The images and text in this guide may not be reproduced in part or whole in ANY format,
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Therma-Scan Reference Laboratory, LLC.
34100 Woodward Ave. Suite 100 Birmingham, MI 48009 USA.
Thermology is the medical science that derives diagnostic indications from highly detailed and sensitive infrared images of the human body by applying a quantitative and objective analytic system. Thermology is sometimes referred to as digital infrared imaging, diagnostic infrared imaging, infrared mammography or tele-thermology and involves the use of highly resolute and sensitive infrared (thermographic) cameras. Thermology is a patho-physiologic imaging discipline, completely non-contact and involves no form of energy imparted onto or into the body. Thermology has established applications in breast oncology, vascular medicine, chiropractic, dentistry, neurology, occupational medicine, orthopedics, pain management and veterinary medicine.
The aura of modern thermology's cutting-edge technology obscures its venerated origins as one of Hippocrates' cardinal signs of pathology: Calor (heat). 400 BCE in The Book of Prognostics, Hippocrates of Cos wrote; "In whatever part of the body excess of heat or cold is felt, the disease is there to be discovered" (1). The ancient Greek physicians of the Golden Age were known to employ a primitive form of thermal imaging as they would apply thin mud slurry onto areas of their patient's bodies to observe the patterns and rates of drying. Modern thermology has been refined into a proper, albeit young science with a vast and rich history. The first electronic infrared sensors were developed in the 1950's for military intelligence and then were provided for medicine (2). The early thermologists of the modern era were accomplished and comprehensive experts in their respective fields of breast oncology, vascular medicine or neurology. These pioneering thermologists worked in specialty centers with a multi-modality approach to diagnostic medicine. They discovered that the thermograms of women with breast cancer characteristically presented aberrant high-energy blood vessels overlying the tumor (3). However, it was not until more recent times that it was established the hot patterns of breast cancer were the result of dis-regulated hyperemia of core body-temperature blood flowing to a relatively superficial area in the female breast (4, 5, 6, 7, 8, 9).
Are you a licensed health-care professional able to refer patients for complementary studies (ultrasound, mammography, MRI) indicated by atypical or abnormal breast thermology studies? You could add diagnostic thermology to your practice. Therma-Scan Reference Laboratory would like to work with you and we invite you to contact our office at 248-593-8700.
The first generation of electronic infrared cameras were bulky electro-mechanical-optical devices with revolving prisms and tilting mirrors run by synchronized electric motors that scanned a two dimensional image across a single-element detector one point at a time. The first models required twenty minutes to completely scan a single image. These were analog instruments and the images they produced were non-quantitative. However, they heralded a totally new means of imaging what had previously been invisible; thermal energy and with it a new world of information. Unlike visible light, infrared energy is evaluated directly from a source rather than by reflection. There are no colors inherent to infrared, just energy levels that can be quantified in meaningful units, quantum or degrees Celsius. The very large costs involved in developing this technology were borne by military intelligence and applied to surveillance from orbiting satellites. The first non-military application of this technology was for medicine and the first medical application was to evaluate breast cancer (1). While infrared imaging has been slow to integrate into common application in Medicine, infrared imaging has widely applied into many scientific, engineering and industrial applications. These demanding technical applications of infrared imaging have spurred the development of solid-state cameras with focal plane array detectors; essentially tens of thousands of individual infrared detectors on a chip. These cameras have provided great improvements in equipment reliability, frame rate and spatial resolution. As detector technology has improved, it is possible to place more of these detector elements into the focal plane array for higher spatial resolution and improve the sensitivity of those detector elements for higher thermal resolution (2). There are a variety of infrared cameras available to meet the many applications that range from industrial preventive maintenance to medical diagnostic imaging and research.
Infrared imaging systems intended for medical application are regulated by the US Food and Drug Administration under Title 21, Parts 800-898 of the Code of Federal Regulations. The ‘510(k)’ provision of this regulation only requires the infrared imaging system be “substantially equivalent to devices legally marketed in interstate commerce prior to the May 28, 1976 enactment of the Medical Devices Amendment to the Federal Food, Drug and Cosmetic Act.” The rate of technological developments of infrared imaging systems since that time has been at least as great as the developments of the personal computer. Consider how much more powerful is the contemporary personal computer than was available in 1976 and you can appreciate the relatively low technologic standards by which infrared imaging systems can be legally sold as a class one medical devices.
