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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
338
Radiation Therapy with substructure informed planning determined by the PI.
California Verbal Learning Test (CVLT) and other cognition assessments.
Magnetic resonance imaging (MRI) using whole brain diffusion tensor imaging (DTI) and resting state functional MRI (rsfMRI).
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
RECRUITINGJohns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGNumber 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.
Time frame: 1 month
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.
Time frame: up to 5 years after treatment
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.
Time frame: baseline to two years
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.
Time frame: baseline to 3 years
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.
Time frame: baseline to 5 years
characterize longitudinal CVLT scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation
Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.
Time frame: baseline to 5 years
characterize longitudinal NIH toolbox scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation
Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.
Time frame: baseline to 5 years
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