Infrared Breast Thermography is a safe, non-ionizing, non-contact study of breast skin temperature that is useful in breast health risk assessment and as an adjunct in the detection of physiologic changes associated with breast cancer. Internationally peer reviewed Guidelines for Breast Thermography have been developed by the American Academy of Thermology in 2012.

Thermography measures, images and maps microcirculatory shunting associated with breast circulatory changes in the skin. As with most physiologic studies, anatomic findings may not correlate and may not even be present (physiologic findings tend to predate structural findings). Thermography can however play an important adjunctive role in clinical diagnosis and in distinguishing between benign, early, advanced, and progressive disease.

Breast thermography can also play a useful role in monitoring treatment effects.

Cancer cells need increased blood flow (angiogenesis) in order to “take” over surrounding breast tissue. They also have an increased metabolic rate, which translates into an increase in temperature compared to surrounding normal tissue. By studying breast tissue with infrared imaging early changes in blood flow can be detected and progressive changes can be assessed over time.

In 1997 Gamagami, Silverstein & Waisman published that :

Angiogenesis was the first sign appearing on mammography before the appearance of image of breast cancer, predicting in 91 % of the cases which breast might develop breast carcinoma. This is an important finding in the detection of the early stages of breast cancer development.

Infra-red imaging goes hand in hand with mammography. Hypervascularity and hyperthermia could be shown in 86% of non-palpable breast cancer. In 15% it helped to detect the cancer upon an unsuspicious image on mammography.

Infra-red imaging was found to be the only test showing the efficiency of chemotherapy in inflammatory breast carcinoma.

While Breast Thermography is not a stand alone tool in the diagnosis of breast cancer no screening tool (including X-ray mammography and Ultrasound) provides excellent predictability when used by itself. A combination of tools that incorporates Infrared Thermography has been shown to boost both sensitivity and specificity.

In an 4 year, five institution article published in the American Journal of Radiology (2003) the authors concluded that Infrared Mammography is a safe noninvasive procedure that is valuable as an adjunct to X-Ray Mammography in determining whether a lesion is benign or malignant.

There was 97% sensitivity when identified lesions were biopsied, however only a 14% specificity. This means that Infrared Mammography is very sensitive at breast cancer detection, however identified lesions are most often not cancer (usually they are microcalcifications).

There was also a 95% negative predictive value, and a 24% positive predictive value. This means that if an Infrared Mammogram is negative there is a 95% chance that there is no cancer and that if it is positive that there is a 24% chance that cancer may later be discovered.

Likewise, in 2008 The American Journal of Surgery (pages 523-526) published that Infrared Mammography identified 58 of 60 malignancies, with 97% sensitivity, 44% specificity, and 82% negative predictive value. The authors concluded that Infrared Mammography is a valuable adjunct to X-ray mammography and ultrasound, especially in women with dense breast tissue.

Thermal imaging is an examination of physiology that is complimentary to anatomical imaging techniques. Although proven to be highly accurate, thermal imaging is an adjunctive procedure; and as such, it is not intended to replace anatomic studies such as mammography, ultrasound, MRI, CT, X-ray, or others.

The earliest possible indication of abnormalities allows for the earliest possible intervention.

Breast_Assessment_1

Thermography detects the physiologic changes in the breast tissue that have been shown to correlate with cancerous or pre-cancerous states. It is widely acknowledged that cancers, even in their earliest stages need nutrients to maintain or accelerate their growth. In order to facilitate this process blood vessels are caused to remain open, inactive blood vessels are activated and new ones are formed, a process known as neoangiogenisis. This vascular process causes an increase in surface temperature in the affected regions which can be viewed with infrared imaging cameras. Additionally the newly formed or activated blood vessels have a distinct appearance which thermography can detect.

Thermography is a physiologic test which can demonstrate the aforementioned changes. As such it cannot identify tumors. It provides the clinician with extremely useful information regarding areas of abnormality which can be examined clinically and with anatomic tests. Since thermal imaging detects changes at the cellular level, studies suggest that this test can detect activity eight to ten years BEFORE any other test. This makes it unique in that it affords us the opportunity to view changes before the actual formation of the tumor. Studies have shown that by the time a tumor has grown to sufficient size to be detectable by physical examination or mammography, it has in fact been growing for several years achieving more than twenty-five doublings of the malignant cell colony.

