ADDRESS THIS LETTER WITH YOUR INFORMATION AND USE AND DISTRIBUTE. PLEASE FEEL FREE TO PERSONALIZE THIS LETTER HOWEVER YOU FEEL IS APPROPRIATE TO YOUR CASE. To Whom It May Concern: As a woman concerned about my breast healthcare, I am asking you, as my insurance carrier to cover the cost of my Digital Infrared Thermal Image that I have had done as an adjunctive breast screening for breast cancer. There are many compelling reasons for a woman to avail herself of this valuable technology, and for my insurance company to cover the cost of this testing. 1. Digital Infrared Thermal Imaging has been FDA approved for adjunctive breast screening since 1982. 2. It is completely risk free exam, with no radiation exposure. 3. There are no potentially harmful contrast agents used. 4. There is no painful and potentially damaging compression. 5. It is extremely cost effective and affordable. 6. It provides functional health information that is not provided by any other screening modality. 7. DITI is safe for pregnant and nursing women. 8. DITI is effective for women under age 50 and those with dense breast tissue. 9. DITI may be used for women for whom other imaging modalities may be inappropriate, for example, women with breast implants. 10. It takes 8-10 years for a tumor to grow large enough to bounce off an Xray mammography. DITI can see these earliest subclinical changes, years ahead of that time, before the disease of breast cancer has the opportunity to ravage a life. Digital Infrared Thermal Imaging is an FDA-approved adjunctive breast screening modality. It is based on the principle that the formation of new blood vessels to feed a growing tumor (neoangiogenesis) along with the dilatation of exisiting blood vessels create heat in the precancerous and surrounding tissues due to the higher level of metabolic activity. This higher level of heat is easily distinguished in what are normally cool, healthy breast tissue. Under strict temperature protocols with technologically advanced high resolution cameras, the body temperature is detected, analyzed, and digitally produced into high resolution diagnostic images of these temperature variations. These abnormal thermal signals may be the earliest indications that a disease process is underway or currently present. Consider this analogy: if someone is having a cardiac workup, that work up with an echocardiogram alone as a structural exam, would be incomplete study. To be a full work up, a person should also have accompanying blood work, lipid panel, C-reactive protein, homocysteine levels, etc. Thermography is the equivalent of this blood work. It gives a more complete, fuller picture. A person may have normal cardiac structure on echo, but have blood work levels that are abnormal, that may pose health risks. Echocardiogram alone would not pick that up. The two modalities are not in competition with each other; they work in conjunction, providing different pieces of the puzzle. So it is with Digital Infrared Thermal Imaging and mammography. Alone, mammography provides an inadequate and incomplete picture of a woman’s breast health. Infrared imaging, based more on process than structural changes, and requiring neither contact, compression, radiation nor venous access, provides pertinent and practical complimentary information to both clinical examination and mammography. Quality controlled abnormal infrared images heighten our index of suspicion in cases where clinical or mammographic findings are equivocal or nonspecific and signal the need for further investigation rather than observation. With the addition of infrared imaging, our sensitivity of image detection has increased from 83% to 93%. John Keyserlingk, M.D., Ph.D. Oncological Surgeon Ville Marie Breast and Oncology Center Department of Oncology Hospital, Montreal, Quebec - St. Mary's According to the New Jersey Cancer Center, the leading cause of death for young women, ages 25 to 30 is: breast cancer. Yet, with all of our evolved western technology, our medical system has not even developed a protocol for screening women in this age group. Breast cancer in pregnant women is the most commonly diagnosed cancer, along with skin cancer. Again, lack of effective protocols delays diagnosis of this terrible disease. Thermography is a tool that we can be using to help identify these young women most at risk for breast cancer at younger age. Most young women start screening for cervical cancer at age 18. In the same way, if we started screening women with thermography, we would be able to see these early risk factors for breast cancer, and follow these women more closely. The terrible diagnosis of breast cancer could potentially even be avoided by some, or caught at the earliest possible time. This younger age group of women typically develop more aggressive breast cancers. It