Microwave Radiometry for the Diagnosis and Monitoring of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Sensitivity of the RTM device
研究概览
简要总结
A malignant tumor has higher temperature than normal tissue and the temperature of the tumor is dependent on the tumor growth rate. Thus tumor temperature is the universal indicator of tumor activity.
The temperature changes begin in the stage of atypical hyperplasia and increased proliferation and this opens up the possibilities for detection of patients with high risk lesions.
Microwave radiometer (RTM-01-RES) allows measurement of temperature changes of internal tissue at the depth of several centimetre and allows visualization of the temperature on the thermogram and temperature field.
It is noninvasive and the measurement of internal temperature is based on receiving natural electromagnetic radiation from the tissue in the gigahertz (GHz) frequency range. The device is absolutely harmless and has no risk because it does not emit any radiation. It can be used repeatedly as a method of monitoring.
Microwave radiometry has successfully completed seven clinical trials of more than 1000 patients in different countries. Microwave device (RTM-01-RES) is used in more than 300 medical centers in 30 countries.
Medical technology of microwave radiometry is included in the nomenclature of medical services in the Russian Federation, the Ministry of Health and is part of the standard of care for patients with malignant tumors of the breast.
This method of microwave radiometry is recommended by leading Russian mammalogists in the National guidelines of breast care.
The investigators would like to use the device in clinics in Scotland and later United Kingdom (UK) for breast diagnosis and monitoring treatment.
During 3 months the investigators aim to examine 150 patients with breast cancer and 150 patients without cancer who will be the control group. The results of temperature measurement will be compared with the results of histology, in particular, tumour cellulants p53 expression and other gene expression data for metabolic biomarkers and other tumor indicator. Statistical analysis of data will be performed. The device and initial training will be provided by RES Company (device producer).
详细描述
The temperature of a malignant tumour is a universal indicator of the growth rate of the tumor.
Tumor temperature can be used as a prediction of the benefit of individual therapies and in monitoring the efficacy of breast cancer treatment.
The temperature of tissue around a malignant tumour is correlated with micro vessel density (MVD) - the main indicator of angiogenesis.
A traditional infrared camera allows measurement of the temperature of the skin and the breast tumor at a depth of several centimetres.
It is well known that it is possible to detect thermal abnormality of internal tissues with the help of measuring the natural electromagnetic radiation in microwave frequency range. Microwave radiometer (RTM-01-RES) allows one to measure noninvasively any temperature changes of internal tissue at the depth of several centimetres and visualize the internal temperature on the thermogram and temperature field.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients attending the breast clinic undergoing mammography and/or ultrasound who can give written informed consent.
- •The investigators aim to recruit 150 patients likely to have breast cancer clinically and 150 patients who have normal breasts/benign abnormalities.
排除标准
- •Patients unable to give written informed consent.
- •Patients not having appropriate imaging (mammography +/- ultrasound).
结局指标
主要结局
Sensitivity of the RTM device
时间窗: Results obtained from the RTM device will be compared with those obtained by conventional diagnostic techniques at 6 months.
次要结局
- Predictability of the method(Results obtained from the RTM device will be compared with those obtained by conventional diagnostic techniques at 6 months.)