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Irradiation in Paediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention

Study acronym: IPANEMA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary endpoints: details revised at 1 of 1 entry
    • Study sites: 15 to 14
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 1 of 5 entries
  2. Minor Site details revised at 2 of 15 sitesv13
  3. Minor Site details revised at 2 of 15 sitesv12
  4. Minor Site details revised at 1 of 15 sitesv11
  5. Minor Study sites: 17 to 15v10
Show 8 earlier versionsHide 8 earlier versions
  1. Minor Site details revised at 1 of 17 sitesv9
  2. Minor Site details revised at 1 of 17 sitesv8
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 16 to 17
    • Primary and study completion dates: Sep 2030 to Oct 2030
    • Start date changed from estimate of Sep 2025 to Oct 21, 2025
    v7
  4. Minor Eligibility criteria expanded, about 15 words
    • Site contacts updated at 1 of 16 sites
    v6
  5. Notable Primary and study completion dates: Dec 2029 to Sep 2030
    • Start date: Apr 2025 to Sep 2025
    v5
  6. Notable Start date: Feb 2025 to Apr 2025v4
  7. Notable Start date: Dec 2024 to Feb 2025v3
  8. Notable Start date: Oct 2024 to Dec 2024
    • Primary and study completion dates: Oct 2029 to Dec 2029
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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, i.e. 2 years after the end of radiotherapy treatment, * And a second assessment 2 years after patient inclusion, i.e. 4 years after the end of radiotherapy treatment. A retrospective assessment of the patient's 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.
Trial Details
NCT Number NCT06599879
Lead Sponsor Institut Claudius Regaud
Conditions
(from sponsor)
Brain Tumor, Pediatric
Related terms Brain Neoplasms
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov