Clinical trial · Observational
Microwave Radiometry for the Diagnosis and Monitoring of Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No funding
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RTM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Temperature measured by RTM device
- description
- Both the internal temperature and skin temperature will be measured non-invasively through the skin.
- interventionNames
- Device: RTM
Primary outcomes (1)
- measure
- Sensitivity of the RTM device
- timeFrame
- Results obtained from the RTM device will be compared with those obtained by conventional diagnostic techniques at 6 months.
Secondary outcomes (1)
- measure
- Predictability of the method
- timeFrame
- Results obtained from the RTM device will be compared with those obtained by conventional diagnostic techniques at 6 months.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (11)
- BACKGROUNDGautherie M. Temperature and blood flow patterns in breast cancer during natural evolution and following radiotherapy. Prog Clin Biol Res. 1982;107:21-64. No abstract available. PMID 7167480
- BACKGROUNDGautherie M, Gros CM. Breast thermography and cancer risk prediction. Cancer. 1980 Jan 1;45(1):51-6. doi: 10.1002/1097-0142(19800101)45:13.0.co;2-l. PMID 7351006
- BACKGROUNDYahara T, Koga T, Yoshida S, Nakagawa S, Deguchi H, Shirouzu K. Relationship between microvessel density and thermographic hot areas in breast cancer. Surg Today. 2003;33(4):243-8. doi: 10.1007/s005950300055. PMID 12707816
- BACKGROUNDBarrett AH, Myers PC. Subcutaneous temperatures: a method of noninvasive sensing. Science. 1975 Nov 14;190(4215):669-71. doi: 10.1126/science.1188361. PMID 1188361
- BACKGROUNDTahir H, Shah E, Siores C, Daskalakis. Non-invasive devices for early detection of breast tissue oncological abnormalities using microwave radio thermometry. HalaGali-Muhtasib. Advances in Cancer Therapy. InTech, 2011; 447-476.
- BACKGROUNDToutouzas K, Grassos C, Drakopoulou M, Synetos A, Tsiamis E, Aggeli C, Stathogiannis K, Klettas D, Kavantzas N, Agrogiannis G, Patsouris E, Klonaris C, Liasis N, Tousoulis D, Siores E, Stefanadis C. First in vivo application of microwave radiometry in human carotids: a new noninvasive method for detection of local inflammatory activation. J Am Coll Cardiol. 2012 May 1;59(18):1645-53. doi: 10.1016/j.jacc.2012.01.033. PMID 22538335
- BACKGROUNDToutouzas K, Synetos A, Nikolaou C, Stathogiannis K, Tsiamis E, Stefanadis C. Microwave radiometry: a new non-invasive method for the detection of vulnerable plaque. Cardiovasc Diagn Ther. 2012 Dec;2(4):290-7. doi: 10.3978/j.issn.2223-3652.2012.10.09. PMID 24282729
- Klemetsen O, Birkelund Y, Jacobsen SK, Maccarini PF, Stauffer PR. DESIGN OF MEDICAL RADIOMETER FRONT-END FOR IMPROVED PERFORMANCE. Prog Electromagn Res B Pier B. 2011;27:289-306. doi: 10.2528/pierb10101204.