Hippocampal radiation dose and memory in children treated for brain tumors
Irradiation in Paediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention
This project will test whether the amount of radiation the hippocampus receives is linked to later memory problems in children treated with brain irradiation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 6 Years to 14 Years |
| Sex | All |
| Sponsor | Institut Claudius Regaud Academic / other |
| Locations | 15 sites (Angers and 14 other locations) |
| Trial ID | NCT06599879 on ClinicalTrials.gov |
What this trial studies
This is a prospective, open-label, multicenter study enrolling children who received localized or craniospinal radiotherapy for selected brain tumors between ages 4 and 12. Neuropsychological testing, parental questionnaires, and neuroimaging will measure declarative memory, attention, and brain changes at about 2 years and 4 years after radiotherapy, with a retrospective parental report of baseline function one year before diagnosis. Radiation dose to the hippocampus will be reconstructed from photon or proton treatment plans and correlated with memory outcomes to define dose–response relationships. The study is carried out at several French oncology centers and requires French language proficiency and social security coverage.
Who should consider this trial
Good fit: Children who were 4–12 years old at the time of photon or proton radiotherapy for specified tumors (ependymoma, medulloblastoma, malignant germ cell tumor, craniopharyngioma, pinealoblastoma), who finished irradiation about two years ago, can complete neuropsychological testing, speak French, and have French social security are ideal candidates.
Not a fit: Patients with severe neurological or communication impairments that prevent proper neuropsychological testing, non‑French speakers, those treated outside the specified age or timing windows, or without French social security are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the results could guide radiotherapy planning to better spare the hippocampus and reduce long-term memory problems in pediatric brain tumor survivors.
How similar studies have performed: Adult research has linked hippocampal dose to memory decline and shown promise for hippocampal‑sparing techniques, while pediatric evidence is more limited and suggestive but not yet definitive.
Eligibility criteria
Show full 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 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 written expression 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 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. Not applicable since protocol version 2. 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. 8. Severe posterior fossa syndrome with akinetic mutism.
Where this trial is running
Angers and 14 other locations
- CHU Angers — Angers, France (Recruiting)
- CHU de Bordeaux — Bordeaux, France (Recruiting)
- Centre François Baclesse — Caen, France (Recruiting)
- Centre Georges François Leclerc — Dijon, France (Not_yet_recruiting)
- Centre Oscar Lambret — Lille, France (Not_yet_recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
- APHM - Hôpital la Timone — Marseille, France (Not_yet_recruiting)
- Institut du Cancer de Montpellier — Montpellier, France (Not_yet_recruiting)
- Institut Curie — Paris, France (Not_yet_recruiting)
- Centre Eugène Marquis — Rennes, France (Not_yet_recruiting)
- Institut de Cancérologie de l'Ouest — Saint-Herblain, France (Not_yet_recruiting)
- Centre Paul Strauss — Strasbourg, France (Recruiting)
- Iuct-O — Toulouse, France (Recruiting)
- Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, France (Recruiting)
- Institut Gustave Roussy — Villejuif, France (Recruiting)
Study contacts
- Study coordinator: Anne LAPRIE
- Email: laprie.anne@iuct-oncopole.fr
- Phone: 05 31 15 54 43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.