Breast_Assessment_2

 According to the 1998 Merck Manual, for every case of breast cancer diagnosed each year, five to ten women will needlessly undergo a painful breast biopsy. Statistically therefore each woman who undergoes annual screening mammograms for ten years has at least a fifty percent chance of undergoing a breast biopsy. Breast thermography has been researched for over forty years with a data base of over 1/4 million women. There are over 800 peer-reviewed thermographic studies. This research has concluded that a persistently abnormal themogram is consistent with a 22 fold increase in the risk of developing breast cancer. Because of the safety inherent in the test, thermography can be performed on an individual of any age, including those who are pregnant or breast feeding.

Thermography is unaffected by breast density, implants or scars from surgery. It allows for the avoidance of potentially harmful radiation, a known carcinogen. Radiation from routine mammograms poses significant cumulative risk of initiating and promoting breast cancer (1-3) . In fact a mammogram results in 1000 fold greater radiation exposure than a chest x-ray(2). Additionally each rad (radiation absorbed dose) of exposure increases breast cancer risk by one percent annually (4), an extremely worrisome statistic for premenopausal women whose breasts are more sensitive to radiation.

Breast thermography is non-contact test. Conversely, mammography involves placing the breast between two plates and subjecting the breast to painful compression. The recommended force to be used for the compression of breast tissue in a mammogram is 300 Newtons, the equivalent of placing a fifty pound weight on the breast. In an article written in 1928(5) physicians were warned to handle “cancerous breasts with care – for fear of accidentally disseminating cells and spreading cancer.” In 1992 (6) an opinion was offered that such compression might lead to distant and lethal spread of malignant cells by rupturing small blood vessels in or around small, as yet undetected breast cancers.

In 1995, the Lancet, a prestigious British medical journal, reported that “since mammographic screening was introduced in 1983, the incidence of ductal carcinoma in situ “DCIS”, which represents 12% of all breast cancer cases, has increased by 328% and 200% of this increase is due to the use of mammography.

Thermography has been determined to have an average sensitivity and specificity of 90% and when used as part of a comprehensive multi faceted approach can lead to early detection of 95% of early stage cancers. This increases the long term survival rate by as much as 60%.

BIBLIOGRAPHY:

(1-6) Cancer Prevention Coalition

Dangers And Unreliability of Mammography: Breast Examination is a safe, Effective, and Practical Alternative

Samuel S. Epstein, Rosalie Bertell, and Barbara Seanman

International Journal of Health Services, 31(3):605-615, 2001

Breast Thermography Article by Philip Getson, DO and Liesa Getson, CTT:

http://www.tdinj.com/docs/Breast-Thermography.pdf

There are three different thermographic techniques for breast diagnosis: the tele-thermography, the contact thermography and the dynamic angiothermography. These digital infrared imaging thermographic techniques are based on the principle that metabolic activity and vascular circulation in both pre-cancerous tissue and the area surrounding a developing breast cancer is almost always higher than in normal breast tissue. Cancerous tumors require an ever-increasing supply of nutrients and therefore increase circulation to their cells by holding open existing blood vessels, opening dormant vessels, and creating new ones (neo-angiogenesis theory).

Tele-thermography and contact thermography supporters claim this process results in an increase in regional surface temperatures of the breast, however there is little evidence that thermography is an accurate means of identifying breast tumours. Thermography is not approved for breast cancer screening in the United States or Canada, and medical authorities have issued warnings against thermography in both countries.

Dynamic angiothermography utilizes thermal imaging but with important differences with the tele-thermography and contact thermography, that impact detection performance. First, the probes are improved over the previous liquid crystal plates; they include better spatial resolution, contrastive performance, and the image is formed more quickly. The more significant difference lies in identifying the thermal changes due to changes in vascular network to support the growth of the tumor/lesion. Instead of just recording the change in heat generated by the tumor, the image is now able to identify changes due to the vascularization of the mammary gland. It is currently used in combination with other techniques for diagnosis of breast cancer. This diagnostic method is a low cost one compared with other techniques. The angiothermography is not a test that substitutes for other tests, but stands in relation to them as a technique that gives additional information to clarify the clinical picture and improve the quality of diagnosis.

Note: The following is not a comprehensive review of the literature. Over 30 years of research compiling over 800 studies in the index-medicus exist. What follows is a pertinent sample review of the research concerning the clinical application of diagnostic infrared imaging (thermography) for use in breast cancer screening. All the citations are taken from the index-medicus peer-reviewed research literature or medical textbooks. The authors are either PhD’s with their doctorate in a representative field, or physicians primarily in the specialties of oncology, radiology, gynecology, and internal medicine.

