Assessment of Predicted LET and Dosimetry in Relation to White Matter Changes in Pediatric Patients Following Proton Therapy for Primary Central Nervous System and Base of Skull Malignancies: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- White matter changes within the central nervous system (CNS) following proton beam therapy using magnetic resonance imaging (MRI) sequences
研究概览
简要总结
This trial gathers information from patients with primary central nervous system or base of skull tumors that receive proton beam therapy and see if certain imaging techniques can help detect radiation-related changes over time. This study may help providers learn more about proton beam radiotherapy and how to improve the way it is delivered.
详细描述
PRIMARY OBJECTIVE:
I. To establish linear energy transfer (LET)-based models as early predictors for white matter changes on magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI) sequences in pediatric patients following proton beam therapy for primary central nervous system (CNS) and base of skull tumors.
OUTLINE:
Patients' medical charts are reviewed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed central nervous system of skull base tumors
- •Patient is going to undergo central nervous system (CNS) or base of skull proton beam therapy
排除标准
- •Patients who have received prior therapeutic radiotherapy to the primary brain tumor site
- •Patients who are unable to maintain follow-up through the Phoenix Children's Hospital and Mayo Clinic Arizona
结局指标
主要结局
White matter changes within the central nervous system (CNS) following proton beam therapy using magnetic resonance imaging (MRI) sequences
时间窗: At 18 months
The concordance of predicted linear energy transfer linear (LET) values with radiographic white matter changes will be analyzed utilizing a one sample t-test. Will the compare concordance over time to evaluate if there is an increase, utilizing repeated measures mixtures models.
Relative biological effectiveness (RBE) predictions
时间窗: Up to 18 months
Will compare concordance over time to evaluate if there is an increase, utilizing repeated measures mixtures models.
White matter changes within the CNS following proton beam therapy using diffusion tensor imaging (DTI) sequences
时间窗: At 18 months
The concordance of predicted LET values with radiographic white matter changes will be analyzed utilizing a one sample t-test. We will the compare concordance over time to evaluate if there is an increase, utilizing repeated measures mixtures models.
次要结局
- White matter changes identified on imaging, and predict concordance(Up to 18 months)
- White matter changes within the CNS following proton beam therapy using DTI and MRI(Up to 18 months)
- Dose-volume effect and predicted LET distribution(Up to 18 months)