The infrared imaging systems that are used in medical applications today fall into two categories: thermal imagers and radiometric infrared cameras.
Thermal imagers typically produce a non-calibrated analog or non-quantified digital output signal based upon the level of infrared energy emitted by the body. In order to obtain a temperature measurement of any point within the image, the signal output of the thermal imager must be associated to a calibrated temperature reference (blackbody). This temperature reference is, usually, external hardware that enables an offset adjustment to the imaging software running on a computer. The imaging software must be scaled to a calibration equation that interpolates the temperature values along a mathematical curve that is fit between the levels of the calibrated temperature reference sources. This interpolation process must be done continuously since thermal imagers have no built-in thermal drift compensation which causes the temperature calibration scale level to “float” over changing conditions in and around the thermal imager (2). Thermal imagers are speculative tools for any type of quantitative application that will become increasingly unreliable between calibrations due to thermal drift of their detectors but are marketed for medical application as they are significantly less costly.
Radiometric infrared cameras operate in a manner that is markedly different from infrared imagers. Radiometric infrared cameras perform the quantitative thermal measurements of a patient's emitted infrared energy within the firmware of the camera by continuously calculating digital temperature measurements through a large thermal span and not just scaled to two externally calibrated temperature standards. The radiometric infrared cameras also provide for thermal drift compensation that guarantees the temperature measurements are stable and accurate at all points within the camera operating temperature range (i.e. the values do not “float” as with non-calibrated thermal imaging cameras). Radiometric infrared cameras should be considered quantitative instruments as they produce digital temperature measurements internally and output this data to the computer rather than requiring the computer’s software to perform an interpolation of the temperature values (2).
The inherent inefficiencies of metabolism are the source of body heat. This heat must be transferred to the environment or its accumulation will increase body temperature, cause the destructive denaturizing of body proteins and ultimately death (1). At comfortable room temperatures, the principle means of body heat loss to the environment is emission of infrared energy from the skin. Human skin, irrespective of its pigmentation, is an almost perfectly efficient emitter of infrared energy; meaning that the intensity of infrared energy occurs in direct proportion to skin temperature (2). The emission of infrared energy from the skin is quite superficial and skin temperature is principally affected by small-caliber vascular perfusion (3). Skin perfusion is, in turn, modulated by the autonomic nervous system as a means of maintaining the close regulation of core body temperature (4). It is the regulation of core body heat that, largely, affects skin temperature. Thermal energy from deeper tissues will "float" to the skin surface and present an infrared "character" that is distinctive for each anatomic site (5).
The new blood vessel development (neo-angiogenesis) of a solid cancerous tumor must occur when it has grown too large for simple diffusion from existing blood vessels to provide for the metabolic needs of the cells at the center of the tumor. The process of neo-angiogenesis begins before a cancerous tumor is about 150 micrometers (0.15mm) in diameter and must be extensively developed by the time a tumor is 1-2 mm in diameter (6). The neo-angiogenic blood vessels distinctive of cancer are unstable and do not have the ordered structure of normal blood vessels. In fact, neo-angiogenic vessels are of a primitive sinusoid structure without any connection to the autonomic nervous system and without effective vascular smooth muscle (7).
Nitric oxide is a readily diffusible gas produced in very high concentrations as a consequence of an inducible enzyme produced as part of an abnormal metabolic pathway inherent to metaplastic and malignant tissue with the effect of potent regional vasodilatation (8, 9). Thermology is able to characterize breast cancer by indicating the unregulated hyperemia of these defective blood vessels and resulting convection of body core thermal energy to the relatively superficial region of the disease. This means the defective blood vessels of breast cancer can be indicated during an intentional challenge procedure to the autonomic nervous system by their inability to constrict, as contrasted from normal blood vessels that will constrict and cool the overlying skin (10). In fact, our experience demonstrates that breast cancer-related blood vessels may actually increase their flow and skin temperature subsequent to the autonomic challenge procedure, probably from shunting.
