Clinical trial NCT06599879: Irradiation in Paediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention
Official title: Irradiation in Paediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Brain Tumor, Pediatric
Keywords: Brain Tumor, Pediatric
Radiotherapy
Neurocognitive sequelae
Imaging
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 130
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 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.

Primary outcomes:
measure: A deficit of the declarative memory will be defined by a standard score of the Children' Memory Scale (CMS) ≤ 5
timeFrame: 24 months for each patient
Secondary outcomes:
measure: Declarative memory will be assessed using the adapted EPIREAL test.
timeFrame: 24 months for each patient
measure: Declarative memory will be assessed by the autobiographical memory question.
timeFrame: 24 months for each patient
measure: 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.
timeFrame: 24 months for each patient
measure: 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).
timeFrame: 24 months for each patient
measure: 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.
timeFrame: 24 months for each patient
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Caen
country: France
facility: Centre François Baclesse
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: APHM - Hôpital la Timone
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint-herblain
country: France
facility: Institut de Cancérologie de l'Ouest
city: Strasbourg
country: France
facility: ICANS
city: Toulouse
country: France
facility: IUCT-O
city: Vandoeuvre-les-nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: