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Irradiation in Paediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention
Sponsor: Institut Claudius Regaud
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 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.
Key Details
Gender
All
Age Range
6 Years - 14 Years
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2025-10-21
Completion Date
2030-10
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Neuropsychological assessments:
Several neuropsychological assessments were carried out during the study (at inclusion and 2 years after inclusion), consisting of : * parental questionnaires (standard questionnaires and questionnaires specifically drawn up for the trial). The aim of these questionnaires will be to assess the patient's neurocognitive level at different times (before and after radiotherapy treatment). * patient cognitive tests (½ day face-to-face consultation/assessment with a neuropsychologist specialising in paediatrics, followed by a 30-minute telephone call). Only for patients having received their radiotherapy treatment at the IUCT-O: a multimodal MRI specific to the study (without injection of contrast product) may be performed at inclusion and 2 years after inclusion.
Locations (15)
CHU Angers
Angers, France
CHU de Bordeaux
Bordeaux, France
Centre François Baclesse
Caen, France
Centre Georges François Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
APHM - Hôpital la Timone
Marseille, France
Institut du Cancer de Montpellier
Montpellier, France
Institut Curie
Paris, France
Centre Eugène Marquis
Rennes, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Centre Paul Strauss
Strasbourg, France
IUCT-O
Toulouse, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
Villejuif, France