Status:
RECRUITING
Irradiation in Paediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Brain Tumor, Pediatric
Eligibility:
All Genders
6-14 years
Phase:
NA
Brief Summary
This is a prospective, open-label, multicentric study designed to correlate the dose delivered to the hippocampus with declarative memory deficits 2 years after radiotherapy treatment in a paediatric ...
Eligibility Criteria
Inclusion
- Patient who has received localised brain irradiation or craniospinal irradiation for a brain tumour whose treatment includes first-line radiotherapy.
- Patient with one of the following tumour types: ependymomas, medulloblastomas, malignant germ cell tumours, craniopharyngioma, pinealoblastoma.
- Patient aged between 4 and 12 years at the time of radiotherapy treatment.
- End of irradiation within 2 years (+/-3 months) prior to inclusion.
- Patient having been treated by photontherapy or proton therapy.
- Sufficient visual, auditory (with authorised hearing aid) and oral or written expression capacity to carry out the neuropsychological tests properly.
- Proficiency in the French language by the patient and parent(s).
- Patient affiliated to a Social Security scheme in France.
- Informed consent signed by the patient/legal parent(s)/guardian(s) in accordance with French law and Good Clinical Practice.
Exclusion
- Patient presenting with severe ataxia.
- Patient with a recurrence of the disease.
- Not applicable since protocol version 2. Metastatic patient.
- Any contraindication to MRI for patients included in Toulouse (i.e. in particular patients with a pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, patients with haemostatic clips on intracerebral aneurysms, patients with orthopaedic implants, claustrophobic patients).
- Patients undergoing psychostimulant or psychotropic treatment (in particular methylphenidate, antidepressants).
- Any psychological, family, geographical or sociological condition that prevents compliance with medical monitoring and/or the procedures set out in the study protocol.
- Patients deprived of their liberty or under legal protection.
- Severe posterior fossa syndrome with akinetic mutism.
Key Trial Info
Start Date :
October 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06599879
Start Date
October 21 2025
End Date
October 1 2030
Last Update
November 18 2025
Active Locations (17)
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1
CHU Angers
Angers, France
2
CHU de Bordeaux
Bordeaux, France
3
Centre François Baclesse
Caen, France
4
Centre Georges François Leclerc
Dijon, France