breast cancer screening device / infrared thermography_leaflet
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MEDICAL INFORMATION Thermography is a functional imaging method approved in 1982 by the U.S. Food and Drug Administration as a method supporting diagnostic imaging of mammary glands in women. On the basis of significantly increased temperature characteristic for pathophysiological changes, the thermography allows for the detection of early pathologies in women’s breasts. The physiological basis for the application of contact thermography as a supportive tool in medical diagnostic imaging is the ‘dermothermal effect’, in which cancer cells show a higher metabolism rate than other cells. Cancer core areas are statistically often accompanied by hyperthermia. Moreover, the measured thermal gradient (against the physiological temperature) is also an important element in differentiating the type of cancerous process*. *Qi Zhao, Jiaming Zhang, Ru Wang, Wei Cong: Use of a thermocouple for malignant tumor detection; IEEE Engineering in Medicine and Biology Magazine 0739-5175/08 January/February (2008) CLINICAL STUDIES Contact thermography as a method supporting diagnostic imaging of mammary glands has been proven efficacious in the following clinical studies: ■ BR/BRA/06/09 – single-centre pilot study with 35 women included. BRA/03/2013 (ThermaCRAC) – ‘Observational study to compare the efficacy of the Braster Tester device in diagnostic procedures and delineation of breast pathologies in women versus standard diagnostic procedures’ – multi-centre observational study with 736 women included. The study revealed that the method’s average sensitivity was 72% while its specificity was 58%*: Soon, we will put in the hands of millions of women all around the world the first innovative device for breast examination at home. for women aged 50 years and older – the sensitivity and specificity was 76% and 59%, respectively; for women aged 50 years and younger – the sensitivity and specificity was 59% and 58%, respectively; for women with fatty breast tissue – the sensitivity and specificity was 100% and 64%, respectively; for women with glandular breast tissue – the sensitivity and specificity was 71% and 63%, respectively. The sensitivity of contact thermography combined with mammography increases to 96% [95% Cl 88-89], improving the diagnostic accuracy in the multimodal procedure. WHAT IS BRASTER? Braster is the future of home breast cancer screening. Making use of state-of-the-art technologies, we have developed a very effective method of breast selfexamination, which will become key to women living a healthy and long life. BRA 03/2014 (ThermaRAK) – multi-center observational study with 318 women included; study purpose: to collect data from the thermographic examination as well as data from imaging and histopathological examinations needed to prepare an atlas of thermal pathologies. BRA/11/2014 (ThermaALG) – ‘Observational study to assess the diagnostic accuracy and clinical utility of the new version of interpretation algorithm applied in the thermographic examination performed with the use of the BRASTER Tester in diagnostic procedures for breast pathologies in women’ – multi-center observational study with 280 women included. BRA/12/2015 (ThermaMED) – ‘Observational study to assess the diagnostic accuracy and clinical utility of the BRASTER Tester device in the diagnostic procedures for breast pathologies in women’ – multi-center observational study; additional study purpose: to verify inclusion and exclusion criteria with regard to additional applications of contact thermography. *The latest, though as yet unpublished, results for indicators of sensitivity and specificity have significantly improved, achieving the following values: 74% for

What are the advantages of regular breast examination with Braster? The examination is performed in comfortable conditions at home – it takes only 10 min. How does Braster work? efficacy when combined with mammography *Clinical study report BRA/03/2013 – ThermaCRAC Patented thermographic matrix detects abnormal changes in breast Breast cancer can affect every woman, regardless of her lifestyle. The disease attacks the body, with cancer cells multiplying more quickly than normal cells. Higher rate of metabolism and a dense network of capillary vessels form areas of increased temperature. The...