RecruitingNot ApplicableNCT05658731

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


Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

338 participants

Start Date

May 17, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 26 Years

Plain Language Summary

Simplified for easier understanding

This study tracks how radiation therapy affects thinking and memory in children, teenagers, and young adults who have brain tumors, to help doctors better understand and minimize long-term cognitive side effects of radiation to the brain. **You may be eligible if...** - You are between 1 and 25 years old with a brain or skull-base tumor (including tumors near the nose or eyes) - You are about to start radiation therapy OR you previously had brain radiation before age 26 and it has been less than 10 years since your last radiation - You have not yet finished your current course of radiation **You may NOT be eligible if...** - You are pregnant - You are unable to complete cognitive (thinking/memory) tests — including children who don't understand English or have pre-existing neurological/developmental disorders such as Down syndrome or autism Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONsubstructure informed planning

Radiation Therapy with substructure informed planning determined by the PI.

OTHERNeurocognitive Testing

California Verbal Learning Test (CVLT) and other cognition assessments.

DIAGNOSTIC_TESTMRI

Magnetic resonance imaging (MRI) using whole brain diffusion tensor imaging (DTI) and resting state functional MRI (rsfMRI).


Locations(2)

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

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NCT05658731


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