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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT05658731
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 26 Years
Healthy Volunteers
Accepted

Interventions

  • 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).

Study Details

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.

Key Dates

Start date
May 17, 2023
Status verified
Jun 2025
Primary completion
Dec 31, 2032
Completion
Dec 31, 2035

Study Design

Enrollment
338 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Sibley Memorial HospitalWashington D.C.District of Columbia20016-
Johns Hopkins HospitalBaltimoreMaryland21287-

Find similar trials in Washington D.C., DC

By condition
Brain cancerHead and neck cancer
By specialty
OncologyNeuro-oncologyENT
By research site
Sibley Memorial Hospital· Washington D.C., DCJohns Hopkins Hospital· Baltimore, MD

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