Assessing brain function in children with CNS tumors receiving proton therapy
Computer-based Neurocognitive Assessment in Children With Central Nervous System Tumors Receiving Proton Beam Radiation Therapy
This study is testing how proton therapy affects the thinking and learning abilities of children with brain tumors by checking their cognitive skills before and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 4 Years to 21 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT02559752 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate neurocognitive performance in pediatric patients diagnosed with central nervous system tumors who are undergoing proton beam radiation therapy (PBRT). The researchers will conduct baseline neurocognitive assessments before the first week of radiation and follow-up evaluations 6-12 months post-treatment, with annual assessments thereafter. The goal is to analyze how factors such as age at diagnosis, tumor location, and radiation dose influence cognitive outcomes. This study addresses a significant gap in prospectively-collected data regarding the effects of PBRT on cognitive function in children.
Who should consider this trial
Good fit: Ideal candidates include children aged 4 to 21 years with a diagnosis of primary CNS tumors or metastatic disease to the CNS who are expected to survive for more than one year.
Not a fit: Patients with secondary health conditions affecting cognitive functioning or those unable to participate in computer-based testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into how proton therapy impacts cognitive outcomes in children, potentially leading to improved treatment protocols.
How similar studies have performed: While modeling studies suggest that PBRT may enhance cognitive outcomes, this study is among the first to prospectively collect patient data on this topic.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of primary CNS tumor or diagnosis of metastatic disease to the CNS with an expected overall survival of \> 1 year. Any prior treatment (chemo, XRT, or surgery) is allowed. * Planning to receive PBRT to treat the CNS tumor. Patients who have already received PBRT for this disease may also be enrolled provided they completed the NIH Toolbox Cognitive Battery prior to the first week of radiation therapy. * Between 4 and 21 years of age (inclusive). * Life expectancy of at least one year. * Absence of visual impairment that would impede computer testing. * No secondary health conditions that would impact cognitive functioning (e.g. psychiatric or developmental disability unrelated to cancer). * Able to understand and willing to sign IRB-approved written informed consent document (or signature of legally authorized representative).
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie Perkins, M.D. — Washington University School of Medicine
- Study coordinator: Stephanie Perkins, M.D.
- Email: sperkins@wustl.edu
- Phone: 314-747-4405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.