Brain Tumor, PediatricIPANEMANCT06599879
Irradiation in Paediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention
A study testing Neuropsychological assessments: in people with Brain Tumor, Pediatric, run by Institut Claudius Regaud at 14 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Brain Tumor, Pediatric
- What is being tested?
- Neuropsychological assessments:
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 14 sitesFrance
- Study dates
- 21 Oct 2025to Oct 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- Patient presenting with severe ataxia.
- Patient with a recurrence of the disease.
- Not applicable since protocol version 2. Metastatic patient.
- 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).
- Patients undergoing psychostimulant or psychotropic treatment (in particular methylphenidate, antidepressants).
- Any psychological, family, geographical or sociological condition that prevents compliance with medical monitoring and/or the procedures set out in the study protocol.
- Patients deprived of their liberty or under legal protection.
- Severe posterior fossa syndrome with akinetic mutism.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
France14 sites, 14 recruiting
- Recruiting
CHU Angers
Angers
Claire BRISSET, 02 41 35 65 24, Claire.brisset@chu-angers.fr
- Recruiting
CHU de Bordeaux
Bordeaux
Aymeri HUCHET, 05 57 62 33 00, aymeri.huchet@chu-bordeaux.fr
- Recruiting
Centre François Baclesse
Caen
Jordan BOUTER, 02 31 45 50 50, j.bouter@baclesse.unicancer.fr
- Not yet recruiting
Centre Oscar Lambret
Lille
Xavier MIRABEL, 03 20 29 59 11, x-mirabel@o-lambret.fr
- Recruiting
Centre Léon Bérard
Lyon
Cécile FAURE-CONTER, 04 78 78 59 58, cecile.conter@ihope.fr
- Not yet recruiting
APHM - Hôpital la Timone
Marseille
Xavier MURRACIOLE, 04 91 38 43 34, xavier.muracciole@ap-hm.fr
- Not yet recruiting
Institut du Cancer de Montpellier
Montpellier
Marie CANTALOUBE, 04 67 61 45 25, marie.cantaloube@icm.unicancer.fr
- Not yet recruiting
Institut Curie
Paris
Emmanuel JOUGLAR, 01 44 32 46 25, emmanuel.jouglar@curie.fr
- Recruiting
Centre Eugène Marquis
Rennes
Loïg DUVERGE, 02 99 25 30 92, l.duverge@rennes.unicancer.fr
- Not yet recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain
Gaëlle LE QUELLENEC, 02 40 67 99 00, gaelle.lequellenec@ico.unicancer.fr
- Recruiting
Centre Paul Strauss
Strasbourg
Georges NOEL, 03 68 76 69 69, g.noel@icans.eu
- Recruiting
IUCT-O
Toulouse
Anne LAPRIE, 05 31 15 54 43, laprie.anne@iuct-oncopole.fr
- Recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy
Maria JOLNEROVSKI, 03 83 59 84 27, m.jolnerovski@nancy.unicancer.fr
- Recruiting
Institut Gustave Roussy
Villejuif
Noura SELLAMI, 01 42 11 55 42, noura.sellami@gustave.fr
About this study
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:
Read more
- 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.
- Conditions
- Brain Tumor, Pediatric
- Being tested
- Neuropsychological assessments:
- Keywords
- Brain Tumor, Pediatric, Radiotherapy, Neurocognitive sequelae, Imaging
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessments:Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a brain tumour treated with radiotherapy in the first line 2 years prior to inclusion. | Other | Not described Receives: Other: Neuropsychological assessments: |
What is being measured
The primary outcome is the main question the study is designed to answer.
A deficit of the declarative memory will be defined by a standard score of the Children' Memory Scale (CMS) ≤ 5
Measured: 24 months for each patient
Secondary outcomes (5)
Declarative memory will be assessed using the adapted EPIREAL test.
Measured: 24 months for each patient
Declarative memory will be assessed by the autobiographical memory question.
Measured: 24 months for each patient
The deficit of the procedural memory will be defined by a score of less than or equal to 10/20 on the last 20 trials (out of 50) of the probabilistic classification task.
Measured: 24 months for each patient
The deficit of the procedural memory will be defined by a specific learning score less than or equal to zero of the adapted serial reaction time task (SRTT).
Measured: 24 months for each patient
Working memory deficit will be defined if at least one of the two subtests (Number memory (WISC-V) and Spatial memory (WNV)) shows a deficit.
For each subtest, a deficit will be defined respectively by a standard score ≤ 5 and a percentile rank ≤ 5.
Measured: 24 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start21 Oct 2025
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor, PediatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599879
- Sponsor's protocol ID
- 24TETE01
- Acronym
- IPANEMA
- Status last verified
- Nov 2025
- First submitted
- 5 Sep 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No