Memory Neuroimaging in Children, Adolescents and Young Adults Following Pediatric Cancer

NCT ID: NCT04324450

Last Updated: 2025-09-04

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-12

Study Completion Date

2021-08-19

Brief Summary

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Brain tumours are the leading cause of cancer-related death and morbidity in children, adolescents and young adults. The brain is also one of the most sensitive organs to treatments used in pediatric oncology, even for cancers not related to the central nervous system. Therapeutic index is therefore a major issue in pediatric neuro-oncology. The efficacy of the therapy as well as its toxicity are difficult to measure using standard tests. In order to optimize therapies that could have an impact on the brain, and consequently on the quality of life of patients, it becomes crucial to optimize the means of evaluation.

Few studies to date have focused on the various components of memory impacted following treatment of a posterior fossa tumour. However, supra-tentorial structures such as the hippocampus, which have long been described for their role in memory, are either partially irradiated (irradiated in their lower part due to their proximity to the target volume during irradiation of the posterior fossa) or completely irradiated (e.g. included in the prophylactic irradiation of medulloblastoma prior to dose supplementation in the posterior fossa). On the other hand, the cerebellum plays a central role in learning and procedural memory involved in motor and cognitive learning, as it enables automation and procedural retention such as reading (automation of the grapho-phonemic conversion procedure) or arithmetic (mental arithmetic).

IMPALA study is aimed at investigating the impact of different irradiation doses received by children treated with radiotherapy on cognitive functions related to the hippocampus and to the cerebellum.

This exploratory study will thus provide elements enabling a better limitation of radiotherapy doses on regions linked to the development of cognition and memory. The project brings together researchers and clinicians with complementary expertise in oncology, neurology and imaging in both children and adults. This study will also provide a better understanding of the role of the cerebellum in memory and executive functions, and develop a method that can then be used in a prospective longitudinal multicentre form.

Detailed Description

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Conditions

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Cancer Brain Pediatric Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients radiotherapy +

Patients cured of a brain tumour and who have received radiotherapy in childhood

Group Type EXPERIMENTAL

MRI

Intervention Type DEVICE

The MRI protocol is composed of:

* T1-weighted anatomical sequences
* DTI sequences
* resting functional MRI
* 3D MR spectroscopic imaging

Cognitive assessment

Intervention Type BEHAVIORAL

Battery of neuropsychological tests

Patients radiotherapy -

Patients cured of a brain tumour and who have received surgery and/or chemotherapy but were not irradiated

Group Type EXPERIMENTAL

MRI

Intervention Type DEVICE

The MRI protocol is composed of:

* T1-weighted anatomical sequences
* DTI sequences
* resting functional MRI
* 3D MR spectroscopic imaging

Cognitive assessment

Intervention Type BEHAVIORAL

Battery of neuropsychological tests

Healthy volunteers

Healthy volunteers (control group) matched in age, manual laterality, gender and parental education to "Patients radiotherapy +"

Group Type EXPERIMENTAL

MRI

Intervention Type DEVICE

The MRI protocol is composed of:

* T1-weighted anatomical sequences
* DTI sequences
* resting functional MRI
* 3D MR spectroscopic imaging

Cognitive assessment

Intervention Type BEHAVIORAL

Battery of neuropsychological tests

Interventions

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MRI

The MRI protocol is composed of:

* T1-weighted anatomical sequences
* DTI sequences
* resting functional MRI
* 3D MR spectroscopic imaging

Intervention Type DEVICE

Cognitive assessment

Battery of neuropsychological tests

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

FOR ALL PARTICIPANTS

* Affiliation to or beneficiary of a social security scheme
* French mother tongue
* Sufficient visual, auditory (hearing aids permitted), speaking and writing skills for proper performance of neuropsychological tests
* Written informed consent of the adult participant, or of the representatives of parental authority, if applicable

FOR IRRADIATED PATIENTS

* Patient treated before 18 years old
* Patient considered cured after irradiation of a brain tumour (complete clinical and iconographic response at 5 years after the end of radiotherapy).
* Patient who has received localized brain irradiation or craniospinal irradiation for a brain tumour whose treatment includes first-line radiotherapy (ependymomas, medulloblastomas, malignant germinal tumours)
* Patient who received 54 or 59.4 Gy in a localized part of the posterior fossa or supra-tentorial brain; or patients who received 54 Gy over all or part of the posterior fossa and prophylactic irradiation of the entire brain

