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The process can be simply defined as a non-invasive dynamic temperature analysis of the breast, enhanced with the bioinformatics software that integrates a number of over-laying mathematical and medical disciplines and computer-aided functions including the use of temperature analysis, chronology, and algorithmic and statistical analysis. Never before has a system of such accuracy been developed or implemented.
The basis for our proof of concept is Chronomics-- the scientific study of the effect of time on living systems and of biological rhythms. Angiogenic activity, new blood vessel growth, creates a measurable temperature change. The first chart shows temperature results for fibro adenoma and the second below is a breast cancer tissue showing the temperatures changes over time as well as different measurements for each type of tissue. As tissues transition from normal to hyperplasia, to atypical hyperplasia, to cancer in-situ to, to invasive cancer they develop their own distinct thermal finger print and can be compared with normal tissue temperature, to show:
Theoretically, a cancer must grow through thirty (30) tumor volume doubling times (TVDT) before reaching a clinically palpable size, 1cm (small pea size). Evidence now indicates, however that tumor growth is dependent on circadian rhythm timing and angiogenesis (new vessel growth). After a tumor attains a microscopic size of a few micro-millimeters in diameter (106), further growth of the cell population requires new capillary blood vessels. Most of the new vessel growth around malignancies have no smooth muscle and are, therefore, not enervated, rendering them unresponsive to the control of epinephrine. It has been shown that this lack of vessel receptivity produces a more constant blood flow and a tumor temperature with less circadian variation than that of the surrounding healthy host tissue. These new, proliferating capillaries have fragmented basement membranes and are leaky, making these new vessels more penetrable by tumor cells than are mature vessels. This new vascular phase of growth is usually followed by rapid tumor growth, bleeding, and metastasis. Recent research revealed the median TVDT for an invasive breast cancer is approximately 130 days – Thus, this model is based on 130 tumor volume doubling times, taken from Estimated Breast Cancer Growth Rates from Screening Database Information 2003, Journal of Women’s Imaging Vol5, Number 1, 11-19
The goal the First Warning Breast System™ is to enhance clinical breast examination aiding in the reduction of superfluous mammograms, needless biopsies, and other screening/diagnostic procedures, as well as to develop a physiological profile of the changing breast over time, to identify breast tissue abnormalities at their earliest stages. The unique value of the First Warning System™ is related to detecting tissue growth pattern changes at any stage of development, regardless of the type of breast lesion. Each tissue type has its own distinct thermal fingerprint, including dense breast tissue. If a primary care physician gets a positive test with the First Warning System™ and thinks the breast is abnormal and the patient can be referred for further diagnosis. These results can also used by the radiologist to provide physiological evidence that there is an abnormality in the breast. Computer Assisted Diagnosis (CAD) is widely used today, but it is based on a data from other mammographic results and does not take advantage of physiological data which is far more accurate.