email protected]

+33555052410

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: CADDIE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 9, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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