The following list is a summary of the informational text that follows:

• In 1982, the FDA approved breast thermography as an adjunctive diagnostic breast cancer screening procedure.
• Breast thermography has undergone extensive research since the late 1950’s.
• Over 800 peer-reviewed studies on breast thermography exist in the index-medicus literature.
• In this database, well over 300,000 women have been included as study participants.
• The numbers of participants in many studies are very large — 10K, 37K, 60K, 85K…
• Some of these studies have followed patients up to 12 years.
• Strict standardized interpretation protocols have been established for over 15 years.
• Breast thermography has an average sensitivity and specificity of 90%.
• An abnormal thermogram is 10 times more significant as a future risk indicator for breast cancer than a first order family history of the disease.
• A persistent abnormal thermogram caries with it a 22x higher risk of future breast cancer.
• An abnormal infrared image is the single most important marker of high risk for developing breast cancer.
• Breast thermography has the ability to detect the first signs that a cancer may be forming up to 10 years before any other procedure can detect it.
• Extensive clinical trials have shown that breast thermography significantly augments the long-term survival rates of its recipients by as much as 61%.
• When used as part of a multimodal approach (clinical examination + mammography + thermography) 95% of early stage cancers will be detected.

Introduction

The first recorded use of thermobiological diagnostics can be found in the writings of Hippocrates around 480 B.C.[1]. A mud slurry spread over the patient was observed for areas that would dry first and was thought to indicate underlying organ pathology. Since this time, continued research and clinical observations proved that certain temperatures related to the human body were indeed indicative of normal and abnormal physiologic processes. In the 1950’s, military research into infrared monitoring systems for night time troop movements ushered in a new era in thermal diagnostics. The first use of diagnostic thermography came in 1957 when R. Lawson discovered that the skin temperature over a cancer in the breast was higher than that of normal tissue[2].

The Department of Health Education and Welfare released a position paper in 1972 in which the director, Thomas Tiernery, wrote, “The medical consultants indicate that thermography, in its present state of development, is beyond the experimental state as a diagnostic procedure in the following 4 areas: 1) Pathology of the female breast. 2)……”. On January 29, 1982, the Food and Drug Administration published its approval and classification of thermography as an adjunctive diagnostic screening procedure for the detection of breast cancer. Since the late 1970’s, numerous medical centers and independent clinics have used thermography for a variety of diagnostic purposes.

Fundamentals of Infrared Imaging

Physics – All objects with a temperature above absolute zero (-273 K) emit infrared radiation from their surface. The Stefan-Boltzmann Law defines the relation between radiated energy and temperature by stating that the total radiation emitted by an object is directly proportional to the object’s area and emissivity and the fourth power of its absolute temperature. Since the emissivity of human skin is extremely high (within 1% of that of a black body), measurements of infrared radiation emitted by the skin can be converted directly into accurate temperature values.

Equipment Considerations – Infrared rays are found in the electromagnetic spectrum within the wavelengths of 0.75 micron – 1mm. Human skin emits infrared radiation mainly in the 2 – 20 micron wavelength range, with an average peak at 9-10 microns[3]. State-of-the-art infrared radiation detection systems utilize ultra-sensitive infrared cameras and sophisticated computers to detect, analyze, and produce high-resolution diagnostic images of these infrared emissions. The problems encountered with first generation infrared camera systems such as improper detector sensitivity (low-band), thermal drift, calibration, analog interface, etc. have been solved for almost two decades.

Laboratory Considerations – Thermographic examinations must be performed in a controlled environment. The primary reason for this is the nature of human physiology. Changes from a different external (non-clinical controlled room) environment, clothing, etc. produce thermal artifacts. Refraining from sun exposure, stimulation or treatment of the breasts, and cosmetics and lotions before the exam, along with 15 minutes of nude acclimation in a florescent lit, draft and sunlight-free, temperature and humidity-controlled room maintained between 18-22 degree C, and kept to within 1 degree C of change during the examination, is necessary to produce a physiologically neutral image free from artifact.

Correlation Between Pathology and Infrared Imaging

The empirical evidence that underlying breast cancer alters regional skin surface temperatures was investigated early on. In 1963, Lawson and Chughtai, two McGill University surgeons, published an elegant intra-operative study demonstrating that the increase in regional skin surface temperature associated with breast cancer was related to venous convection[4]. This early quantitative experiment added credence to previous research suggesting that infrared findings were related to both increased vascular flow and increased metabolism.

