Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients
Part of paid clinical trials in St Louis, Missouri.
- Sponsor
- Washington University School of Medicine
- Study ID
- NCT06185686
- Status
- Recruiting
Conditions
- Brain Tumor, Primary
Eligibility Criteria
- Sex
- ALL
- Age
- 8 Years - 21 Years
- Healthy Volunteers
- Not accepted
Interventions
- Cognitive testing — OTHERNIH 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.
Study Details
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.
Key Dates
- Start date
- Jul 10, 2024
- Status verified
- Jul 2025
- Primary completion
- Jul 31, 2027
- Completion
- Jul 31, 2027
Study Design
- Enrollment
- 16 participants (estimated)
Arms
- Arm: Brain tumor patients receiving proton radiation therapyPatients between 8 and 21 years old (inclusive) with a newly diagnosed primary brain tumor that will be treated with proton radiation therapy
Primary Outcome Measure
Radiation induced effects on functional brain resting state connectivity [ Time Frame: Through 1 year follow-up ]
Central Contacts
- Stephanie Perkins, M.D.314-747-4405
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Washington University School of Medicine/Saint Louis Children's Hospital | St Louis | Missouri | 63110 | Stephanie Perkins, M.D. (PRINCIPAL_INVESTIGATOR) Scott Marek, Ph.D. (SUB_INVESTIGATOR) Joshua Shimony, M.D., Ph.D. (SUB_INVESTIGATOR) Margaret Shatara, M.D. (SUB_INVESTIGATOR) |
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