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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 1 Year - 26 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05658731
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain Tumor, Head and Neck Cancer
Arms & Interventions

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

Radiation: - substructure informed planning

Radiation Therapy with substructure informed planning determined by the PI.

Other: - Neurocognitive Testing

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

Diagnostic Test: - MRI

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sibley Memorial Hospital, Washington, District of Columbia

Status

Recruiting

Address

Sibley Memorial Hospital

Washington, District of Columbia, 20016

Johns Hopkins Hospital, Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins Hospital

Baltimore, Maryland, 21287

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