NCT06185686 · Washington University School of Medicine
Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients
What this study is about
With modern therapy, the survival rate for pediatric brain tumor patients has significantly improved, with over 70% of patients surviving their disease. However, this progress often comes at the cost of substantial morbidity, with cognitive deficits being the primary obstacle to independent living.
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With modern therapy, the survival rate for pediatric brain tumor patients has significantly improved, with over 70% of patients surviving their disease. However, this progress often comes at the cost of substantial morbidity, with cognitive deficits being the primary obstacle to independent living. Robust predictors of cognitive decline and a comprehensive understanding of the underlying mechanisms of cognitive injury remain elusive. This study will prospectively investigate alterations in brain resting state networks following radiation therapy using functional imaging. The hypothesis is that radiation therapy leads to dose-dependent alterations in functional connectivity in the networks associated with higher level cognition, ultimately leading to cognitive decline.
Interventions
OTHER
Cognitive testing
NIH Toolbox Cognitive Battery and the Novel Cognitive Measure (NCM)
DEVICE
Resting State MRI/Precision functional mapping
At baseline (before the end of radiation therapy) and approximately 12 months after the completion of radiation therapy.
Primary outcome measures
Radiation induced effects on functional brain resting state connectivity
Time frame: Through 1 year follow-up
The investigators will compare resting state maps of each patient pre- and post-radiation therapy. The investigators will evaluate changes in the resting state architecture and compare to the average results that would be expected from a patient in the same age and sex.
Baseline characteristics of functional network architecture
Time frame: At baseline (day 1)
The investigators will assess the unique architecture of brain networks at diagnosis and how significantly this architecture diverges from average healthy controls.
Change in characteristics of functional network architecture
Time frame: Baseline and 1 year follow-up
The investigators will assess brain system segregation which is measure of the connection and disconnection between different brain networks. These will be compared within individuals and compared to healthy controls.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- St Louis, Missouri
Collaborators
United States Department of Defense, The Foundation for Barnes-Jewish Hospital, Children's Cancer Research Fund
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 18, 2025 · Source of record for eligibility and locations