Early Detection of Breast Disease Using Medical Radiometer - RTM - 01 - RES
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Testing the sensitivity of the Microwave Thermography RTM-01-RES (ability to detect hotspots in breast lesions)
研究概览
简要总结
Medical Radiometer depends on detecting the microwaves that radiates from deep structure hot objects in the body. When it comes to the breast, causes of deep structure hot spots are numerous, it can be inflammatory, hormonal or neoplastic. Therefore, the primary objective of this study is to test the sensitivity of the Medical Radiometer in detecting the hot spots in the breast.
详细描述
Several pathological lesions and physiological changes can cause spot in the breast to show higher temperature than it should be.
The causes can be:
[I] Physiological: During menarch, puberty, menstruation, lactation and after sexual Intercourse.
[II] Inflammatory: Mastitis and breast Abscess. [III] Endocrinal: any cause of increasing Oestrogen, Prolactin and/or Thyroid hormones.
[IV] Neoplastic: the neo-Vascularisation of the malignant tumors. Radiometer is a machine that can detect through its sensitive probe the microwave that radiate from the deep structures in the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The perfect sample should be 2000 females or more.
- •50 % already diagnosed breast cancer of any type
- •30% normal thought to be healthy females.
- •10% lactating
- •10% different breast diseases
排除标准
- •Menstruating females.
结局指标
主要结局
Testing the sensitivity of the Microwave Thermography RTM-01-RES (ability to detect hotspots in breast lesions)
时间窗: 6 months
Ability of the Microwave Thermography RTM-01-RES to detect hotspots in the various breast lesions.
次要结局
- Study the Temperature pattern(3 months)