NCT05658731 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
(CogRT)
What this study is about
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.
View original scientific description
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.
Interventions
RADIATION
substructure informed planning
Radiation Therapy with substructure informed planning determined by the PI.
OTHER
Neurocognitive Testing
California Verbal Learning Test (CVLT) and other cognition assessments.
DIAGNOSTIC_TEST
MRI
Magnetic resonance imaging (MRI) using whole brain diffusion tensor imaging (DTI) and resting state functional MRI (rsfMRI).
Primary outcome measures
Number of plans that meet substructure-informed planning constraints
Time frame: 1 month
Number of plans that meet substructure-informed constraints (per protocol) divided by the total number of plans.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
- 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
- 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
- Eligibility Criteria
- must be aged 5 to \<26 years of age
- must be able to complete research imaging without sedation
- must not have any major psychiatric, neurologic or medical diagnosis
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
- 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
- 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
- Eligibility Criteria
- must be aged 5 to \<26 years of age
- must be able to complete research imaging without sedation
- must not have any major psychiatric, neurologic or medical diagnosis
Where
- Washington D.C., District of Columbia
- Baltimore, Maryland
Collaborators
United States Department of Defense, Clark Charitable Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations