NCT01706016已完成2 期
Local Treatment by Thermic Destruction of Primitive Breast Cancer. Phase II: Feasibility and Effectiveness, Standardization of Procedures.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 6
- 主要终点
- Effectiveness of laser treatment
研究概览
简要总结
Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Noninflammatory unilateral and unifocal breast cancer
- •Size </= 20mm (ultrasound measure)
- •Histological confirmation of cancer by biopsy grade status hormone and HER
- •Good delineation of the lesion on ultrasound.
- •Minimum distance of 5 mm between the tumor and the skin between the tumor and muscle.
- •Age between 18 and 80
- •ECOG performance status 0 or 1
排除标准
- 未提供
研究组 & 干预措施
Patients with breast cancer smaller than 20mm
Experimental
干预措施: Thermic destruction of tissue by Laser using the Novilase device (Procedure)
结局指标
主要结局
Effectiveness of laser treatment
时间窗: 28 days after initial diagnosis
Destruction of the carcinoma will be assess by histological analysis of the specimen. If more than 10% of viables cancerous cells are remaining in the volume treated by laser, the procedure would be a fail
次要结局
- Life quality(D-0 and before the surgery)
研究者
研究点 (6)
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