Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599879
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Irradiation in Paediatrics Neurocognition Neuroimaging and Evaluation of Memory and Attention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Irradiation in Paediatrics Neurocognition Neuroimaging and Evaluation of Memory and Attention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPANEMA
Brief Summary:
This is a prospective open-label multicentric study designed to correlate the dose delivered to the hippocampus with declarative memory deficits 2 years after radiotherapy treatment in a paediatric population who had received brain irradiation between the ages of 4 and 12 for a brain tumour
In order to meet this objective several neuropsychological assessments consisting of parental questionnaires and cognitive tests will be carried out during the course of the study at the following two stages
A 1st assessment at patient inclusion ie 2 years after the end of radiotherapy treatment
And a second assessment 2 years after patient inclusion ie 4 years after the end of radiotherapy treatment
A retrospective assessment of the patients neurocognitive level 1 year before the diagnosis of the disease will also be carried out at inclusion with the parents completing a questionnaire specifically designed for the trial
In addition patients who have received their radiotherapy treatment at the IUCT-O will be offered participation in the ancillary imaging study If the parents and the patient agree multimodal MRI scans specific to the study without injection of contrast will be performed at inclusion and 2 years after inclusion
Imaging and radiotherapy data will be collected in parallel using the PediaRT software used in current practice collection of radiotherapy dosimetric data as well as standard MRI examinations pre-operatively post-operatively and at the 2-year and 4-year follow-up
130 patients will be included in this study
In order to meet this objective several neuropsychological assessments consisting of parental questionnaires and cognitive tests will be carried out during the course of the study at the following two stages
A 1st assessment at patient inclusion ie 2 years after the end of radiotherapy treatment
And a second assessment 2 years after patient inclusion ie 4 years after the end of radiotherapy treatment
A retrospective assessment of the patients neurocognitive level 1 year before the diagnosis of the disease will also be carried out at inclusion with the parents completing a questionnaire specifically designed for the trial
In addition patients who have received their radiotherapy treatment at the IUCT-O will be offered participation in the ancillary imaging study If the parents and the patient agree multimodal MRI scans specific to the study without injection of contrast will be performed at inclusion and 2 years after inclusion
Imaging and radiotherapy data will be collected in parallel using the PediaRT software used in current practice collection of radiotherapy dosimetric data as well as standard MRI examinations pre-operatively post-operatively and at the 2-year and 4-year follow-up
130 patients will be included in this study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None