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NCT Number: NCT05658731

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

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.

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Key information

Conditions

Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

1 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sibley Memorial Hospital, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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
  • treatment must include radiation therapy (either proton or photon)
  • patients must not have completed radiation therapy
  • 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
  • STRATUM B
  • 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
  • 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
  • STRATUM C
  • Eligibility Criteria
  • must be aged 5 to <26 years of age
  • must be able to complete research imaging without sedation
  • Exclusion Criteria
  • must not have any major psychiatric, neurologic or medical diagnosis

Treatment and study plan

substructure informed planning

Radiation

Radiation Therapy with substructure informed planning determined by the PI.

Neurocognitive Testing

Other

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

MRI

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Cumulative incidence of local and distant tumor recurrence

    Time frame: 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.

  2. Fractional anisotropy values

    Time frame: 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.

  3. 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.

    Time frame: baseline to 3 years

    Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.

  4. 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.

    Time frame: baseline to 5 years

    Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.

  5. characterize longitudinal CVLT scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation

    Time frame: baseline to 5 years

    Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.

  6. characterize longitudinal NIH toolbox scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation

    Time frame: baseline to 5 years

    Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.

Study contacts

Contact information is provided by the study sponsor or research team.

Katie Lowe

CONTACT

[email protected]

410-955-8652

Sahaja Acharya, MD

CONTACT

[email protected]

202-537-4788

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • Clark Charitable Foundation
  • United States Department of Defense

Registry information

Acronym: CogRT

Important dates

Study start
2023
Primary completion
2032
Study completion
2035
First posted
Dec 21, 2022
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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