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

Johns Hopkins Medicine

Status: Enrolling

Conditions: Brain Tumor; Head and Neck Cancer

Treatments: Diagnostic Test: MRI; Other: Neurocognitive Testing; Radiation: substructure informed planning

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05658731

IRB00331759 (Other Identifier)

J2255

Details and patient eligibility

About

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.

Enrollment: 338 estimated patients

Sex: All

Ages: 1 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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338 participants in 3 patient groups

Stratum A (new diagnosis, substructure informed radiation therapy)

Experimental group

Description:

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

Treatment:

Other: Neurocognitive Testing

Radiation: substructure informed planning

Diagnostic Test: MRI

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

Other group

Description:

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

Treatment:

Other: Neurocognitive Testing

Diagnostic Test: MRI

Stratum C (healthy controls matched to Stratum A)

Other group

Description:

Healthy patients who are matched to Stratum A patients

Treatment:

Diagnostic Test: MRI