High-sensitivity digital radiometric focal plane infrared cameras are coupled with powerful computers and sophisticated software to enable a quantum step as a diagnostic technique in functional medicine. Thermology interpretative standards necessarily involve a quantitative analysis of the data. Thermology has established diagnostic effectiveness in rheumatology, neurology, physiotherapy, sports medicine, orthopedics, pediatrics as well as oncology. Furthermore, the high sensitivity of thermology often makes an invaluable monitor of the effectiveness of some patient treatment programs.
The practical application of this challenge procedure involves placing a woman's hands into a basin of cold (approximately 11 degrees C) water for one minute between two sets of identically positioned images. The cold water acts as an intentional challenge to the autonomic nervous system. The expected response to this challenge is a vaso-constrictive effect that will provide a uniform and bilaterally symmetrical cooling effect to the skin. The pre- and post-challenge images can be compared in order to evaluate a decrease in skin temperature as a result of an adaptive physiologic constriction in the caliber of normal blood vessels. This technique, then, contrasts the normal and reactive blood vessels from the non-responding blood vessels that are an important means of identifying neo-angiogenic and nitric oxide-dilated blood vessels characteristic of cancer. Other techniques that blow cold air or spray cold water or alcohol onto a woman's breasts produce significant and complicated artifact rather than a single variable physiologic challenge; we consider these techniques as unsound. It is our experience that the autonomic challenge greatly improves the specificity of breast thermology, diminishing the number of false-positive errors by differentiating non-cancerous inflammation or mastitis as a basis for atypical high-energy blood vessels (1). The autonomic challenge procedure also diminishes the number of false-negative errors by contrasting non-modulating blood vessels from other prominent blood vessels in the same or contralateral breast.
The incidence of breast cancer has rapidly increased in the past fifty years. What was once a disease largely limited to women over sixty years of age and with a life-time incidence of one-in-twenty, has increased its incidence to a life-time rate of one-in-eight with a disproportionate increase in younger women (1). While rare, we have confirmed cases of breast cancer in pre-teens and breast cancer is now the leading cause of death for women aged 29-45 (1). Recent published studies have demonstrated a rather low benefit to routine screening with X-ray mammography and many serious adverse complications (2, 3). The 2009 US Preventive Services Task Force could not determine any meaningful benefit to routine screening X-ray mammography for women less than fifty years of age or for screening X-ray mammography more than every other year for women between ages fifty and seventy-four (4). Every woman is at risk for breast cancer and the inadequacies of screening X-ray mammography to save lives should not diminish the importance to screen women younger than fifty years or between biennial X-ray mammograms. While screening X-ray mammography remains the standard of care, we assert that it is insufficient as a stand-alone modality due to its insensitivity for large populations of at-risk women and a very high rate of false-positive results.
The high sensitivity of thermology for younger women and its absolute safety are compelling reasons to indicate routine screening thermology for women under fifty years of age and in the year between routine screening X-ray mammograms for women between fifty and seventy-four years of age (5).
There are well over eight hundred peer-reviewed clinical studies on diagnostic infrared imaging for breast cancer in the Index Medicus with a data-base in excess of 300,000 women participating in these studies, often in large cohorts and some followed for up to twelve years. In 1972, Acting Secretary Thomas Tierney of the US Dept of Health, Education and Welfare released an official position paper that stated “The medical consultants indicate that thermography, in its present state of development, is beyond the experimental stage as a diagnostic procedure in the following 4 areas: (1) Pathology of the female breast. (2)”. On January 29, 1982, the US Food and Drug Administration published its formal listing and classification of thermography as an adjunctive diagnostic device for breast cancer. In 2005 the FDA reaffirmed this position and classification (1). The US National Cancer Institute states “The use of thermography, also known as digital infrared imaging, is based on the principle that chemical and blood vessel activity in both precancerous and the area surrounding a developing breast cancer is almost always higher than in normal tissue. This activity frequently results in an increase in the regional surface temperature of the breast. Thermography uses ultra-sensitive infrared cameras and sophisticated computers to detect, analyze and produce high-resolution of these temperature variations, which may be among the earliest signs of breast cancer.” (2). There are ICD-9, ICD-10 and CPT procedure codes for breast thermology.
