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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Years - 14 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patient who has received localised brain irradiation or craniospinal irradiation for a brain tumour whose treatment includes first-line radiotherapy. 2. Patient with localised disease and one of the following tumour types: ependymomas, medulloblastomas, malignant germ cell tumours, craniopharyngioma. 3. Patient aged between 4 and 12 years at the time of radiotherapy treatment. 4. End of irradiation within 2 years (+/-3 months) prior to inclusion. 5. Patient having been treated by photontherapy or proton therapy. 6. Sufficient visual, auditory (with authorised hearing aid) and oral or written expression capacity to carry out the neuropsychological tests properly. 7. The patient's mother tongue is French. 8. Patient affiliated to a Social Security scheme in France. 9. Informed consent signed by the patient/legal parent(s)/guardian(s) in accordance with French law and Good Clinical Practice.

Exclusion Criteria:

1. Patient presenting with severe ataxia. 2. Patient with a recurrence of the disease. 3. Metastatic patient. 4. 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). 5. Patients undergoing psychostimulant or psychotropic treatment (in particular methylphenidate, antidepressants). 6. Any psychological, family, geographical or sociological condition that prevents compliance with medical monitoring and/or the procedures set out in the study protocol. 7. Patients deprived of their liberty or under legal protection.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06599879
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Institut Claudius Regaud
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumor, Pediatric

Arms & Interventions

Arms

Other: Patients with a brain tumour treated with radiotherapy in the first line 2 years prior to inclusion.

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.

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International Sites

CHU Angers, Angers, France

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Emilie DE CARLI

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