What this study is
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.
What's being tested
- Cognitive testing
Intervention · OTHER
NIH Toolbox Cognitive Battery and the Novel Cognitive Measure (NCM)
- Resting State MRI/Precision functional mapping
Intervention · DEVICE
At baseline (before the end of radiation therapy) and approximately 12 months after the completion of radiation therapy.
Study details
- Official title
- Assessing Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients
- Sponsor
- Washington University School of Medicine
- Conditions
- Brain Tumor, Primary
- Enrolling
- 16 people
- Starts
- 2024-07-10
- Est. completion
- 2027-07-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 8 Years – 21 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWashington University School of Medicine/Saint Louis Children's Hospital
St Louis, Missouri, United States
- Stephanie Perkins, M.D. · Contact314-747-4405sperkins@wustl.edu
- 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
Recruiting
Study team
Sponsor
Washington University School of Medicine
Study ID 202312104
Principal investigator
Stephanie Perkins, M.D.
Washington University School of Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.