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New treatment option for Brain Tumor, Pediatric
Official title Irradiation in Paediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention
ClinicalTrials.gov ID: NCT06599879
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 14
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- 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.
- 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.
- 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 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.
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Bordeaux, France
- Caen, France
- Dijon, France
- Lille, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Paris, France
- Rennes, France
- Saint-Herblain, France
- Strasbourg, France
- Toulouse, France
- Vandœuvre-lès-Nancy, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 14 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Bordeaux, France; Caen, France; Dijon, France; Lille, France; Lyon, France and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.