Infrared mammography
The two Yannacone patents on infrared imaging for early detection of angiogenic processes, the integral method patent for rapid screening and the differential method patent for localization of angiogenic processes, describe a unique method utilizing high resolution dynamic digital infrared imaging technology, sophisticated image processing, state-of-the-art signal processing, and proprietary analytical software for observing and monitoring physiological activity. While there are a number of patents that deal with medical applications of infrared imaging, none of them “teach” a commercially viable system for early detection of statistically significant physiological anomalous processes within human tissues and organs, much less a physiologically based method for early detection of breast cancer.
The infrared image processing systems described in the patents provide substantially more clinical information about the angiogenic processes which are at the heart of neoplastic (cancerous) activity in human tissue and organs — physiologic processes — than the anatomical images provided by traditional X-ray mammography or even MRI.
The two Yannacone patents clearly teach two independent but complementary methods for early detection of statistically significant physiological anomalies, the “integral” method which is suitable for rapid near real-time screening and the “differential” method which is suitable for precise location and monitoring of particular “areas of interest”.
Processing the signals from multiple images taken over a period of thermal challenge and then analyzing the data using well-established, statistical techniques eliminates the need for any “interpretation” of the infrared images and permits comparison of comparable areas and vascular regions in each breast simultaneously for each image set at each examination. The ability to “register” the image sets from each successive examination based on the spatial relationships that excxist among the bifurcations of the blood vessel withinin the mass of breast tissue permits the physician to monitor breast health precisely by recording changes in physiological activity over time and quantifying those changes in even the smallest irregularities over time with multiple non-invasive examinations.
A Brief History of Medical Infrared Imaging
The uses of infrared imaging in medicine are clouded as a result of the failures of liquid crystal thermography and early attempts at electronic thermography with primitive infrared imaging devices. The necessary technological advances, high resolution digital infrared imaging systems, and the appropriate digital signal processing and interpretive software did not become commercially available until the mid 1990s.
The concept of imaging heat patterns radiating from the human breast as neoplastic disease processess (cancer) develops has been under investigation throughout the world since the 1960s and was the subject of a large scale federal study until 1988 when it was eliminated from consideration by the federal agencies because the strict test requirements for acclimation, environmental consistency and concern over motion driven artifacts led to a belief that it would be statistically too difficult to quantify the benefits and effectiveness of breast thermography. Nevertheless, early clinical evaluation reported sufficient success with even static low resolution infrared imaging that infrared imaging was included in the national Breast Cancer Demonstration and Detection Project (BCDDP) in 1973.
Unfortunately, when alluded to in contemporary literature, evaluations of infrared imaging for early detection of breast cancer are still based on information from ddecades-old technology using liquid crystal measurements of skin surface temperature and qualitative interpretation by examiners with limited training.
A diagnostic center in Canada using an early digital infrared imaging system without the breast cancer specific application algorithms, reported to the American Society of Clinical Oncology meeting in Denver on 20 May 1997, that Infrared Mammography “constituted a safe, practical and informative adjuvant primary imaging modality, particularly in those with either intermediate or negative physical examination or [X-ray] mammography. In many of these patients, it constituted the most obvious indication of the malignant process.” The limited system used in that study located a number of tumors that X-ray mammography missed in women under the age of 50.
The Infrared Mammography Method
Using the Infrared Mammography System, the patient disrobes from the waist up and is seated in a comfortable chair with her arms supported in an elevated position on custom designed adjustable arm rests which enable the infrared imager to “see” the sides of the breasts and the auxiliary region under the arms. Room temperature air from four small fans blows toward the patient’s chest as the infrared camera records the infrared energy emitted from the skin and transmits the raw data to the local on-site computer for pre-processing.
As the skin surface of the breasts cools in response to the gently moving air, the sympathetic nervous system reduces the blood flow to all the breast tissue in an orderly fashion over time in order to preserve core body temperature. The infrared camera detects and the computer records and analyzes these changes in infrared emissions from the skin over time.
The actual infrared examination takes less than five minutes regardless of how the images are eventually processed. The “Integral” method is a quick screening technique and the report is available tothe doctor and patient in less than 15 minutes. If the results are “suspicious”, a follow up analysis of the data using the “differential” method can locate the statistically significant anomalous physiological activity in the volume of breast tissue and characterize the nature of the activity in less than an hour.