FOR PATIENTS TREATED BY SURGERY AND/OR CHEMOTHERAPY

* Patients resected from a posterior fossa tumour without radiotherapy (i.e., brain tumours whose treatment does not include first-line radiotherapy: low-grade gliomas including pilocytic astrocytomas)
* Patient treated before 18 years old
* Patient considered cured at 5 years after the end of treatment

Exclusion Criteria

FOR ALL PARTICIPANTS

* Individual under legal protection of adults (judicial safeguard, guardianship, curatorship, institutionalized, or under a mandate for future protection)
* Severe ataxia
* Individual who participated in another research study that included treatment within the previous 3 years
* Individual with a contraindication to MRI (i.e. in particular, cardiac pacemaker or defibrillator carriers, implanted equipment activated by an electrical, magnetic or mechanical system, carriers of haemostatic clips on intracerebral aneurysms, carriers of orthopaedic implants, claustrophobic)

FOR HEALTHY VOLUNTEERS

* Known neurological or psychiatric history
* History of learning disability or neurodevelopmental disorder follow-up
* Patients undergoing psychotropic treatment (methylphenidate, antidepressants, etc.).
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne LAPRIE

Role: PRINCIPAL_INVESTIGATOR

ToNIC / UMR1214

Locations

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ToNIC / UMR1214

Toulouse, , France

Site Status

Countries

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France

References

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Baudou E, Pariente J, Peran P, Tensaouti F, Pollidoro L, Meligne D, Ducassou A, Gros-Dagnac H, Arribarat G, Desirat JP, Bertozzi AI, Gambart M, Larrieu-Ciron D, Barbolosi D, Muracciole X, Lemesle B, Sevely A, Roques M, Cazaux M, Tallet J, Danna J, Chaix Y, Laprie A. A prospective behavioral and imaging study exploring the impact on long-term memory of radiotherapy delivered for a brain tumor in childhood and adolescence. Clin Transl Radiat Oncol. 2021 Nov 7;33:7-14. doi: 10.1016/j.ctro.2021.10.006. eCollection 2022 Mar.

Reference Type BACKGROUND
PMID: 34988299 (View on PubMed)

Baudou E, Danna J, Tallet J, Pollidoro L, Tensaouti F, Bertozzi AI, Pariente J, Courbieres N, Dufour C, Grill J, Chaix Y, Laprie A. Impact of a pediatric posterior fossa tumor and its treatments on motor procedural learning. Eur J Paediatr Neurol. 2023 May;44:37-45. doi: 10.1016/j.ejpn.2023.03.005. Epub 2023 Apr 10.

Reference Type BACKGROUND
PMID: 37060708 (View on PubMed)

Baudou E, Peran P, Tensaouti F, Arribarat G, Pariente J, Courbieres N, Pollidoro L, Bertozzi AI, Gambart M, Sevely A, Roques M, Ducassou A, Danna J, Tallet J, Dufour C, Chaix Y, Laprie A. The long-term impact of irradiation on functional connectivity in brain circuits involved in memory processes after pediatric posterior fossa tumor. Radiother Oncol. 2024 Feb;191:110073. doi: 10.1016/j.radonc.2023.110073. Epub 2023 Dec 23.

Reference Type BACKGROUND
PMID: 38145791 (View on PubMed)

Habibi AT, Alaya IB, Tensaouti F, Baudou E, Arribarat G, Pollidoro L, Peran P, Chaix Y, Labidi S, Laprie A. Impact of Pediatric Posterior Fossa Tumor Treatments on Working Memory Tracts Using Resting-State fMRI and Tractography. J Neuroimaging. 2025 Jan-Feb;35(1):e70007. doi: 10.1111/jon.70007.

Reference Type BACKGROUND
PMID: 39789950 (View on PubMed)

Other Identifiers

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C19-17

Identifier Type: -

Identifier Source: org_study_id

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