Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive testing, Resting State MRI/Precision functional mapping.
- Who it may be relevant to
- Registry conditions: Brain Tumor, Primary. Basic parameters: 8 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients
Overview
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.
Interventions
- 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.
Primary outcome measures
- Radiation induced effects on functional brain resting state connectivity [Time frame: Through 1 year follow-up]
- Baseline characteristics of functional network architecture [Time frame: At baseline (day 1)]
- Change in characteristics of functional network architecture [Time frame: Baseline and 1 year follow-up]
Secondary outcome measures (1)
- Correlation of radiation dose to changes in cognitive performance and resting state network connectivity [Time frame: At 1 year follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Washington University School of Medicine/Saint Louis Children's Hospital — St Louis
Identifiers
NCT: NCT06185686 · 202312104