Infrared imaging of the breast may have critical prognostic significance since it may correlate with a variety of pathologic prognostic features such as tumor size, tumor grade, lymph node status and markers of tumor growth[5]. The pathologic basis for these infrared findings, however, is uncertain. One possibility is increased blood flow due to vascular proliferation (assessed by quantifying the microvascular density (MVD)) as a result of tumor associated angiogenesis. Although in one study[6], the MVD did not correlate with abnormal infrared findings. However, the imaging method used in that study consisted of contact plate technology (liquid crystal thermography (LCT)), which is not capable of modern computerized infrared analysis. Consequently, LCT does not possess the discrimination and digital processing necessary to begin to correlate histological and discrete vascular changes[7].

In 1993, Head and Elliott reported that improved images from second generation infrared systems allowed more objective and quantitative analysis[5], and indicated that growth-rate related prognostic indicators were strongly associated with the infrared image interpretation.

In a 1994 detailed review of the potential of infrared imaging[8], Anbar suggested, using an elegant biochemical and immunological cascade, that the previous empirical observation that small tumors were capable of producing notable infrared changes could be due to enhanced perfusion over a substantial area of the breast surface via regional tumor induced nitric oxide vasodilatation. Nitric oxide is a molecule with potent vasodilating properties. It is synthesized by nitric oxide synthase (NOS), found both as a constitutive form of nitric oxide synthase (c-NOS), especially in endothelial cells, and as an inducible form of nitric oxide synthase (i-NOS), especially in macrophages[9]. NOS has been demonstrated in breast carcinoma[10] using tissue immunohistochemistry, and is associated with a high tumor grade. There have been, however, no previous studies correlating tissue NOS levels with infrared imaging. Given the correlation between infrared imaging and tumor grade, as well as NOS levels and tumor grade, it is possible that infrared findings may correlate with tumor NOS content. Future studies are planned to investigate these possible associations.

The concept of angiogenesis, as an integral part of early breast cancer, was emphasized in 1996 by Guido and Schnitt. Their observations suggested that it is an early event in the development of breast cancer and may occur before tumor cells acquire the ability to invade the surrounding stroma and even before there is morphologic evidence of an in-situ carcinoma[11]. Anti-angiogenesis therapy is now one of the most promising therapeutic strategies and has been found to be pivotal in the new paradigm for consideration of breast cancer development and treatment[12]. In 1996, in his highly reviewed textbook entitled Atlas of Mammography – New Early Signs in Breast Cancer, Gamagami studied angiogenesis by infrared imaging and reported that hypervascularity and hyperthermia could be shown in 86% of non-palpable breast cancers. He also noted that in 15% of these cases infrared imaging helped to detect cancers that were not visible on mammography[13].

The underlying principle by which thermography (infrared imaging) detects pre-cancerous growths and cancerous tumors surrounds the well documented recruitment of existing vascularity and neoangiogenesis which is necessary to maintain the increased metabolism of cellular growth and multiplication. The biomedical engineering evidence of thermography’s value, both in model in-vitro and clinically in-vivo studies of various tissue growths, normal and neoplastic, has been established[14-20].

The Role of Infrared Imaging in the Detection of Cancer

In order to evaluate the value of thermography, two viewpoints must be considered: first, the sensitivity of thermograms taken preoperatively in patients with known breast carcinoma, and second, the incidence of normal and abnormal thermograms in asymptomatic populations (specificity) and the presence or absence of carcinoma in each of these groups.

In 1965, Gershon-Cohen, a radiologist and researcher from the Albert Einstein Medical Center, introduced infrared imaging to the United States[21]. Using a Barnes thermograph, he reported on 4,000 cases with a sensitivity of 94% and a false-positive rate of 6%. This data was included in a review of the then current status of infrared imaging published in 1968 in CA – A Cancer Journal for Physicians[22].

In prospective studies, Hoffman first reported on thermography in a gynecologic practice. He detected 23 carcinomas in 1,924 patients (a detection rate of 12.5 per 1,000), with an 8.4% false-negative (91.6% sensitivity) and a 7.4% false-positive (92.6% specificity) rate[23].

Stark and Way screened 4,621 asymptomatic women, 35% of whom were under 35 years of age, and detected 24 cancers (detection rate of 7.6 per 1,000), with a sensitivity and specificity of 98.3% and 93.5% respectively[24].

In a mobile unit examination of rural Wisconsin, Hobbins screened 37,506 women using thermography. He reported the detection of 5.7 cancers per 1,000 women screened with a 12% false-negative and 14% false-positive rate. His findings also corroborated with others that thermography is the sole early initial signal in 10% of breast cancers[25-26].

