Implantation of Markers for the Radiotherapy of Lung Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Positional reliability of markers
研究概览
简要总结
This clinical trial studies imaging markers in planning radiation therapy in patients with lung cancer. Implanting markers in the tumor that can be seen using imaging procedures during radiation therapy may allow x-rays to be sent directly to the tumor and cause less damage to normal tissue.
详细描述
OBJECTIVES:
- To acquire experience in the marker implantation process for mediastinal lymph nodes and primary lung tumors in patients with stage I-IIIB non-small cell lung cancer.
- To characterize the potential side effects involved in the use of markers in these patients.
- To analyze the positional stability of lung markers in these patients over a radiotherapy series.
- To acquire experience in the use of markers for treatment planning and radiotherapy in these patients.
OUTLINE: Patients undergo implantation of ≥ 1 small radio-opaque Visicoil™ marker into or close to the primary lesion and affected lymph nodes by bronchoscopy. Patients then undergo x-rays to document marker location, detect potentially dropped markers, and diagnose operation-related side effects (i.e., pneumothorax). After marker implantation, patients undergo stereotactic or conventionally fractionated radiotherapy for 30-33 daily fractions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Positional reliability of markers
时间窗: Up to 5 years
Number of dropped markers
时间窗: up to 5 years
Visibility of markers on CT and x-rays
时间窗: up to 5 years
Marker misplacements
时间窗: up to 5 years
Implantation-related side effects
时间窗: up to 5 years
Usability for patient treatment
时间窗: up to 5 years
次要结局
未报告次要终点