NCT05323747已完成不适用
Clinical Protocol for the Prospective Evaluation of a Commercially Available Hydrogel Spacer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioProtect
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Dosimetry changes
研究概览
简要总结
Dosimetry efficacy evaluation of the hydrogel spacer
详细描述
Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in 20 males undergoing radiotherapy to treat prostate cancer. Study will utilize pre and post gel insertion CT images to determine the endpoints.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •At lease 18 years of age
- •Undergoing external beam or brachy radiation therapy with a hydrogel spacer
排除标准
- •Invasive adenocarcinoma that is extracapsular and demonstrates posterior extension
结局指标
主要结局
Dosimetry changes
时间窗: 1 month
Assessment of rectal radiation exposure as compared between rectal dose volume histograms calculated for pre and post Hydrogel Injection
次要结局
- Prostate to rectum spacing(1 month)
研究者
研究点 (2)
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