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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Diagnostic test, Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 26
Healthy Volunteers: t
View:

∙ STRATUM A

• 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

Locations
United States
Washington, D.c.
Sibley Memorial Hospital
RECRUITING
Washington D.c.
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Contact Information
Primary
Sahaja Acharya, MD
sachary7@jhmi.edu
202-537-4788
Backup
Katie Lowe
katielowe@jhmi.edu
410-955-8652
Time Frame
Start Date: 2023-05-17
Estimated Completion Date: 2035-12
Participants
Target number of participants: 338
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense, Clark Charitable Foundation
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

This content was sourced from clinicaltrials.gov