Scoliosis IdiopathicCADDIENCT07331298
Apparent Diffusion Coefficient of the Intervertebral Disc in Children: Pilot Study
An observational study of Scoliosis Idiopathic, run by University Hospital, Limoges at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- magnetic resonance imaging of the lumbar or spinal region
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Jan 2026to 1 Apr 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: children and adolescents with and without scoliosis seen in consultation and requiring magnetic resonance imaging of the lumbar region
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Edouard LOEVENBRUCK contact
France2 sites, 2 recruiting
- Recruiting
Limoges University Hospital
Limoges, 87042
Quentin BALLOUHEY, MD, +33555052410, quentin.ballouhey@chu-limoges.fr
Quentin BALLOUHEY, MD
- Not yet recruiting
Toulouse University Hospital
Toulouse, 31059
Tristan LANGLAIS, MD
About this 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.
Read more
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.
- Conditions
- Scoliosis Idiopathic
- Being tested
- magnetic resonance imaging of the lumbar or spinal region
- Keywords
- apparent diffusion coeficient, intervertebral disc, scoliosis, child
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Scoliotic patients | children with spinal deformity characterized by a hump on clinical examination and a radiological deformation in the coronal plane greater than 10 ° . Receives: Other: magnetic resonance imaging of the lumbar or spinal region | |
| Non scoliotic patients | Childrne with no hump on clinical examination, able to walk. Receives: Other: magnetic resonance imaging of the lumbar or spinal region |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of the value of Apparent Diffusion Coefficient (ADC) in magnetic resonance imaging.
Measured: between Day 15 and Day 90
Secondary outcomes (3)
Apparent Diffusion Coefficient difference for scoliosis and non-scoliosis patients for one level
Measured: between Day 15 and Day 90
Correlation between right and left Apparent Diffusion Coefficient and inclination of two vertebra for scoliosis patients
Measured: between Day 15 and Day 90
gagCEST(Chemical Exchange Saturation Transfer) measurement in magnetic resonance imaging of the discs
Measured: between Day 15 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start5 Jan 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331298
- Sponsor's protocol ID
- 87RI19_0004 (CADDIE)
- Acronym
- CADDIE
- Status last verified
- Jun 2026
- First submitted
- 25 Feb 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apparent Diffusion Coefficient of the Intervertebral Disc in Children: Pilot Study
- ClinicalTrials.gov ID
- NCT07331298
- Acronym / sponsor ID
- CADDIE / 87RI19_0004 (CADDIE)
- Conditions
- Scoliosis Idiopathic
- Keywords
- apparent diffusion coeficient, intervertebral disc, scoliosis, child
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scoliotic patients | – | Other: magnetic resonance imaging of the lumbar or spinal regionchildren with spinal deformity characterized by a hump on clinical examination and a radiological deformation in the coronal plane greater than 10 ° . |
| Non scoliotic patients | – | Other: magnetic resonance imaging of the lumbar or spinal regionChildrne with no hump on clinical examination, able to walk. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children and adolescents with and without scoliosis seen in consultation and requiring magnetic resonance imaging of the lumbar region
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance imaging of the lumbar or spinal regionThe duration of the acquisition sequence between 2 and 10 minutes additional compared to a conventional magnetic resonance imaging examination. | Other | Non scoliotic patients, Scoliotic patients |
Primary outcome
measurement of the value of Apparent Diffusion Coefficient (ADC) in magnetic resonance imaging.
Time frame: between Day 15 and Day 90
3 secondary outcomes
Apparent Diffusion Coefficient difference for scoliosis and non-scoliosis patients for one level
Time frame: 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
gagCEST(Chemical Exchange Saturation Transfer) measurement in magnetic resonance imaging of the discs
Time frame: between Day 15 and Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
Related trials for Scoliosis Idiopathic
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Recruiting
Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for AIS
Adolescent Idiopathic Scoliosis (AIS)
Active, not recruitingObservational study
Construction of a Screening and Precision Intervention System for Adolescent Idiopathic Scoliosis Based on the DIERS Spinal Moiré System
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening With Momentum SpineTM
Adolescent Idiopathic Scoliosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edouard LOEVENBRUCK contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic, run by University Hospital, Limoges at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quentin BALLOUHEY, MD (+33555052410, quentin.ballouhey@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of the value of Apparent Diffusion Coefficient (ADC) in magnetic resonance imaging. (time frame: between Day 15 and Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.