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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-21

Study Completion Date

2030-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory

NCT02750371

Cavernous Sinus Meningioma Pituitary Adenoma

COMPLETED NA

MR Imaging Study of TBI in Children

NCT03034031

TBI (Traumatic Brain Injury)

RECRUITING

Long Term Neurocognitive Effects of Low-dose Radiation in the Brain: Study of 150 Patients in the French Hemangioma Cohort

NCT01960751

Patients Treated by Radiotherapy with < One Gy to the Brain

COMPLETED NA

Hippocampal Radiation Exposure and Memory

NCT00603694

Arteriovenous Malformation Schwannoma Trigeminal Neuralgia

COMPLETED

Multicenter Study on Rehabilitation Medical Data for Pediatric Big Brain Development

NCT06367920

Pediatric ALL Healthy

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Tumor, Pediatric

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with a brain tumour treated with radiotherapy in the first line 2 years prior to inclusion.

Group Type OTHER

Neuropsychological assessments:

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neuropsychological assessments:

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No