NCT04480645已完成早期 1 期
CivaDerm(TM) Surface Therapy Pilot Study
CivaTech Oncology1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年5月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- skin toxicity events
研究概览
简要总结
This is a pilot study to determine the usefulness of new brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit basal cell and squamous cell carcinoma patients by providing conformal radiation therapy to the surface of the skin.
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 informed consent
- •Confirmed superficial or nodular basal cell or squamous cell carcinoma
- •Biopsy proven on chest, stomach, back, arms, legs, feet (trunk and extremities)
- •>5 mm of residual tumor
- •tumors < 3 cm
- •Capable of complying with Patient Release Instructions
排除标准
- •Is unable or unwilling to comply with the protocol requirements
- •Pregnant or breast feeding
- •Metastases
结局指标
主要结局
skin toxicity events
时间窗: within 2 months of treatment
grade 3+ events
次要结局
- dose delivered to target(1 week)
研究者
研究点 (1)
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