Reporting his Radiology division’s experience with 10,000 thermographic studies done concomitantly with mammography over a 3 year period, Isard reiterated a number of important concepts including the remarkable thermal and vascular stability of the infrared image from year to year in the otherwise healthy patient and the importance of recognizing any significant change[27]. In his experience, combining these modalities increased the sensitivity rate of detection by approximately 10%; thus, underlining the complementarity of these procedures since each one did not always suspect the same lesion. It was Isard’s conclusion that, had there been a preliminary selection of his group of 4,393 asymptomatic patients by infrared imaging, mammographic examination would have been restricted to the 1,028 patients with abnormal infrared imaging, or 23% of this cohort. This would have resulted in a cancer detection rate of 24.1 per 1000 combined infrared and mammographic examinations as contrasted to the expected 7 per 1000 by mammographic screening alone. He concluded that since infrared imaging is an innocuous examination, it could be utilized to focus attention upon asymptomatic women who should be examined more intensely. Isard emphasized that, like mammography and other breast imaging techniques, infrared imaging does not diagnose cancer, but merely indicates the presence of an abnormality.

Spitalier and associates screened 61,000 women using thermography over a 10 year period. The false-negative and positive rate was found to be 11% (89% sensitivity and specificity). 91% of the nonpalpable cancers (T0 rating) were detected by thermography. Of all the patients with cancer, thermography alone was the first alarm in 60% of the cases. The authors also noted that “in patients having no clinical or radiographic suspicion of malignancy, a persistently abnormal breast thermogram represents the highest known risk factor for the future development of breast cancer”[28].

Two small-scale studies by Moskowitz (150 patients)[29] and Treatt (515 patients)[30] reported on the sensitivity and reliability of infrared imaging. Both used unknown “experts” to review the images of breast cancer patients. While Moskowitz excluded unreadable images, data from Threatt’s study indicated that less than 30% of the images produced were considered good, the rest being substandard. Both of these studies produced poor results; however, this could be expected from the fact alone that both used such a small patient base. However, the greatest error in these studies is found in the methods used to analyze the images. The type of image analysis consisted of the sole use of abnormal vascular pattern recognition. At the time these studies were performed, the most recognized method of infrared image analysis used a combination of abnormal vascular patterns with a quantitative analysis of temperature variations across the breasts. Consequently, the data obtained from these studies is highly questionable. Their findings were also inconsistent with numerous previous large-scale multi-center trials. The authors suggested that for infrared imaging to be truly effective as a screening tool, there needed to be a more objective means of interpretation and proposed that this would be facilitated by computerized evaluation. This statement is interesting considering that the use of recognized quantitative and qualitative reading protocols (including computer analysis) was available at the time.

In a unique study comprising 39,802 women screened over a 3 year period, Haberman and associates used thermography and physical examination to determine if mammography was recommended. They reported an 85% sensitivity and 70% specificity for thermography. Haberman cautioned that the findings of thermographic specificity could not be extrapolated from this study as it was well documented that long term observation (8-10 years or more) is necessary to determine a true false-positive rate. The authors noted that 30% of the cancers found would not have been detected if it were not for thermography[31].

Gros and Gautherie reported on 85,000 patients screened with a resultant 90% sensitivity and 88% specificity. In order to investigate a method of increasing the sensitivity of the test, 10,834 patients were examined with the addition of a cold-challenge (two types: fan and ice water) in order to elicit an autonomic response. This form of dynamic thermography decreased the false-positive rate to 3.5% (96.5% sensitivity)[32-35].

In a large scale multi-center review of nearly 70,000 women screened, Jones reported a false-negative and false-positive rate of 13% ( 87% sensitivity) and 15% (85% sensitivity) respectively for thermography[36].

In a study performed in 1986, Usuki reported on the relation of thermographic findings in breast cancer diagnosis. He noted an 88% sensitivity for thermography in the detection of breast cancers[37].

In a study comparing clinical examination, mammography, and thermography in the diagnosis of breast cancer, three groups of patients were used: 4,716 patients with confirmed carcinoma, 3,305 patients with histologically diagnosed benign breast disease, and 8,757 general patients (16,778 total participants). This paper also compared clinical examination and mammography to other well known studies in the literature including the NCI-sponsored Breast Cancer Detection Demonstration Projects. In this study, clinical examination had an average sensitivity of 75% in detecting all tumors and 50% in cancers less than 2 cm in size. This rate is exceptionally good when compared to many other studies at between 35-66% sensitivity. Mammography was found to have an average 80% sensitivity and 73% specificity. Thermography had an average sensitivity of 88% (85% in tumors less than 1 cm in size) and a specificity of 85%. An abnormal thermogram was found to have a 94% predictive value. From the findings in this study, the authors suggested that “none of the techniques available for screening for breast carcinoma and evaluating patients with breast related symptoms is sufficiently accurate to be used alone. For the best results, a multimodal approach should be used”[38].

