Assessing Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Radiation induced effects on functional brain resting state connectivity
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Radiation induced effects on functional brain resting state connectivity
时间窗: Through 1 year follow-up
The investigators will compare resting state maps of each patient pre- and post-radiation therapy. The investigators will evaluate changes in the resting state architecture and compare to the average results that would be expected from a patient in the same age and sex.
Baseline characteristics of functional network architecture
时间窗: At baseline (day 1)
The investigators will assess the unique architecture of brain networks at diagnosis and how significantly this architecture diverges from average healthy controls.
Change in characteristics of functional network architecture
时间窗: Baseline and 1 year follow-up
The investigators will assess brain system segregation which is measure of the connection and disconnection between different brain networks. These will be compared within individuals and compared to healthy controls.
次要结局
- Correlation of radiation dose to changes in cognitive performance and resting state network connectivity(At 1 year follow-up)