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Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients

RecruitingNAAges 1 Year - 26 YearsAllSidney Kimmel Comprehensive Cancer Center at John…
NCT05658731 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 de

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📋 Eligibility rules (as published)
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 diagnosis
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What it tests

  • substructure informed planning
  • Neurocognitive Testing
  • MRI
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Where

2 sites
Sibley Memorial Hospital
Washington D.C., United States
Johns Hopkins Hospital
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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