Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Local Control Rate at 1 year
研究概览
简要总结
This is a feasibility study to determine the usefulness of a brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit lung cancer patients by reducing the radiation dose to critical structures, such as the heart wall, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.
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
- •Subject signed inform consent
- •Suspected or proven non-small cell lung cancer (NSCLC) in the upper lobes of the left or right lung
- •Pre-operative criteria
- •Lung nodule suspicious for NSCLC
- •Mass ≤ 7 cm in maximum diameter by CT scan of the chest and upper abdomen
- •Clinical stage I or Clinical stage II
- •Not pregnant or nursing
- •Negative pregnancy test in premenopausal women
- •Fertile patients must use effective contraception
- •More than 5 years since prior invasive malignancy unless non melanoma skin cancer or in-situ cancer
排除标准
- 未提供
研究组 & 干预措施
CivaSheet Directional LDR Brachytherapy
FDA Cleared CivaSheet directional Pd-103 Brachytherapy Source is a planar radiation source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.
干预措施: CivaSheet (Device)
结局指标
主要结局
Local Control Rate at 1 year
时间窗: 1 year
The local control rate in the region irradiated by CivaSheet.
次要结局
- Freedom from regional or distant recurrence(1 year)
- Toxicity graded on CTCAE 4.0 Scale(1 year)
- Time to recurrence(1 year)