Trial Title:
Irradiation in Paediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention
NCT ID:
NCT06599879
Condition:
Brain Tumor, Pediatric
Conditions: Official terms:
Brain Neoplasms
Conditions: Keywords:
Brain Tumor, Pediatric
Radiotherapy
Neurocognitive sequelae
Imaging
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Neuropsychological assessments:
Description:
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.
Arm group label:
Patients with a brain tumour treated with radiotherapy in the first line 2 years prior to inclusion.
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.
Criteria for 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.
Gender:
All
Minimum age:
6 Years
Maximum age:
14 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Angers
Address:
City:
Angers
Country:
France
Contact:
Last name:
Emilie DE CARLI
Phone:
02 41 35 38 63
Email:
emdecarli@chu-angers.fr
Facility:
Name:
CHU de Bordeaux
Address:
City:
Bordeaux
Country:
France
Contact:
Last name:
Aymeri HUCHET
Phone:
05 57 62 33 00
Email:
aymeri.huchet@chu-bordeaux.fr
Facility:
Name:
Centre François Baclesse
Address:
City:
Caen
Country:
France
Contact:
Last name:
Jordan BOUTER
Phone:
02 31 45 50 50
Email:
j.bouter@baclesse.unicancer.fr
Facility:
Name:
Centre Georges François Leclerc
Address:
City:
Dijon
Country:
France
Contact:
Last name:
Gilles TRUC
Phone:
03 80 73 75 18
Email:
gtruc@cgfl.fr
Facility:
Name:
Centre Oscar Lambret
Address:
City:
Lille
Country:
France
Contact:
Last name:
Xavier MIRABEL
Phone:
03 20 29 59 11
Email:
x-mirabel@o-lambret.fr
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Country:
France
Contact:
Last name:
Cécile FAURE-CONTER
Phone:
04 78 78 59 58
Email:
cecile.conter@ihope.fr
Facility:
Name:
APHM - Hôpital la Timone
Address:
City:
Marseille
Country:
France
Contact:
Last name:
Xavier MURRACIOLE
Phone:
04 91 38 43 34
Email:
xavier.muracciole@ap-hm.fr
Facility:
Name:
Institut du Cancer de Montpellier
Address:
City:
Montpellier
Country:
France
Contact:
Last name:
Marie CANTALOUBE
Phone:
04 67 61 45 25
Email:
marie.cantaloube@icm.unicancer.fr
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Country:
France
Contact:
Last name:
Pierre-Yves BONDIAU
Phone:
04 92 03 10 70
Email:
pierre-yves.bondiau@nice.unicancer.fr
Facility:
Name:
Institut Curie
Address:
City:
Paris
Country:
France
Contact:
Last name:
Emmanuel JOUGLAR
Phone:
01 44 32 46 25
Email:
emmanuel.jouglar@curie.fr
Facility:
Name:
Centre Eugène Marquis
Address:
City:
Rennes
Country:
France
Contact:
Last name:
Loïg DUVERGE
Phone:
02 99 25 30 92
Email:
l.duverge@rennes.unicancer.fr
Facility:
Name:
Institut de Cancérologie de l'Ouest
Address:
City:
Saint-herblain
Country:
France
Contact:
Last name:
Luc OLLIVIER
Phone:
02 40 67 99 00
Email:
luc.ollivier@ico.unicancer.fr
Facility:
Name:
ICANS
Address:
City:
Strasbourg
Country:
France
Contact:
Last name:
Georges NOEL
Phone:
03 68 76 69 69
Email:
g.noel@icans.eu
Facility:
Name:
IUCT-O
Address:
City:
Toulouse
Country:
France
Contact:
Last name:
Anne LAPRIE
Phone:
05 31 15 54 43
Email:
laprie.anne@iuct-oncopole.fr
Facility:
Name:
Institut de Cancérologie de Lorraine
Address:
City:
Vandoeuvre-les-nancy
Country:
France
Contact:
Last name:
Maria JOLNEROVSKI
Phone:
03 83 59 84 27
Email:
m.jolnerovski@nancy.unicancer.fr
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Country:
France
Contact:
Last name:
Noura SELLAMI
Phone:
01 42 11 55 42
Email:
noura.sellami@gustave.fr
Start date:
October 2024
Completion date:
October 2029
Lead sponsor:
Agency:
Institut Claudius Regaud
Agency class:
Other
Source:
Institut Claudius Regaud
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06599879
