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.
STRATUM A
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
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
STRATUM B
Eligibility Criteria
Parallel
substructure informed planning
RadiationRadiation Therapy with substructure informed planning determined by the PI.
Neurocognitive Testing
Other interventionCalifornia Verbal Learning Test (CVLT) and other cognition assessments.
MRI
Diagnostic testMagnetic resonance imaging (MRI) using whole brain diffusion tensor imaging (DTI) and resting state functional MRI (rsfMRI).
Number of plans that meet substructure-informed planning constraints
Number of plans that meet substructure-informed constraints (per protocol) divided by the total number of plans.
Cumulative incidence of local and distant tumor recurrence
Calculate the cumulative incidence of local and distant tumor recurrence. Local and tumor recurrence is determined by imaging and clinical symptoms.
Fractional anisotropy values
This outcome will measure changes in connection strength within brain networks. Fractional anisotropy values range from 0 to 1. Higher numbers are better.
compare the change in California Verbal Learning Test (CVLT) in patients whose radiation plans meet the dose constraints compared to those who do not for all patients in Stratum A.
Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.
compare the change in NIH toolbox scores in patients whose radiation plans meet the dose constraints compared to those who do not for all patients in Stratum A.
Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
United States Department of Defense
Collaborator
Clark Charitable Foundation
Collaborator