takes 8-10 years for a tumor the size of a dime to grow; so if women are dying, or even just diagnosed at age 25, their cancer started growing at age 15-17 years old. That is a rather sobering thought for most of us. However, it remains that there is a long subclinical window of opportunity to catch this disease process in the earliest stages. We have the window; we just have to make the most of it. Thermography may be the least invasive, risk-free assessment tool that we have. Perhaps this early warning would have made a difference for Susan G. Komen, and the many other women who have lost their lives to breast cancer. I again ask you to cover the cost of this simple, effective breast screening exam. The following are excerpts and abstracts of journal articles and studies on Digital Infrared Thermal Imaging. Sincerely, Your Insurance Subscriber “American Journal of Radiology” Received January 8, 2002, accepted after revision, July 10, 2002. Abstract: OBJECTIVE. The purpose of this clinical trial was to determine the efficacy of a dynamic computerized infrared imaging system for distinguishing between benign and malignant lesions in patients undergoing biopsy on the basis of mammographic findings. SUBJECTS AND METHODS. A 4-year clinical trial was conducted at five institutions using infrared imaging of patients for whom breast biopsy had been recommended. The data from a blinded subject set were obtained in 769 subjects with 875 biopsied lesions resulting in 187 malignant and 688 benign findings. The infrared technique records a series of sequential images that provides an assessment of the infrared information in a mammographically identified area. The suspicious area is localized on the infrared image by the radiologist using mammograms, and an index of suspicion is determined, yielding a negative or positive result. RESULTS. In the 875 biopsied lesions, the index of suspicion resulted in a 97% sensitivity, a 14% specificity, a 95% negative predictive value, and a 24% positive predictive value. Lesions that were assessed as false-negative by infrared analysis were microcalcifications, so an additional analysis was performed in a subset excluding lesions described only as microcalcification. In this restricted subset of 448 subjects with 479 lesions and 110 malignancies, the index of suspicion resulted in a 99% sensitivity, an 18% specificity, a 99% negative predictive value, and a 27% positive predictive value. Analysis of infrared imaging performance in all 875 biopsied lesions revealed that specificity was statistically improved in dense breast tissue compared with fatty breast tissue. CONCLUSION. Infrared imaging offers a safe noninvasive procedure that would be valuable as an adjunct to mammography in determining whether a lesion is benign or malignant. “Journal of IEEE Engineering” May/June 2000 pp 30-41. Summary: Functional Infrared Imaging of the Breast Digital mammography is being developed to further advance the contribution of structural imaging such as mammography and ultrasound. However, there is now new emphasis on developing functional imaging that can exploit early vascular and metabolic changes associated with tumor initiation that often predate morphological changes that most of our current structural imaging modalities still depend on; thus, the enthusiasm in the development of sestamibi scanning, Doppler ultrasound, and MRI of the breast [ 16]. Unfortunately, as promising as these modalities are, they are often too cumbersome, costly, inaccessible, or require intravenous access to be used as first-line detection modalities alongside clinical exam and mammography. On the other hand, integrating IR imaging, a safe and practical modality, into the first-line strategy, can increase the sensitivity at this crucial stage by providing an early warning of an abnormality that in some cases is not evident in the other components (Fig. 5). Combining IR imaging and mammography in an IR-assisted mammography strategy is particularly appealing in the current era of increased emphasis on screening by imaging and less reliance on palpation as tumor size further decreases. “Surgery Today” 2003. 33:243-248.) summary: Relationship Between Microvessel Density and Thermographic Hot Areas in Breast Cancer In the clinical management of breast cancer, thermography may play two potential roles. First, it may be utilized as a method of screening for breast lesions, either malignant or benign; and second, it may be able to differentiate malignant from benign lesions that have been detected by other methods.1,2,7 The advantage of thermography lies in the fact that it is noninvasive and does not require irradiation. As a measure for detecting tumors of the breast, it has a false-negative rate of nearly 10%, which is similar to that of mammography or ultrasound.