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

Last updated: February 6, 2026
Sponsor: Institut Claudius Regaud
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Neuropsychological assessments:

Clinical Study ID

NCT06599879
24TETE01
  • Ages 6-14
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Patient who has received localised brain irradiation or craniospinal irradiation fora brain tumour whose treatment includes first-line radiotherapy.

  2. Patient with one of the following tumour types: ependymomas, medulloblastomas,malignant germ cell tumours, craniopharyngioma, pinealoblastoma.

  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 writtenexpression capacity to carry out the neuropsychological tests properly.

  7. Proficiency in the French language by the patient and parent(s).

  8. Patient affiliated to a Social Security scheme in France.

  9. Informed consent signed by the patient/legal parent(s)/guardian(s) in accordancewith French law and Good Clinical Practice.

Exclusion

Exclusion Criteria:

  1. Patient presenting with severe ataxia.

  2. Patient with a recurrence of the disease.

  3. Not applicable since protocol version 2. Metastatic patient.

  4. Any contraindication to MRI for patients included in Toulouse (i.e. in particularpatients with a pacemaker or cardiac defibrillator, implanted equipment activated byan electrical, magnetic or mechanical system, patients with haemostatic clips onintracerebral aneurysms, patients with orthopaedic implants, claustrophobicpatients).

  5. Patients undergoing psychostimulant or psychotropic treatment (in particularmethylphenidate, antidepressants).

  6. Any psychological, family, geographical or sociological condition that preventscompliance with medical monitoring and/or the procedures set out in the studyprotocol.

  7. Patients deprived of their liberty or under legal protection.

  8. Severe posterior fossa syndrome with akinetic mutism.

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: Neuropsychological assessments:
Phase:
Study Start date:
October 21, 2025
Estimated Completion Date:
October 31, 2030

Connect with a study center

  • CHU Angers

    Angers,
    France

    Site Not Available

  • CHU Angers

    Angers 3037656,
    France

    Site Not Available

  • CHU de Bordeaux

    Bordeaux,
    France

    Site Not Available

  • CHU de Bordeaux

    Bordeaux 3031582,
    France

    Active - Recruiting

  • Centre François Baclesse

    Caen,
    France

    Site Not Available

  • Centre François Baclesse

    Caen 3029241,
    France

    Site Not Available

  • Centre Georges François Leclerc

    Dijon,
    France

    Site Not Available

  • Centre Georges François Leclerc

    Dijon 3021372,
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille,
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille 2998324,
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon,
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon 2996944,
    France

    Active - Recruiting

  • APHM - Hôpital la Timone

    Marseille,
    France

    Site Not Available

  • APHM - Hôpital la Timone

    Marseille 2995469,
    France

    Site Not Available

  • Institut du Cancer de Montpellier

    Montpellier,
    France

    Site Not Available

  • Institut du Cancer de Montpellier

    Montpellier 2992166,
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice,
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice 2990440,
    France

    Site Not Available

  • Institut Curie

    Paris,
    France

    Site Not Available

  • Institut Curie

    Paris 2988507,
    France

    Site Not Available

  • Centre Eugène Marquis

    Rennes,
    France

    Site Not Available

  • Centre Eugène Marquis

    Rennes 2983990,
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain 2979590,
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest

    Saint-herblain,
    France

    Site Not Available

  • ICANS

    Strasbourg,
    France

    Site Not Available

  • Centre Paul Strauss

    Strasbourg 2973783,
    France

    Active - Recruiting

  • ICANS

    Strasbourg 2973783,
    France

    Site Not Available

  • IUCT-O

    Toulouse,
    France

    Site Not Available

  • IUCT-O

    Toulouse 2972315,
    France

    Active - Recruiting

  • Institut de Cancérologie de Lorraine

    Vandoeuvre-les-nancy,
    France

    Site Not Available

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy 2970797,
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif,
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif 2968705,
    France

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.