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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 8 Years and 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Brain tumor patients receiving proton radiation therapy Patients between 8 and 21 years old (inclusive) with a newly diagnosed primary brain tumor that will be treated with proton radiation therapy
  • 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.
    Other names:
    • RSFC MRI

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine/Saint Louis Children's Hospital
St Louis 4407066, Missouri 4398678 63110
Contact:
Stephanie Perkins, M.D.
314-747-4405
sperkins@wustl.edu

More Details

NCT ID
NCT06185686
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Stephanie Perkins, M.D.
314-747-4405
sperkins@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.