A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma (First in Man)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Reduction in Tumor size
研究概览
简要总结
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device.
详细描述
This will be a prospective, first in man, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.
This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.
Lesions with histopathological diagnosis of squamous cell carcinoma will be studied.
Reduction in tumor size 30 days after DaRT insertion will be assessed.
Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).
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
- •Histopathological confirmation of squamous cell carcinoma.
- •Tumor size ≤ 5 centimeters in the longest diameter.
- •Women of childbearing potential will have evidence of negative pregnancy test.
- •Life expectancy of more than 6 months.
- •Performance status 2 (ECOG scale) or less.
- •Signed informed consent form.
排除标准
- •Tumor maximal diameter > 5 centimeters.
- •Tumor of Keratoacanthoma histology.
- •Performance status ≥ 3 (ECOG scale).
- •Patients with moribund diseases, autoimmune diseases or vasculitis.
- •Patients under immunosuppressive and/or corticosteroid treatment.
- •Volunteers that participated in other studies in the past 30 days.
结局指标
主要结局
Reduction in Tumor size
时间窗: 30-45 days post seed insertion
The reduction in tumor size 30-45 days after DaRT insertion
Adverse Events
时间窗: 30-45 days post seed insertion
The incidence, severity and frequency of all Adverse Events
次要结局
- Percent of NecroticTissue(30-45 days post seed insertion)