Actively Recruiting
Irradiation in Paediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention
Led by Institut Claudius Regaud · Updated on 2026-04-13
130
Participants Needed
15
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 population who had received brain irradiation between the ages of 4 and 12 for a brain tumour. In order to meet this objective, several neuropsychological assessments consisting of parental questionnaires and cognitive tests will be carried out during the course of the study, at the following two stages: * A 1st assessment at patient inclusion, i.e. 2 years after the end of radiotherapy treatment, * And a second assessment 2 years after patient inclusion, i.e. 4 years after the end of radiotherapy treatment. A retrospective assessment of the patient's neurocognitive level 1 year before the diagnosis of the disease will also be carried out at inclusion, with the parents completing a questionnaire specifically designed for the trial. In addition, patients who have received their radiotherapy treatment at the IUCT-O will be offered participation in the ancillary imaging study. If the parents and the patient agree, multimodal MRI scans specific to the study (without injection of contrast) will be performed at inclusion and 2 years after inclusion. Imaging and radiotherapy data will be collected in parallel using the PediaRT software used in current practice (collection of radiotherapy dosimetric data as well as standard MRI examinations pre-operatively, post-operatively, and at the 2-year and 4-year follow-up). 130 patients will be included in this study.
CONDITIONS
Official Title
Irradiation in Paediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 15 locations
1
CHU Angers
Angers, France
Actively Recruiting
2
CHU de Bordeaux
Bordeaux, France
Actively Recruiting
3
Centre François Baclesse
Caen, France
Actively Recruiting
4
Centre Georges François Leclerc
Dijon, France
Not Yet Recruiting
5
Centre Oscar Lambret
Lille, France
Not Yet Recruiting
6
Centre Léon Bérard
Lyon, France
Actively Recruiting
7
APHM - Hôpital la Timone
Marseille, France
Not Yet Recruiting
8
Institut du Cancer de Montpellier
Montpellier, France
Not Yet Recruiting
9
Institut Curie
Paris, France
Not Yet Recruiting
10
Centre Eugène Marquis
Rennes, France
Not Yet Recruiting
11
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Not Yet Recruiting
12
Centre Paul Strauss
Strasbourg, France
Actively Recruiting
13
IUCT-O
Toulouse, France
Actively Recruiting
14
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Actively Recruiting
15
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
A
Anne LAPRIE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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