Actively Recruiting
Irradiation in Pediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention
Led by Institut Claudius Regaud · Updated on 2026-04-13
130
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying children who received brain irradiation between ages 4 and 12 for brain tumors to understand how radiation doses to the hippocampus affect memory two years after treatment. This study involves neuropsychological assessments to evaluate memory and cognitive functions over time, aiming to identify potential memory deficits linked to radiotherapy. It is a multicenter, open-label study including 130 pediatric patients and sponsored by Institut Claudius Regaud. Participants will undergo neuropsychological tests at two key points: at inclusion, which is two years after completing radiotherapy, and again two years after that. Parents will complete questionnaires about their child's cognitive abilities before and after treatment. For patients treated at the IUCT-O center, special MRI scans without contrast will be offered at inclusion and at the two-year follow-up. Radiotherapy and imaging data will also be collected using specialized software. During the study, children will have cognitive tests with a pediatric neuropsychologist involving face-to-face and telephone assessments. Parents will complete questionnaires to assess neurocognitive levels retrospectively and prospectively. Researchers will measure memory deficits using standardized tests like the Children's Memory Scale and others assessing procedural and working memory. Follow-ups will occur over a total of four years after radiotherapy, including safety monitoring and imaging evaluations.
CONDITIONS
Brief 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 localized brain irradiation or craniospinal irradiation for a brain tumor with first-line radiotherapy treatment.
- Diagnosis of ependymomas, medulloblastomas, malignant germ cell tumors, craniopharyngioma, or pinealoblastoma.
- Age between 4 and 12 years at the time of radiotherapy treatment.
- Completion of radiotherapy within 2 years (plus or minus 3 months) prior to inclusion.
- Treatment by photontherapy or proton therapy.
- Sufficient visual, auditory (with authorized hearing aid), and oral or written expression capacity for neuropsychological tests.
- Proficiency in French by the patient and parent(s).
- Affiliated to a Social Security scheme in France.
- Signed informed consent by the patient/legal parent(s)/guardian(s) according to French law and Good Clinical Practice.
You will not qualify if you...
- Severe ataxia.
- Recurrence of the disease.
- Metastatic disease (since protocol version 2).
- Contraindications to MRI for patients included in Toulouse (e.g., pacemaker, cardiac defibrillator, implanted electrical/magnetic/mechanical equipment, haemostatic clips, orthopedic implants, claustrophobia).
- Current psychostimulant or psychotropic treatment (e.g., methylphenidate, antidepressants).
- Psychological, family, geographical, or sociological conditions preventing compliance with medical monitoring or study procedures.
- Patients deprived of liberty or under legal protection.
- Severe posterior fossa syndrome with akinetic mutism.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At inclusion and 2 years after inclusion
Participants undergo neuropsychological assessments including parental questionnaires and patient cognitive tests to evaluate neurocognitive levels before and after radiotherapy treatment. For participants treated at IUCT-O, multimodal MRI scans may also be performed.
1 half-day face-to-face consultation and 1 telephone call at inclusion, repeated at 2 years; MRI scans may occur twice for some participants
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
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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