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RECRUITING
NCT06599879
NA

Irradiation in Paediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention

Sponsor: Institut Claudius Regaud

View on ClinicalTrials.gov

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

Interventions

OTHER

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