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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04324450
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.


Condition or disease Intervention/treatment Phase
Cancer Brain Pediatric Cancer Device: MRI Behavioral: Cognitive assessment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Memory Neuroimaging in Children, Adolescents and Young Adults Following Pediatric Cancer
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Patients radiotherapy +
Patients cured of a brain tumour and who have received radiotherapy in childhood
Device: MRI

The MRI protocol is composed of:

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

Behavioral: Cognitive assessment
Battery of neurospychological tests

Experimental: Patients radiotherapy -
Patients cured of a brain tumour and who have received surgery and/or chemotherapy but were not irradiated
Device: MRI

The MRI protocol is composed of:

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

Behavioral: Cognitive assessment
Battery of neurospychological tests

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

The MRI protocol is composed of:

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

Behavioral: Cognitive assessment
Battery of neurospychological tests




Primary Outcome Measures :
  1. Structural characteristics of declarative memory neuronal substrate: volume of the hippocampus [ Time Frame: Day 1 ]
    Volume of the hippocampus obtained from T1-weighted anatomical

  2. Structural characteristics of declarative memory neuronal substrate: cortical thickness of the hippocampus [ Time Frame: Day 1 ]
    Cortical thickness of the hippocampus obtained from T1-weighted anatomical

  3. Structural characteristics of declarative memory neuronal substrate: Microstructural integrity of the hippocampus [ Time Frame: Day 1 ]
    Microstructural integrity of the hippocampus obtained from Diffusion Tensor Imaging (DTI) sequences used to calculate the fraction of anisotropy and the mean diffusion sequences

  4. Episodic memory performance [ Time Frame: Day 2 ]
    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)


Secondary Outcome Measures :
  1. Declarative episodic memory assessment scores [ Time Frame: Day 2 ]
    Scores obtained at memory clinical scale for children

  2. Declarative semantic memory assessment scores [ Time Frame: Day 2 ]
    Scores obtained at Wechsler Intelligence Scale for Children

  3. Procedural memory assessment scores [ Time Frame: Day 2 ]
    Scores obtained at Serial Reaction Time Task

  4. Short-term auditive memory assessment scores [ Time Frame: Day 2 ]
    Scores obtained at Wechsler Intelligence Scale for Children

  5. Short-term visual memory assessment scores [ Time Frame: Day 2 ]
    Scores obtained at Wechsler Memory Scale

  6. Intellectual capacities assessment scores [ Time Frame: Day 2 ]
    Scores obtained at Wechsler Intelligence Scale for Children

  7. Language assessment scores [ Time Frame: Day 2 ]
    Scores obtained at Peabody Picture Vocabulary Test

  8. Motor functions assessment scores [ Time Frame: Day 2 ]
    Scores obtained at Purdue Pegboard Test

  9. Executive functions assessment scores [ Time Frame: Day 2 ]
    Scores obtained at TMT A and B, Stroop Test and Wisconsin Card Sorting Test

  10. Attentional capacities assessment scores [ Time Frame: Day 2 ]
    Scores obtained at Test of Attentional Performance 2.3.1

  11. Cerebellar volume [ Time Frame: Day 1 ]
    Cerebellar volume obtained from T1-weighted anatomical sequences

  12. Micro-structural integrity of the cerebellum [ Time Frame: Day 1 ]
    Micro-structural integrity of the cerebellum achieved by using DTI sequences to calculate the fraction of anisotropy and average diffusivity

  13. Cerebral blood volume obtained from brain perfusion imaging [ Time Frame: Day 1 ]
    Cerebral blood volume obtained from brain perfusion imaging

  14. Post-therapeutic hypoxia [ Time Frame: Day 1 ]
    Post-therapeutic hypoxia as measured by magnetic resonance spectrometry of the hippocampus and cerebellum

  15. Neuronal density [ Time Frame: Day 1 ]
    Neuronal density as measured by magnetic resonance spectrometry of the hippocampus and cerebellum

  16. Functional connectivity index [ Time Frame: Day 1 ]
    Functional connectivity index, obtained via resting functional MRI.

  17. Age at the time of treatment [ Time Frame: Day 1 ]
    Age at the time of treatment from the patients' medical records

  18. Radiotherapy doses [ Time Frame: Day 1 ]
    Radiotherapy doses received in the cerebellum, in the hippocampus, and in the whole brain from the patients' medical records

  19. Cerebellum and hippocampus Normal Tissue Complication Probability [ Time Frame: Day 1 ]
    Cerebellum and hippocampus Normal Tissue Complication Probability (NTCP)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04324450


Contacts
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Contact: Anne LAPRIE, MD +33(0)562746164 laprie.anne@iuct-oncopole.fr

Locations
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France
ToNIC / UMR1214 Recruiting
Toulouse, France, 31024
Contact: Anne LAPRIE, MD    +33(0)562746164    laprie.anne@iuct-oncopole.fr   
Principal Investigator: Anne LAPRIE, MD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Anne LAPRIE ToNIC / UMR1214

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT04324450    
Other Study ID Numbers: C19-17
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
brain tumour
child
memory
radiotherapy
MRI