In a series of 4,000 confirmed breast cancers, Thomassin and associates observed 130 sub-clinical carcinomas ranging in diameter of 3-5 mm. Both mammography and thermography were used alone and in combination. Of the 130 cancers, 10% were detected by mammography only, 50% by thermography alone, and 40% by both techniques. Thus, there was a thermal alarm in 90% of the patients and the only sign in 50% of the cases[39].

In a study by Gautherie and associates, the effectiveness of thermography in terms of survival benefit was discussed. The authors analyzed the survival rates of 106 patients in whom the diagnosis of breast cancer was established as a result of the follow-up of thermographic abnormalities found on the initial examination when the breasts were apparently healthy (negative physical and mammographic findings). The control group consisted of 372 breast cancer patients. The patients in both groups were subjected to identical treatment and followed for 5 years. A 61% increase in survival was noted in the patients who were followed-up due to initial thermographic abnormalities. The authors summarized the study by stating that “the findings clearly establish that the early identification of women at high risk of breast cancer based on the objective thermal assessment of breast health results in a dramatic survival benefit”[40-41].

In a simple review of over 15 studies from 1967–1998, breast thermography has showed an average sensitivity and specificity of 90%. With continued technological advances in infrared imaging in the past decade, some studies are showing even higher sensitivity and specificity values. However, until further large scale studies are performed, these findings remain in question.

Breast Cancer Detection and Demonstration Projects

The Breast Cancer Detection and Demonstration Project (BCDDP) is the most frequently quoted reason for the decreased use of infrared imaging. The BCDDP was a large-scale study performed from 1973 through 1979 which collected data from many centers around the United States. Three methods of breast cancer detection were studied: physical examination, mammography, and infrared imaging (breast thermography).

Inflated Expectations – Just before the onset of the BCDDP, two important papers appeared in the literature. In 1972, Gerald D. Dodd of the University of Texas Department of Diagnostic Radiology presented an update on infrared imaging in breast cancer diagnosis at the 7th National Cancer Conference sponsored by the National Cancer Society and the National Cancer Institute[42]. In his presentation, he suggested that infrared imaging would be best employed as a screening agent for mammography. He proposed that in any general survey of the female population age 40 and over, 15 to 20% of these subjects would have positive infrared imaging and would require mammograms. Of these, approximately 5% would be recommended for biopsy. He concluded that infrared imaging would serve to eliminate 80 to 85% of the potential mammograms. Dodd also reiterated that the procedure was not competitive with mammography and, reporting the Texas Medical School’s experience with infrared imaging, noted that it was capable of detecting approximately 85% of all breast cancers. Dodd’s ideas would later help to fuel the premise and attitudes incorporated into the BCDDP. Three years later, J.D. Wallace presented to another Cancer Conference, sponsored by the American College of Radiology, the American Cancer Society and the Cancer Control Program of the National Cancer Institute, an update on infrared imaging of the breast[43]. The author’s analysis suggested that the incidence of breast cancer detection per 1000 patients screened could increase from 2.72 when using mammography to 19 when using infrared imaging. He then underlined that infrared imaging poses no radiation burden on the patient, requires no physical contact and, being an innocuous technique, could concentrate the sought population by a significant factor selecting those patients that required further investigation. He concluded that, “the resulting infrared image contains only a small amount of information as compared to the mammogram, so that the reading of the infrared image is a substantially simpler task”.

Faulty Premise – Unfortunately, this rather simplistic and cavalier attitude toward the generation and interpretation of infrared imaging was prevalent when it was hastily added and then prematurely dismissed from the BCDDP which was just getting underway. Exaggerated expectations led to the ill-founded premise that infrared imaging might replace mammography rather than complement it. A detailed review of the Report of the Working Group of the BCDDP, published in 1979, is essential to understand the subsequent evolution of infrared imaging[44]. The work scope of this project was issued by the NCI on the 26th of March 1973 with six objectives, the second being to determine if a negative infrared image was sufficient to preclude the use of clinical examination and mammography in the detection of breast cancer. The Working Group, reporting on results of the first four years of this project, gave a short history regarding infrared imaging in breast cancer detection. They wrote that as of the sixties, there was intense interest in determining the suitability of infrared imaging for large-scale applications, and mass screening was one possibility. The need for technological improvement was recognized and the authors stated that efforts had been made to refine the technique. One of the important objectives behind these efforts had been to achieve a sufficiently high sensitivity and specificity for infrared imaging under screening conditions to make it useful as a pre-screening device in selecting patients for referral for mammographic examination. It was thought that if successful, this technology would result in a relatively small proportion of women having mammography (a technique that had caused concern at that time because of the carcinogenic effects of radiation). The Working Group indicated that the sensitivity and specificity of infrared imaging readings, with clinical data emanating from inter-institutional studies, were close to the corresponding results for physical examination and mammography. They noted that these three modalities selected different sub-groups of breast cancers, and for this reason further evaluation of infrared imaging as a screening device in a controlled clinical trial was recommended.

