About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Treated at Siteman Cancer Center at Washington University School of Medicine.
Trial design
Cohort
Prospective
Treatments tested in this trial
Cognitive testing
Other interventionNIH Toolbox Cognitive Battery and the Novel Cognitive Measure (NCM)
Resting State MRI/Precision functional mapping
DeviceAt baseline (before the end of radiation therapy) and approximately 12 months after the completion of radiation therapy.
Treatment groups
Trial outcomes
Primary outcomes
Radiation induced effects on functional brain resting state connectivity
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
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
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.
Secondary outcomes
Correlation of radiation dose to changes in cognitive performance and resting state network connectivity
In an exploratory fashion, the investigators will evaluate the dose of radiation received to each resting state network to determine if functional connectivity changes in a dose dependent manner at 1 year.
Sponsors and contacts
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Washington University School of Medicine
Lead sponsor
United States Department of Defense
Collaborator
The Foundation for Barnes-Jewish Hospital
Collaborator
Children's Cancer Research Fund
Collaborator