Microwave Radiometry for the Diagnosis and Monitoring of Breast Cancer
Microwave Radiometry for the Diagnosis and Monitoring of Breast Cancer
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).
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.

 It was shown that the device can be used for detection of carotid temperature abnormalities
 and the temperature of the carotid is a good correlation to the risk of stroke in the
 patient.

 Today it is technically possible to obtain non-invasively the information concerning thermal
 activity of the tumor and use this information for the prediction of individual therapies and
 monitoring the efficacy of breast cancer treatment.

 The clinical trials in Russia show that tumors with a low degree of malignancy have low
 temperature changes and the tumor with high degree of malignancy have high temperature
 changes.

 Seven clinical trials of (RTM-01-RES) with 1000 patients have shown that 90% of breast
 malignant tumours have substantial temperature changes (the sensitivity is 85%-95%,
 specificity 56%-75%).

 The standard of care for patients with malignant tumors of the breast is to use microwave
 radiometry and this is recommended by leading Russian mammalogists in the National guidelines
 of breast care.

 Given that the temperature of a malignant tumor is higher than a benign lesion and that the
 temperature of more proliferative and thus poorer outlook cancers is greater than less
 proliferative cancers, the aim is whether with the most up to date technology these
 temperatures can be measured accurately on the skin.

 The benefits of such a device would be

 1. Diagnostic - to help differentiate benign from malignant lesions.

 2. Prognostic - to provide insight into the proliferation rate using a non-invasive test.

 3. Predictive of benefit - to show that changes in temperature predate changes in tumors
 volume in patients treated with drug therapy initially.

 The investigation is non-invasive. If it were possible to demonstrate benefit, then this
 simple non-invasive test could have a useful role in assessing patients with breast lumps and
 in particularly breast cancer.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  Patients unable to give written informed consent.

 -  Patients not having appropriate imaging (mammography +/- ultrasound).