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

NCT04324450 | Completed

• 1 other identifier: C19-17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Brain; Pediatric Cancer

Keywords

brain tumour; child; memory; radiotherapy; MRI

Outcome Measures

Primary Outcomes (4)

• Structural characteristics of declarative memory neuronal substrate: volume of the hippocampus

  Volume of the hippocampus obtained from T1-weighted anatomical

  Day 1

• Structural characteristics of declarative memory neuronal substrate: cortical thickness of the hippocampus

  Cortical thickness of the hippocampus obtained from T1-weighted anatomical

  Day 1

• Structural characteristics of declarative memory neuronal substrate: Microstructural integrity of the hippocampus

  Microstructural integrity of the hippocampus obtained from Diffusion Tensor Imaging (DTI) sequences used to calculate the fraction of anisotropy and the mean diffusion sequences

  Day 1

• Episodic memory performance

  Episodic memory performance of the participants in the different groups when evaluating episodic declarative memory, assessed with Children's Memory Scale in participants under 16 years old and with Wechsler Memory Scale MEM-III in participants over 16 years old (Day 2)

  Day 2

Secondary Outcomes (19)

• Declarative episodic memory assessment scores

  Day 2

• Declarative semantic memory assessment scores

  Day 2

• Procedural memory assessment scores

  Day 2

• Short-term auditive memory assessment scores

  Day 2

• Short-term visual memory assessment scores

  Day 2

Study Arms (3)

Patients radiotherapy +

EXPERIMENTAL

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

Device: MRI; Behavioral: Cognitive assessment

Patients radiotherapy -

EXPERIMENTAL

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

Device: MRI; Behavioral: Cognitive assessment

Healthy volunteers

EXPERIMENTAL

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

Device: MRI; Behavioral: Cognitive assessment

Interventions

MRI DEVICE

The MRI protocol is composed of: * T1-weighted anatomical sequences * DTI sequences * resting functional MRI * 3D MR spectroscopic imaging

Healthy volunteers; Patients radiotherapy +; Patients radiotherapy -

Cognitive assessment BEHAVIORAL

Battery of neuropsychological tests

Healthy volunteers; Patients radiotherapy +; Patients radiotherapy -

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

ToNIC / UMR1214

Toulouse, 31024, France

Location

Related Publications (4)

• 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.

  PMID: 34988299 BACKGROUND

• 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.

  PMID: 37060708 BACKGROUND

• 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.

  PMID: 38145791 BACKGROUND

• 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.

  PMID: 39789950 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms; Neoplasms

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Anne LAPRIE

  ToNIC / UMR1214

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: March 27, 2020
• Study Start: February 12, 2020
• Primary Completion: August 19, 2021
• Study Completion: August 19, 2021
• Last Updated: September 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)