THERMOLOGY: STANDARDIZED ANALYSIS & APPLICATION
By the early 1960’s, diagnostic infrared imaging had demonstrated effectiveness for breast cancer in the hands of a few specialized investigators. By 1974, the very favorable results from some small trials prompted the inclusion of thermography into a large-scale study funded by the National Cancer Institute: the Breast Cancer Detection and Demonstration Project (1). Unfortunately, this study was seriously flawed by the lack of specifics and standardization of equipment, technique, analytic criteria and reporting. The resulting failure of this study was widely misinterpreted as a failure of breast thermography - an impression that was often promulgated by other imaging specialists with competitive and proprietary disinterests. Thermography languished in the United States for more than twenty (20) years but was effectively developed in Europe and East Asia with large-scale studies. In 1976, the results of studies at the prestigious Pasteur University in Marseille, France, established an objective analytic system (2, 3). This system has been refined by enhanced knowledge of basic science and the outcome-based clinical studies but remains the basis for reporting breast thermology to this day.
Termed the Marseille system, this analytic method provides for a standardized TH-1 – TH-5 scale as a summary based upon specific, objective and quantitative thermal features and differential levels of infrared energy. Thermal features are divided into Signs and Criteria based upon their established characterization of breast disease (2, 3).
At this time, there are no comprehensive national standards for medical thermology and the medical consumer will have a no real ability to evaluate the relative abilities, claims and quality from a broad range of providers. Some providers have invented novel “professional boards” to give the illusion of a meaningful accreditation to pretentious thermologists without any training or experience prior to a weekend course. You should screen the providers of medical thermology by American Academy of Thermology accreditation and certification by the American Board of Thermology.
While there is a wide recognition that diagnostic infrared imaging is a physiologic process, there is not an equally wide understanding of the underlying physiologic principles. Over fifty years ago, Lawson developed an empirical relationship linking unusually hot skin patterns with underlying cancer in the female breast and with that link founded the modern era of medical thermography (1). The basis for the elevated skin temperatures and breast cancer were the subject of considerable speculation and, as often occurs, the observations preceded the understanding. Interested individuals as well as serious investigators have speculated the heat of focal inflammation, an immune response or the inefficiencies of cancer’s metabolism as the basis for the hot patterns proximal to breast cancer (2, 3). A simple calculation of the energy requirements to maintain the increased temperatures commonly encountered with breast cancer effectively eliminated locally-generated metabolic heat as a possible mechanism for the hot patterns related to breast cancer (4).
Folkman formalized a theory of neo-angiogenesis (the development of new blood vessels) as a requirement for any malignant tumor to grow larger than 0.15mm in diameter (5). Konerding and Steinberg published a study of the ultra-structure of cancer’s neo-angiogenic blood vessels that described their structural and functional abnormalities as to exclude any effective modulation by the autonomic nervous system (6). In the past twenty years, medical scientists have discovered the very high concentrations of Nitric Oxide (a readily diffusible gas) produced by pre-cancerous and cancerous cells. Among its properties is a profound dilatory effect on regional blood vessels. These two abnormal mechanisms, structurally defective neo-angiogenic blood vessels and the strong dilatory effect of Nitric Oxide are almost certainly the basis for the high thermal energy patterns associated with cancer in the female breast as the dis-regulated hyperemia of core body-temperature blood flows to a relatively superficial area in the female breast (7, 8, 9).
The adult female breast will present a variety of high thermal energy patterns based upon many vascular and metabolic conditions unrelated to cancer or any other pathology, such as typically occurs in the later third of the menstrual cycle, during pregnancy or lactation. On prima facie, these non-cancerous high thermal energy patterns can emulate the “hot spots” empirically associated with breast cancer with the important exception of the specific patho-physiologic dis-regulated hyperemia of core body-temperature blood associated with cancer. A simple (as in single variant) functional challenge is necessary to distinguish the hot patterns of breast cancer from the hot patterns of non-cancerous conditions with good reliability (10). The acclimation of a patient in a very cold room (17°C) will dissipate latent heat of the skin but not effectively distinguish the hot patterns associated with breast cancer by temperature levels alone. The complex three-dimensional structure of the female chest prevents a uniform application of sprayed alcohol, cold water or a draft of cold air used to cool the skin and creates a complex thermal artifact rather than a simple physiologic challenge to distinguish the characteristic dis-regulated blood flow of cancer.
