Actively Recruiting
Assessing Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients
Led by Washington University School of Medicine · Updated on 2025-07-18
16
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying pediatric patients aged 8 to 21 years with newly diagnosed primary brain tumors who will receive proton radiation therapy. The study aims to investigate how radiation therapy affects brain resting state networks using functional imaging, focusing on dose-dependent changes in brain connectivity that may lead to cognitive decline. This research addresses the challenge of cognitive deficits, a major barrier to independent living for survivors despite improved survival rates. Participants will undergo proton radiation therapy for their brain tumors. The study includes cognitive testing using the NIH Toolbox Cognitive Battery and the Novel Cognitive Measure. Functional brain imaging with resting state MRI will be performed at baseline before the end of radiation therapy and again about 12 months after completing treatment. This observational study monitors changes in brain network architecture over time. During the study, participants will complete cognitive assessments and MRI scans to evaluate brain function and connectivity. Researchers will measure radiation-induced effects on brain resting state networks at baseline and one year later, correlating these changes with cognitive performance. The study requires follow-up for one year to assess these outcomes. Participants must be able to consent or assent and have a life expectancy of at least one year. Safety is monitored by excluding those with contraindications to MRI or requiring sedation for scans.
CONDITIONS
Brief Title
Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 8 and 21 years of age, inclusive
- Newly diagnosed primary brain tumor of any location and any histology that will be treated with proton radiation therapy
- Life expectancy of at least one year
- Able to understand and willing to consent or assent to the research proposed (or that of a legally authorized representative, if applicable), along with consent of legal guardian(s) if applicable
You will not qualify if you...
- Presence of visual impairment to an extent that the patient is unable to complete the computer testing
- Contraindication to MRI scan (i.e. due to cardiac pacemaker)
- Presence of programmable shunt or dental braces
- Requires sedation for MRI scans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the end of radiation therapy
Participants undergo cognitive testing and resting state MRI before the end of radiation therapy to assess baseline brain network function.
1 baseline visit (in-person)
Duration - Approximately 12 months after radiation therapy completion
Participants are followed up approximately 12 months after radiation therapy with cognitive testing and resting state MRI to assess changes in brain network connectivity and cognitive performance.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine/Saint Louis Children's Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
S
Stephanie Perkins, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here