Recruiting

Observational Study

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT05658731

Conditions

Brain Tumor

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 1 - 26

Healthy Volunteers: Accepted

Interventions

substructure informed planning

Neurocognitive Testing

MRI

Study Details

Brief 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.

Conditions

Brain Tumor

Head and Neck Cancer

Study ID

NCT05658731

Start date

May 17, 2023

Status verified date

Jun, 2026

Completion date

Dec, 2035

Anticipated

Primary completion date

Dec, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 26

Healthy Volunteers: Accepted

1. STRATUM A

1. 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
2. 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
2. STRATUM B

1. 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
2. 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
3. STRATUM C

1. Eligibility Criteria

  • must be aged 5 to <26 years of age
  • must be able to complete research imaging without sedation
2. Exclusion Criteria

  • must not have any major psychiatric, neurologic or medical diagnosis

Study Design

Enrollment

338 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stratum A (new diagnosis, substructure informed radiation therapy)

Patients will undergo radiation therapy which has been planned according to dose constraints to specific brain substructures.

other: Stratum B (patients ≥ 2 years after standard radiation therapy)

Patients who completed radiation therapy under standard planning procedures ≥ 2 years ago.

other: Stratum C (healthy controls matched to Stratum A)

Healthy patients who are matched to Stratum A patients

Interventions

substructure informed planning

Radiation Therapy with substructure informed planning determined by the PI.

Neurocognitive Testing

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

MRI

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

Primary outcome measure

  • Number of plans that meet substructure-informed planning constraints [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Sahaja Acharya, MD

202-537-4788sachary7@jhmi.edu

Katie Lowe

410-955-8652katielowe@jhmi.edu

Locations

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • radiation therapy
  • pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-06-29.