Poor Study Design – While this report describes in detail the importance of quality control of mammography, the entire protocol for infrared imaging was summarized in one paragraph and simply indicated that infrared imaging was conducted by a BCDDP trained technician. The detailed extensive results from this report, consisting of over 50 tables, included only one that referred to infrared imaging showing that it had detected only 41% of the breast cancers during the first screening while the residual were either normal or unknown. There is no breakdown as far as these two latter groups were concerned. Since 28% of the first screening and 32% of the second screening were picked up by mammography alone, infrared imaging was dropped from any further evaluation and consideration. The report stated that it was impossible to determine whether abnormal infrared imaging could be predictive of interval cancers (cancers developing between screenings) since they did not collect this data. By the same token, the Working Group was unable to conclude, with their limited experience, whether the findings were related to the then available technology of infrared imaging or with its application. They did, however, conclude that the decision to dismiss infrared imaging should not be taken as a determination of the future of this technique, rather that the procedure continued to be of interest because it does not entail the risk of radiation exposure. In the Working Group’s final recommendation, they state that “infrared imaging does not appear to be suitable as a substitute for mammography for routine screening in the BCDDP.” The report admitted that several individual programs of the BCDDP had results that were more favorable than what was reported for the BCDDP as a whole. They encouraged investment in the development and testing of infrared imaging under carefully controlled study conditions and suggested that high priority be given to these studies. They noted that a few suitable sites appeared to be available within the BCDDP participants and proposed that developmental studies should be solicited from sites with sufficient experience.

Untrained Personnel and Protocol Violations – JoAnn Haberman, who was a participant in this project[45], provided further insight into the relatively simplistic regard assigned to infrared imaging during this program. The author reiterated that expertise in mammography was an absolute requirement for the awarding of a contract to establish a Screening Center. However, the situation was just the opposite with regard to infrared imaging – no experience was required at all. When the 27 demonstration project centers opened their doors, only 5 had any pre-existing expertise in infrared imaging. Of the remaining screening centers, there was no experience at all in this technology. Finally, more than 18 months after the project had begun, the NCI established centers where radiologists and their technicians could obtain sufficient training in infrared imaging. Unfortunately, only 11 of the demonstration project directors considered this training of sufficient importance to send their technologists to learn proper infrared technique. The imaging sites also disregarded environmental controls. Many of the project sites were mobile imaging vans which had poor heating and cooling capabilities and often kept their doors open in the front and rear to permit an easy flow of patients. This, combined with a lack of pre-imaging patient acclimation, lead to unreadable images.

In summary, with regard to thermography, the BCDDP was plagued with problems and seriously flawed in four critical areas: 1) Completely untrained technicians were used to perform the scans, 2) The study used radiologists who had no experience or knowledge in reading infrared images, 3) Proper laboratory environmental controls were completely ignored. In fact, many of the research sites were mobile trailers with extreme variations in internal temperatures, 4) No standardized reading protocol had yet been established for infrared imaging. The BCDDP was also initiated with an incorrect premise that thermography might replace mammography. From a purely scientific point, an anatomical imaging procedure (mammography) cannot be replaced by a physiological one. Last of all, and of considerable concern, was the reading of the images. It wasn’t until the early 1980’s that established and standardized reading protocols were introduced. Considering these facts, the BCDDP could not have properly evaluated infrared imaging. With the advent of known laboratory environmental controls, established reading protocols, and state-of-the-art infrared technology, a poorly performed 20-year-old study cannot be used to determine the appropriateness of thermography.

Thermography as a Risk Indicator

As early as 1976, at the Third International Symposium on Detection and Prevention of Cancer in New York, thermography was established by consensus as the highest risk marker for the possibility of the presence of an undetected breast cancer. It had also been shown to predict such a subsequent occurrence[46-48]. The Wisconsin Breast Cancer Detection Foundation presented a summary of its findings in this area, which has remained undisputed[49]. This, combined with other reports, has confirmed that thermography is the highest risk indicator for the future development of breast cancer and is 10 times as significant as a first order family history of the disease[50].

