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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 14
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Angers
NOT_YET_RECRUITING
Angers
CHU de Bordeaux
RECRUITING
Bordeaux
Centre François Baclesse
NOT_YET_RECRUITING
Caen
Centre Georges François Leclerc
NOT_YET_RECRUITING
Dijon
Centre Oscar Lambret
NOT_YET_RECRUITING
Lille
Centre Léon Bérard
RECRUITING
Lyon
APHM - Hôpital la Timone
NOT_YET_RECRUITING
Marseille
Institut du Cancer de Montpellier
NOT_YET_RECRUITING
Montpellier
Institut Curie
NOT_YET_RECRUITING
Paris
Centre Eugène Marquis
NOT_YET_RECRUITING
Rennes
Institut de Cancérologie de l'Ouest
NOT_YET_RECRUITING
Saint-herblain
Centre Paul Strauss
RECRUITING
Strasbourg
IUCT-O
RECRUITING
Toulouse
Institut de Cancérologie de Lorraine
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Institut Gustave Roussy
RECRUITING
Villejuif
Contact Information
Primary
Anne LAPRIE
laprie.anne@iuct-oncopole.fr
05 31 15 54 43
Time Frame
Start Date: 2025-10-21
Estimated Completion Date: 2030-10
Participants
Target number of participants: 130
Treatments
Other: Patients with a brain tumour treated with radiotherapy in the first line 2 years prior to inclusion.
Related Therapeutic Areas
Sponsors
Leads: Institut Claudius Regaud

This content was sourced from clinicaltrials.gov