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

Last updated: June 30, 2025
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Overall Status: Active - Recruiting

Phase

N/A

Condition

Human Papilloma Virus (Hpv)

Memory Loss

Brain Tumor

Treatment

Neurocognitive Testing

substructure informed planning

MRI

Clinical Study ID

NCT05658731
J2255
IRB00331759
  • Ages 1-26
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

  1. STRATUM A

  2. 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

  1. Exclusion Criteria

  • 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

  1. STRATUM B

  2. 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

  1. 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

  1. STRATUM C

  2. Eligibility Criteria

  • must be aged 5 to <26 years of age

  • must be able to complete research imaging without sedation

  1. Exclusion Criteria
  • must not have any major psychiatric, neurologic or medical diagnosis

Study Design

Total Participants: 338
Treatment Group(s): 3
Primary Treatment: Neurocognitive Testing
Phase:
Study Start date:
May 17, 2023
Estimated Completion Date:
December 31, 2035

Connect with a study center

  • Sibley Memorial Hospital

    Washington, District of Columbia 20016
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

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