Clinical trial · Interventional
Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this trial is to determine whether it is possible to minimize radiation dose to parts of the brain that are important for thinking and learning in children who require radiation to treat their tumor, and if this will help reduce neurocognitive (thinking and learning) impairments in these patients. Patients with newly diagnosed brain or head and neck tumors who are having radiation therapy will have neurocognitive testing and MRI imaging (both research and for regular care) done as part of their participation in the study. Survivors of childhood brain tumors who completed radiation therapy at least two years before joining the study, and have not had a recurrence, will have neurocognitive testing and research MRIs completed. Healthy children will also be enrolled and have research MRIs done. The researchers will use the radiation plan to determine how much radiation was delivered to different parts of the brain. The investigators will use the MRIs to determine how the normal brain is changing after treatment; and how this compares to patients who had standard radiation treatment or who never had a brain tumor. The neurocognitive testing will be compared among different groups to see how different treatment plans affect performance on neurocognitive tests.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Diagnostic Test | — | UNRESOLVED |
| Neurocognitive Testing | Other | — | UNRESOLVED |
| substructure informed planning | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Stratum A (new diagnosis, substructure informed radiation therapy)
- description
- Patients will undergo radiation therapy which has been planned according to dose constraints to specific brain substructures.
- interventionNames
- Radiation: substructure informed planning
- Other: Neurocognitive Testing
- Diagnostic Test: MRI
- type
- OTHER
- label
- Stratum B (patients ≥ 2 years after standard radiation therapy)
- description
- Patients who completed radiation therapy under standard planning procedures ≥ 2 years ago.
- interventionNames
- Other: Neurocognitive Testing
- Diagnostic Test: MRI
- type
- OTHER
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 26 Years
Show eligibility criteria text
1. STRATUM A
1. Eligibility Criteria
* aged 1 to \<26 years of age
* tumor must be located in the brain or adjacent to the brain including but not limited to nasopharynx, paranasal sinuses and orbit
* treatment must include radiation therapy (either proton or photon)
* patients must not have completed radiation therapy
2. Exclusion Criteria
* pregnancy
* patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism
2. STRATUM B
1. Eligibility Criteria
* diagnosed with a brain tumor at \<26 years of age
* received radiation to the brain as part of therapy
* time from radiation start to study enrollment is ≥ 2 years
* there has not been disease recurrence from time of most recent radiation treatment to study enrollment
2. Exclusion Criteria
* patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism
3. STRATUM C
1. Eligibility Criteria
* must be aged 5 to \<26 years of age
* must be able to complete research imaging without sedation
2. Exclusion Criteria
* must not have any major psychiatric, neurologic or medical diagnosisReferences
Publications (0)
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