While the use of vaso-active drugs or the administration of pure oxygen have the potential to provide a single variant physiologic challenge capable of distinguishing the dis-regulated blood flow in the female breast associated with cancer; cooling a patient’s hands by immersing them wrist-deep into a temperature-defined water bath for a specified time-span provides that consistent and simple physiologic challenge, provided the analytic parameters are derived from a substantive database. Therma-Scan developed that database from trials involving the detailed quantitative analysis of thousands of patient studies and different temperatures of the water bath and time-spans. A large-scale clinical outcome study was presented at the 2004 Congress of the American Academy of Thermology that documented the significant contribution of the cold-challenge technique for substantially increasing the diagnostic specificity of breast thermology (10). A review of the cold-challenge protocols utilized by some thermographers reveals a significant variance in technique with poor application of physiologic principles, such as allowing five to ten minutes to elapse between the cold challenge and subsequent imaging and no specified temperature of the water bath (11).
As a functional study breast thermology complements rather than competes or replaces structural-based imaging methods, such as X-ray mammography, ultrasound and MRI. Exactly as does every other objective diagnostic imaging modality, a positive breast thermology study provides indications of risk for breast cancer and a specific indication for comprehensive evaluation but not a definitive diagnosis. In the truest sense, a diagnosis of breast cancer is not possible until a pathologist performs a histological evaluation from a biopsy. Experience indicates targeted ultrasound as the single most effective means of following-up an abnormal thermology study.
Breast thermology has a very high sensitivity (approximately 97%) but is less specific, as inflammation or infection may cause false-positive findings, especially on initial studies of an individual (1, 2). Women may also have vascular malformations in their breasts’ thermal character as a consequence of mastitis or personal variant that may cause false-positive thermology. However, the stability of atypical thermology features in repeated studies over time is usually sufficient to attribute them to personal variant and distinguish them from breast cancer. False-negative errors are rare and usually a consequence of a latent or lag stage in the development of a breast cancer.
Breast thermology is most effective on a population of women for whom X-ray mammography is rather insensitive. This includes pre-menopausal, pregnant or lactating women as well as women with fibro-cystic disease, dense tissue, prosthetic augmentation, surgical reduction, previous biopsies and unusually small or large breasts. This also includes post-menopausal women taking hormone replacement therapy. Clinical studies have demonstrated a strong correlation between the highest thermology markers and an aggressive character of the cancerous tumor (3, 4). Thermology can also select the best sentinel lymph node in the determination of metastasis. Thermology has real value in monitoring post-surgical patients following a baseline study. Thermology has demonstrated application in evaluating the need for and the effectiveness of anti-angiogenic therapies. Breast thermology regularly provides specific indications of breast cancer years before specific features are detected by mammography (5, 6, 7, 8).
The first classification category in the Marseille system defines a normal thermal profile of the breasts that is devoid of any of the thermology signs or criteria associated with risk for breast cancer. All thermal features demonstrate normal and adaptive response to the autonomic challenge. Normal contours are discerned and no significantly hyperthermic focal or vascular features are presented. Some patients will demonstrate distinct and significantly hypothermic patterns that are frequently associated with established cysts and/or fibro-adenomas. This will modify the classification as a TH-1F. Annual comparative restudy is recommended.
The second classification in the Marseille system defines a thermal profile of the breasts that features symmetrical, non-complex and moderately hyperthermic vascular patterns. All thermal features demonstrate normal and adaptive response to the autonomic challenge. The TH-2 classification indicates no thermology signs or criteria associated with breast cancer. However, while very unlikely, it is possible that some small cancerous tumors may be in a quiescent state and their vascular development could be minimal. In this event, the very minor thermal characteristics may evade discernment, especially in an initial study. The high-energy vascular patterns of the TH-2 classification are associated with benign glandular hypertrophy as may be caused by elevated blood levels of estrogens or disproportionate blood levels of estrogens to progesterones. The TH-2 classification is common during pregnancy and lactation. This thermology category is also associated with the development of cysts and fibro-adenomas. This will modify the classification as TH-2F. Annual comparative thermology restudy is recommended and more frequent restudy may be clinically indicated.