The infrared imaging device receives electromagnetic energy in the infrared region much as a radio or television receiver does in the radio frequency region. Infrared energy emitted from the skin surface behaves like radio waves emanating from a ground plane antenna and not like the heat from a household radiator which flows from the floor up to the ceiling and then fills the room.
Each cell of the skin covering the volume of breast tissue below can be thought of as a tiny radio transmitter sending its own unique signal. Like the problems faced by today’s radio astronomers, detecting, separating and analyzing these small signals requires excellent detectors and intelligent signal processing software in order to distinguish the data from the background noise.
The image processing algorithms used by the Infrared Mammography System for early detection of breast cancer are similar to the algorithms and mathematical techniques used in other high tech industries. In addition to the work being done in astronomy, geophysicists have made remarkable advances in image processing in its efforts to find oil and gas deposits hidden tens of thousands of feet deep within the earth. Like high-resolution dynamic digital infrared imaging, the geophysicists are looking for anomalies in the data stream; trying to find pockets of oil and gas, just as we are trying to find tiny pockets of cancerous tissue. While their goals are different, the imaging and data analysis techniques are remarkably similar and have proved extremely successful.
The Yannacone patents disclose a method for joining together many existing technologies in order to identify tissue beneath the skin which has the suspicious characteristics of supply and nourishment from an unregulated or angiogenic blood supply.
The Infrared Mammography™ System:
• Does not expose the patient to X-rays or any other form of ionizing radiation.
• There is no physical contact with the breast tissue during Infrared Mammography.
• Infrared Mammography does not require the significant and often painful flattening of the breast tissue necessary for X-ray mammography.
• There are no strong magnetic fields associated with Infrared Mammography.
• Infrared Mammography is less expensive than X-ray mammography and offers much better detection rates and extremely low false positives.
• Women of any age—even if pregnant or lactating—can obtain an Infrared Mammography study.
• Infrared Mammography is not affected by the density of the breast tissue, as is the case with X-ray mammography, and is especially suitable for women under 40 years of age.
• Results of the Infrared Mammography study are available for the patient and her physician to view and discuss within them time of a single office visit.
• Infrared Mammography studies are acquired, processed and stored in a digital format for ease of reproduction and transmission.
• The Infrared Mammography System could radically change breast cancer screening and should significantly reduce mortality rates through early detection of neoplastic processes in the breast.
Women at risk: unmet Needs
It is well established that early detection is the most effective means of reducing the significant annual death rate from breast cancer and the pain and disfigurement that the survivors experience.
The enormous financial cost to society as a result of breast cancer can be attributed to the lack of a reliable, inexpensive, non-invasive means of rapidly screening large numbers of women for early detection of the neoplastic processes that eventually may become a palpable tumor and often fatal breast cancer.
X-ray mammography has been the established method of screening for breast cancer for many years but suffers from serious limitations. All too often it is reported that “we could have saved the breast” or “we could have saved the patient” if only the cancer had been detected earlier.
There is still currently no economical, practical and convenient physiological screening method for early detection of breast cancer that is both sensitive and reliable in detecting neoplastic activity and selective in minimizing false positive results.
With 55,000 deaths a year attributed to breast cancer, Infrared Mammography offers an inexpensive, pain-free and rapid mass screening system.
Infrared Mammography is particularly appropriate for the more than 20 million high-risk patients under age 40 for whom X-ray mammography is not recommended until there are other physical signs of breast cancer—at which time it is often too late!
X-ray mammography is least effective in this age group as their breast tissue is much more dense than that of older women. This is the group with the highest death rate among breast cancer victims and the group in which the cancers which do occur are most aggressive and rapidly growing.
Infrared Mammography™ differs from other Technologies
At present, there are only a small number of technologies used in the early detection of breast cancer: X-ray mammography, manual examination feeling for lumps, ultrasound and MRI. Each of these methods are anatomical in that they are looking for structures such as lumps or micro calcifications within the breast. It is only with a biopsy that the nature of these structures can be determined. It is difficult for X-rays and MRI imaging to distinguish between living and dead tissue.
Infrared Mammography evaluates physiological activity in living tissue and looks for the unique physiological activity associated with the angiogenic blood supply which may be nourishing neoplastic lesions. Benign lesions such as cysts in breast tissue will not exhibit the unique characteristics of neoplastic lesions and many of the false positive results of ultrasound examinations can be avoided.