NCT07331298

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
23mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jan 2026Apr 2028

First Submitted

Initial submission to the registry

February 25, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

2.2 years

First QC Date

February 25, 2025

Last Update Submit

December 30, 2025

Conditions

Scoliosis Idiopathic

Keywords

apparent diffusion coeficientintervertebral discscoliosischild

Outcome Measures

Primary Outcomes (1)

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

    between Day 15 and Day 90

Secondary Outcomes (3)

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

    between Day 15 and Day 90

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

    between Day 15 and Day 90

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

    between Day 15 and Day 90

Study Arms (2)

Scoliotic patients

children with spinal deformity characterized by a hump on clinical examination and a radiological deformation in the coronal plane greater than 10 ° .

Other: magnetic resonance imaging of the lumbar or spinal region

Non scoliotic patients

Childrne with no hump on clinical examination, able to walk.

Other: magnetic resonance imaging of the lumbar or spinal region

Interventions

magnetic resonance imaging of the lumbar or spinal regionOTHER

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

Non scoliotic patientsScoliotic patients

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Limoges University Hospital

Limoges, 87042, France

Location

Toulouse University Hospital

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Quentin BALLOUHEY, MD

CONTACT

+33555052410quentin.ballouhey@chu-limoges.fr

Edouard LOEVENBRUCK

CONTACT

Edouard.LOEVENBRUCK@chu-limoges.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2025

First Posted

January 9, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

January 9, 2026

Record last verified: 2025-12

Locations

FR(2)