The third classification of the Marseille system defines a single thermology sign and indicates an atypical metabolic or vascular process associated with a minor or equivocal (<10% to 20% as specified in the individual report) risk for confirming breast cancer. This may be based upon the discernment of an asymmetric and hyperthermic vascular or focal pattern, an asymmetric, diffuse and hyperthermic pattern involving a peri-areolar area or most of one breast, a discrete area in a vascular pattern that does not attenuate from the challenge procedure or an asymmetric physical distortion with local hyperthermia. It is likely that these atypical thermal features represent benign changes such as inflammation, acute cysts and/or fibroadenoma development, infection or personal variant. A thermology restudy in 120-180 days usually provides a differentiation. Clinical correlation is indicated for an association with a mass or abnormal skin changes that would have an additive effect on the overall risk for breast cancer. Strong familial or personal factors for breast cancer are also of additive risk. Other objective means of evaluating the breasts may be indicated. Experience demonstrates a targeted ultrasound as the single most effective means of following-up on atypical or abnormal breast thermology. Blood markers such as CA 15.3, CA 27.29, TRU-QUANT, creatin-kinase-BB and even elevated ferritin may be useful and X-ray mammography may be indicated in the context of a women’s overall risk profile.
The post-surgical woman receives a special modifier "M", designating Mastectomy or "L", designating Lumpectomy. These are frequently used with the third category of the Marseille system on an initial study when any atypical thermal features are evident. The surgical procedures and radiation/chemotherapy treatments typically produce significant tissue inflammation, edema, abnormal tissue metabolism, nerve damage and revascularization that will likely impede the normal regulation of blood flow in the breast and results in artifact of the thermal patterns. These forms of artifact limit the value of thermology for approximately three months post-procedural when their influence usually has abated. Radiation treatment to the breast or mastectomy site may results in a lasting vaso-regulatory disorder that typically causes a diffuse and significantly hyperthermic artifact. Our experience indicates thermology has been a useful means of monitoring the post-surgical woman for indications of persistent or recurrent breast cancer, especially in the axillary or sternal regions. The initial study may be of limited value and its best value obtained as a baseline for comparative restudy in 90-120 days.
The fourth classification in the Marseille system defines two or more thermology signs or a single thermology criterion. This must be considered a positive result and represents a significant (65-85% as specified in the individual report) risk for breast cancer. Benign processes and personal variant are possible but unlikely as a basis for this abnormal classification, especially on an initial study. A clinical correlation is indicated for regional masses or abnormal skin changes and other means of objective evaluation (targeted ultrasound, X-ray mammography, MRI) are indicated. However, it must be considered that a positive thermogram may precede positive results from other objective testing by 5-8 years. Thermology restudy in 90-120 days should be an important part of a comprehensive testing panel to determine time-based evolutionary trends.
The fifth classification in the Marseille system defines two or more thermology criteria. This classification represents a strongly positive result with a very high (approx. 96%) probability of confirming breast cancer. Benign processes or personal variant are very unlikely as a basis for the described abnormal thermology features. A clinical correlation is indicated for skin changes (discoloration or peau d`orange), regional masses and physical distortions (dimpling, bulging or flattening). Clearly, a patient with a TH-5 score is promptly indicated for a comprehensive panel of objective evaluation (targeted ultrasound, X-ray mammography and MRI). A thermology restudy in 90-120 days should be a part of this evaluation in order to determine time-based evolution if these other methods do not demonstrate breast cancer, as thermology may precede other abnormal features by 5-8 years.
This is a specialized and investigational classification that was not part of the original Marseille system and outside the role of thermology as a risk assessment tool for breast cancer. The TH-6 classification is applied to studies that evaluate thermology signs and criteria for women with biopsy-confirmed breast cancer without any form of surgical treatment. Increasingly, women with confirmed breast cancer are treated with various forms of adjunctive chemotherapy and/or radiation prior to surgical excision or, sometimes, without any form of surgical excision. Monitoring changes and trends in the thermology features against those seen in a baseline study can provide a useful adjunct with clinical finding and blood markers to evaluate the effectiveness of the treatment program. This feedback can also indicate the need to modify the treatment program so as not to waste precious time or resources.
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The contents of this site are © Copyrighted 2011 by Therma-Scan Reference Laboratory, LLC. All Rights Strictly Reserved Worldwide.
No images or text in this site may not be reproduced in part or whole in ANY format, electronic or printed without the expressed, prior and written approval of
Therma-Scan Reference Laboratory, LLC.
34100 Woodward Ave. Suite 100 Birmingham, MI 48009 USA.
Therma-Scan is certified facility by the American Academy of Thermology