Imaging Biomarkers to Predict Responsiveness to Tumor Treating Fields in Patients With High Grade Glioma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Progression of disease
研究概览
简要总结
Patients with glioblastoma, an aggressive brain tumor, are recommended to undergo treatment with tumor treating fields using the Optune device as part of standard of care therapy. While undergoing treatment, patients are monitored regularly with brain MRI scans to look for tumor progression, but there are currently no means to predict which, or when, patients will progress. The purpose of the current study is to prospectively analyze these MRI scans to look for subtle imaging markers that can predict for future brain tumor progression while undergoing tumor treating field therapy.
详细描述
The proposed trial involves the prospective collection of imaging data at standard clinical time points before and during treatment with TTFields. All patients who are offered treatment with TTFields will also be offered enrollment in this non-randomized, observational study. Imaging data will include the standard battery of MRI sequences, which includes DWI and ADC reconstruction. These data will be collected at standard time points and the proposed study will not rely on any additional imaging or tests outside of the clinical standard of care.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18 or older with newly diagnosed WHO grade IV glioblastoma or patients with recurrent glioblastoma not previously treated with TTFields.
- •Patients may have undergone surgical resection or biopsy.
- •Residual tumor, absence of treatment with temozolomide or radiation therapy will not be an exclusion criteria for the study.
排除标准
- •Patients previously treated with TTFields will not be included in the study.
- •Patients will also be excluded if they are undergoing active treatment with systemic agents, including bevacizumab, during treatment with TTFields.
结局指标
主要结局
Progression of disease
时间窗: Until discontinuation of tumor treating fields, progression or death. This will be evaluated by imaging and clinical exam from the time of trial enrollment until up to 36 months at approximately three-month intervals.
Clinical or radiographic disease progression
次要结局
未报告次要终点
研究者
Theodore Yanagihara
Assistant Professor of Clinical Radiation Oncology
New York Presbyterian Brooklyn Methodist Hospital