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

NCT ID: NCT05658731

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-17
• Study Completion Date: 2035-12-31

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

substructure informed planning

Intervention Type: RADIATION

Radiation Therapy with substructure informed planning determined by the PI.

Neurocognitive Testing

Intervention Type: OTHER

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

MRI

Intervention Type: DIAGNOSTIC_TEST

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

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

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

Group Type: OTHER

Neurocognitive Testing

Intervention Type: OTHER

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

MRI

Intervention Type: DIAGNOSTIC_TEST

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

Stratum C (healthy controls matched to Stratum A)

Healthy patients who are matched to Stratum A patients

Group Type: OTHER

MRI

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

substructure informed planning

Radiation Therapy with substructure informed planning determined by the PI.

Intervention Type: RADIATION

Neurocognitive Testing

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

Intervention Type: OTHER

MRI

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• 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

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Clark Charitable Foundation

UNKNOWN

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sahaja Acharya, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sibley Memorial Hospital

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

Site Status: RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sahaja Acharya, MD

Role: CONTACT

sachary7@jhmi.edu

202-537-4788

Katie Lowe

Role: CONTACT

katielowe@jhmi.edu

410-955-8652

Other Identifiers

IRB00331759

Identifier Type: OTHER

Identifier Source: secondary_id

J2255

Identifier Type: -

Identifier Source: org_study_id