ToNIC / UMR1214
Toulouse, 31024, France
NCT Number: NCT04324450
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.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Toulouse, 31024, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
FOR ALL PARTICIPANTS
FOR IRRADIATED PATIENTS
FOR PATIENTS TREATED BY SURGERY AND/OR CHEMOTHERAPY
Exclusion criteria
FOR ALL PARTICIPANTS
FOR HEALTHY VOLUNTEERS
The MRI protocol is composed of:
Battery of neuropsychological tests
Time frame: Day 1
Volume of the hippocampus obtained from T1-weighted anatomical
Time frame: Day 1
Cortical thickness of the hippocampus obtained from T1-weighted anatomical
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
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)
Time frame: Day 2
Scores obtained at memory clinical scale for children
Time frame: Day 2
Scores obtained at Wechsler Intelligence Scale for Children
Time frame: Day 2
Scores obtained at Serial Reaction Time Task
Time frame: Day 2
Scores obtained at Wechsler Intelligence Scale for Children
Time frame: Day 2
Scores obtained at Wechsler Memory Scale
Time frame: Day 2
Scores obtained at Wechsler Intelligence Scale for Children
Time frame: Day 2
Scores obtained at Peabody Picture Vocabulary Test
Time frame: Day 2
Scores obtained at Purdue Pegboard Test
Time frame: Day 2
Scores obtained at TMT A and B, Stroop Test and Wisconsin Card Sorting Test
Time frame: Day 2
Scores obtained at Test of Attentional Performance 2.3.1
Time frame: Day 1
Cerebellar volume obtained from T1-weighted anatomical sequences
Time frame: Day 1
Micro-structural integrity of the cerebellum achieved by using DTI sequences to calculate the fraction of anisotropy and average diffusivity
Time frame: Day 1
Cerebral blood volume obtained from brain perfusion imaging
Time frame: Day 1
Post-therapeutic hypoxia as measured by magnetic resonance spectrometry of the hippocampus and cerebellum
Time frame: Day 1
Neuronal density as measured by magnetic resonance spectrometry of the hippocampus and cerebellum
Time frame: Day 1
Functional connectivity index, obtained via resting functional MRI.
Time frame: Day 1
Age at the time of treatment from the patients' medical records
Time frame: Day 1
Radiotherapy doses received in the cerebellum, in the hippocampus, and in the whole brain from the patients' medical records
Time frame: Day 1
Cerebellum and hippocampus Normal Tissue Complication Probability (NTCP)
Institut National de la Santé Et de la Recherche Médicale, France
Other Gov
Acronym: IMPALA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02045381
Adenocarcinoma, Brain Diseases
Ann Arbor, Michigan, United States
View Trial DetailsNCT06583395
Adnexal Diseases, Amyotrophic Lateral Sclerosis
Palm Desert, California, United States
View Trial DetailsNCT03561896
Brain Diseases, Brain Metastases, Adult
Bellinzona, Canton Ticino, Switzerland
View Trial DetailsNCT04646213
Brain Diseases, Brain Neoplasms
Richmond, Virginia, United States
View Trial Details