Cancer BrainIMPALANCT04324450
Memory Neuroimaging in Children, Adolescents and Young Adults Following Pediatric Cancer
A study testing MRI and Cognitive assessment in people with Cancer Brain and Pediatric Cancer, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cancer Brain, Pediatric Cancer
- What is being tested?
- MRI and Cognitive assessment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2020to 19 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- Known neurological or psychiatric history
- History of learning disability or neurodevelopmental disorder follow-up
- Patients undergoing psychotropic treatment (methylphenidate, antidepressants, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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
- Being tested
- MRI, Cognitive assessment
- Keywords
- brain tumour, child, memory, radiotherapy, MRI
- Medical subject headings
- Brain Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
The MRI protocol is composed of:
- T1-weighted anatomical sequences
- DTI sequences
- resting functional MRI
- 3D MR spectroscopic imaging
Cognitive assessmentBehavioural
Battery of neuropsychological tests
| Study group | Role | What they receive |
|---|---|---|
| Patients radiotherapy + | Experimental | Patients cured of a brain tumour and who have received radiotherapy in childhood Receives: 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 Receives: Device: MRI; Behavioral: Cognitive assessment |
| Healthy volunteers | Experimental | Healthy volunteers (control group) matched in age, manual laterality, gender and parental education to "Patients radiotherapy +" Receives: Device: MRI; Behavioral: Cognitive assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural characteristics of declarative memory neuronal substrate: volume of the hippocampus
Volume of the hippocampus obtained from T1-weighted anatomical
Measured: Day 1
Structural characteristics of declarative memory neuronal substrate: cortical thickness of the hippocampus
Cortical thickness of the hippocampus obtained from T1-weighted anatomical
Measured: 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
Measured: 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)
Measured: Day 2
Secondary outcomes (19)
Declarative episodic memory assessment scores
Scores obtained at memory clinical scale for children
Measured: Day 2
Declarative semantic memory assessment scores
Scores obtained at Wechsler Intelligence Scale for Children
Measured: Day 2
Procedural memory assessment scores
Scores obtained at Serial Reaction Time Task
Measured: Day 2
Short-term auditive memory assessment scores
Scores obtained at Wechsler Intelligence Scale for Children
Measured: Day 2
Short-term visual memory assessment scores
Scores obtained at Wechsler Memory Scale
Measured: Day 2
Intellectual capacities assessment scores
Scores obtained at Wechsler Intelligence Scale for Children
Measured: Day 2
Language assessment scores
Scores obtained at Peabody Picture Vocabulary Test
Measured: Day 2
Motor functions assessment scores
Scores obtained at Purdue Pegboard Test
Measured: Day 2
Executive functions assessment scores
Scores obtained at TMT A and B, Stroop Test and Wisconsin Card Sorting Test
Measured: Day 2
Attentional capacities assessment scores
Scores obtained at Test of Attentional Performance 2.3.1
Measured: Day 2
Cerebellar volume
Cerebellar volume obtained from T1-weighted anatomical sequences
Measured: Day 1
Micro-structural integrity of the cerebellum
Micro-structural integrity of the cerebellum achieved by using DTI sequences to calculate the fraction of anisotropy and average diffusivity
Measured: Day 1
Cerebral blood volume obtained from brain perfusion imaging
Cerebral blood volume obtained from brain perfusion imaging
Measured: Day 1
Post-therapeutic hypoxia
Post-therapeutic hypoxia as measured by magnetic resonance spectrometry of the hippocampus and cerebellum
Measured: Day 1
Neuronal density
Neuronal density as measured by magnetic resonance spectrometry of the hippocampus and cerebellum
Measured: Day 1
Functional connectivity index
Functional connectivity index, obtained via resting functional MRI.
Measured: Day 1
Age at the time of treatment
Age at the time of treatment from the patients' medical records
Measured: Day 1
Radiotherapy doses
Radiotherapy doses received in the cerebellum, in the hippocampus, and in the whole brain from the patients' medical records
Measured: Day 1
Cerebellum and hippocampus Normal Tissue Complication Probability
Cerebellum and hippocampus Normal Tissue Complication Probability (NTCP)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start12 Feb 2020
- Primary completion19 Aug 2021
- Study completion19 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cancer BrainStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anne LAPRIE, Principal investigator, ToNIC / UMR1214
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324450
- Sponsor's protocol ID
- C19-17
- Acronym
- IMPALA
- Status last verified
- Mar 2025
- First submitted
- 7 Feb 2020
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34988299Baudou 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.
PubMed 37060708Baudou 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.
PubMed 38145791Habibi 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.
PubMed 39789950
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory Neuroimaging in Children, Adolescents and Young Adults Following Pediatric Cancer
- ClinicalTrials.gov ID
- NCT04324450
- Acronym / sponsor ID
- IMPALA / C19-17
- Conditions
- Cancer Brain, Pediatric Cancer
- Keywords
- brain tumour, child, memory, radiotherapy, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients radiotherapy + | Experimental | Device: MRI, Behavioral: Cognitive assessmentPatients cured of a brain tumour and who have received radiotherapy in childhood |
| Patients radiotherapy - | Experimental | Device: MRI, Behavioral: Cognitive assessmentPatients cured of a brain tumour and who have received surgery and/or chemotherapy but were not irradiated |
| Healthy volunteers | Experimental | Device: MRI, Behavioral: Cognitive assessmentHealthy volunteers (control group) matched in age, manual laterality, gender and parental education to "Patients radiotherapy +" |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIThe MRI protocol is composed of: * T1-weighted anatomical sequences * DTI sequences * resting functional MRI * 3D MR spectroscopic imaging | Device | Healthy volunteers, Patients radiotherapy +, Patients radiotherapy - |
| Cognitive assessmentBattery of neuropsychological tests | Behavioural | Healthy volunteers, Patients radiotherapy +, Patients radiotherapy - |
Primary outcome
Structural characteristics of declarative memory neuronal substrate: volume of the hippocampus
Time frame: Day 1
Volume of the hippocampus obtained from T1-weighted anatomical
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
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
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)
19 secondary outcomes
Declarative episodic memory assessment scores
Time frame: Day 2
Declarative semantic memory assessment scores
Time frame: Day 2
Procedural memory assessment scores
Time frame: Day 2
Short-term auditive memory assessment scores
Time frame: Day 2
Short-term visual memory assessment scores
Time frame: Day 2
Intellectual capacities assessment scores
Time frame: Day 2
Language assessment scores
Time frame: Day 2
Motor functions assessment scores
Time frame: Day 2
Executive functions assessment scores
Time frame: Day 2
Attentional capacities assessment scores
Time frame: Day 2
Cerebellar volume
Time frame: Day 1
Micro-structural integrity of the cerebellum
Time frame: Day 1
Cerebral blood volume obtained from brain perfusion imaging
Time frame: Day 1
Post-therapeutic hypoxia
Time frame: Day 1
Neuronal density
Time frame: Day 1
Functional connectivity index
Time frame: Day 1
Age at the time of treatment
Time frame: Day 1
Radiotherapy doses
Time frame: Day 1
Cerebellum and hippocampus Normal Tissue Complication Probability
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 34988299Baudou 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.
- Results publication: PubMed 37060708Baudou 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.
- Results publication: PubMed 38145791Baudou 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.
- Results publication: PubMed 39789950Habibi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne LAPRIE principal investigator
ToNIC / UMR1214
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and Cognitive assessment in people with Cancer Brain and Pediatric Cancer, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural characteristics of declarative memory neuronal substrate: volume of the hippocampus (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324450, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.