Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
- Conditions
- Head and Neck CancerBrain Tumor
- Interventions
- Radiation: substructure informed planningDiagnostic Test: MRIOther: Neurocognitive Testing
- Registration Number
- NCT05658731
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 338
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stratum B (patients ≥ 2 years after standard radiation therapy) MRI Patients who completed radiation therapy under standard planning procedures ≥ 2 years ago. Stratum A (new diagnosis, substructure informed radiation therapy) Neurocognitive Testing Patients will undergo radiation therapy which has been planned according to dose constraints to specific brain substructures. Stratum A (new diagnosis, substructure informed radiation therapy) MRI Patients will undergo radiation therapy which has been planned according to dose constraints to specific brain substructures. Stratum B (patients ≥ 2 years after standard radiation therapy) Neurocognitive Testing Patients who completed radiation therapy under standard planning procedures ≥ 2 years ago. Stratum C (healthy controls matched to Stratum A) MRI Healthy patients who are matched to Stratum A patients Stratum A (new diagnosis, substructure informed radiation therapy) substructure informed planning Patients will undergo radiation therapy which has been planned according to dose constraints to specific brain substructures.
- Primary Outcome Measures
Name Time Method Number of plans that meet substructure-informed planning constraints 1 month Number of plans that meet substructure-informed constraints (per protocol) divided by the total number of plans.
- Secondary Outcome Measures
Name Time Method Cumulative incidence of local and distant tumor recurrence up to 5 years after treatment Calculate the cumulative incidence of local and distant tumor recurrence. Local and tumor recurrence is determined by imaging and clinical symptoms.
characterize longitudinal NIH toolbox scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation baseline to 5 years Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.
characterize longitudinal CVLT scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation baseline to 5 years Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores 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. baseline to 3 years Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.
Fractional anisotropy values baseline to two years 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 NIH toolbox scores in patients whose radiation plans meet the dose constraints compared to those who do not for all patients in Stratum A. baseline to 5 years Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.
Trial Locations
- Locations (2)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States