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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-26
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About this trial

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

Qualifiers

STRATUM A

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

Disqualifiers

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

STRATUM B

Eligibility Criteria

Trial design

Treatments tested in this trial

  • substructure informed planning
  • Neurocognitive Testing
  • MRI

Treatment groups

338 Participants
are divided into 3 treatment groups

Locations

2
Sibley Memorial Hospital20016, Washington D.C.District of Columbia, United States
Johns Hopkins Hospital21287, BaltimoreMaryland, United States

Sponsors and collaborators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

United States Department of Defense

Collaborator

Clark Charitable Foundation

Collaborator