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NCT06599879Recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
130 (estimated)
First submitted
5 Sept 2024
Start date
21 Oct 2025
Primary completion date
Oct 2030
Lead sponsor
Institut Claudius Regaud
NCT number
NCT06599879

What you commit to

  • Study type: Interventional
  • Planned participants: 130
  • From 21 Oct 2025 to the primary completion date, Oct 2030
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patient with a recurrence of the disease.
  • 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).
  • Any psychological, family, geographical or sociological condition that prevents compliance with medical monitoring and/or the procedures set out in the study protocol.
  • Severe posterior fossa syndrome with akinetic mutism.

Other

  • Patient presenting with severe ataxia.
  • Not applicable since protocol version 2. Metastatic patient.
  • Patients undergoing psychostimulant or psychotropic treatment (in particular methylphenidate, antidepressants).
  • Patients deprived of their liberty or under legal protection.

Who the study is looking for

  • 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.

Age in the registry: 6 years to 14 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Angers
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AngersFranceRecruiting
CHU de Bordeaux
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BordeauxFranceRecruiting
Centre François Baclesse
Coordinator of this site? Confirm its status
CaenFranceRecruiting
Centre Oscar Lambret
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LilleFranceNot yet recruiting
Centre Leon Berard
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LyonFranceRecruiting
Aphm - Hopital La Timone
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MarseilleFranceRecruiting
Institut du Cancer de Montpellier
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MontpellierFranceNot yet recruiting
Institut Curie
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ParisFranceNot yet recruiting
Centre Eugène Marquis
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RennesFranceRecruiting
Institut de Cancérologie de l'Ouest
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Saint-HerblainFranceNot yet recruiting
Centre Paul Strauss
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StrasbourgFranceRecruiting
IUCT-O
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ToulouseFranceRecruiting
Institut de Cancérologie de Lorraine
Coordinator of this site? Confirm its status
Vandœuvre-lès-NancyFranceRecruiting
Institut Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.