In a study of 10,000 women screened, Gautherie found that, when applied to asymptomatic women, thermography was very useful in assessing the risk of cancer by dividing patients into low- and high-risk categories. This was based on an objective evaluation of each patient’s thermograms using an improved reading protocol that incorporated 20 thermopathological factors[51].

From a patient base of 58,000 women screened with thermography, Gros and associates followed 1,527 patients with initially healthy breasts and abnormal thermograms for 12 years. Of this group, 40% developed malignancies within 5 years. The study concluded that “an abnormal thermogram is the single most important marker of high risk for the future development of breast cancer”[35].

Spitalier and associates followed 1,416 patients with isolated abnormal breast thermograms. It was found that a persistently abnormal thermogram, as an isolated phenomenon, is associated with an actuarial breast cancer risk of 26% at 5 years. Within this study, 165 patients with non-palpable cancers were observed. In 53% of these patients, thermography was the only test which was positive at the time of initial evaluation. It was concluded that: 1) A persistently abnormal thermogram, even in the absence of any other sign of malignancy, is associated with a high risk of developing cancer, 2) This isolated abnormal also carries with it a high risk of developing interval cancer, and as such the patient should be examined more frequently than the customary 12 months, 3) Most patients diagnosed as having minimal breast cancer have abnormal thermograms as the first warning sign[52-53].

Current Status of Detection

Current first-line breast cancer detection strategy still depends essentially on clinical examination and mammography. The limitations of the former, with its reported sensitivity rate often below 65%[54] is well-recognized, and even the proposed value of self-breast examination is now being contested[55]. While mammography is accepted as the most reliable and cost-effective imaging modality, its contribution continues to be challenged with persistent false-negative rates ranging up to 30% [56-57]; with decreasing sensitivity in patients on estrogen replacement therapy[58]. In addition, there is recent data suggesting that denser and less informative mammography images are precisely those associated with an increased cancer risk[59]. Echoing some of the shortcomings of the BCDDP concerning their study design and infrared imaging, Moskowitz indicated that mammography is also not a procedure to be performed by the untutored[60].

With the current emphasis on earlier detection, there is now renewed interest in the parallel development of complimentary imaging techniques that can also exploit the precocious metabolic, immunological and vascular changes associated with early tumor growth. While promising, techniques such as scintimammography[61], doppler ultrasound[62], and MRI[63], are associated with a number of disadvantages that include exam duration, limited accessibility, need of intravenous access, patient discomfort, restricted imaging area, difficult interpretation and limited availability of the technology. Like ultrasound, they are more suited to use as second-line options to pursue the already abnormal clinical or mammographic evaluation. While practical, this step-wise approach currently results in the non-recognition, and thus delayed utilization of second-line technology in approximately 10% of established breast cancers[60]. This is consistent with study published by Keyserlingk et al[64].

Because of thermography’s unique ability to image the thermovascular aspects of the breast, extremely early warning signals (from 8-10 years before any other detection method) have been observed in long-term studies. Consequently, thermography is the earliest known indicator for the future development of breast cancer. It is for this reason that an abnormal infrared image is the single most important marker of high risk for developing breast cancer. Thus, thermography has a significant place as one of the major front-line methods of breast cancer detection.

Conclusion

The large patient populations and long survey periods in many of the above clinical studies yields a high significance to the various statistical data obtained. This is especially true for the contribution of thermography to early cancer diagnosis, as an invaluable marker of high-risk populations, and therapeutic decision making (a contribution that has been established and justified by the unequivocal relationship between heat production and tumor doubling time).

Currently available high-resolution digital infrared imaging (Thermography) technology benefits greatly from enhanced image production, standardized image interpretation protocols, computerized comparison and storage, and sophisticated image enhancement and analysis. Over 30 years of research and 800 peer-reviewed studies encompassing well over 300,000 women participants has demonstrated thermography’s abilities in the early detection of breast cancer. Ongoing research into the thermal characteristics of breast pathologies will continue to investigate the relationships between neoangiogenesis, chemical mediators, and the neoplastic process.

It is unfortunate, but many physicians still hesitate to consider thermography as a useful tool in clinical practice in spite of the considerable research database, continued improvements in both thermographic technology and image analysis, and continued efforts on the part of the thermographic societies. This attitude may be due to the fact that the physical and biological bases of thermography are not familiar to most physicians. The other methods of cancer investigations refer directly to topics of medical teaching. For instance, radiography and ultrasonography refer to anatomy. Thermography, however, is based on thermodynamics and thermokinetics, which are unfamiliar to most physicians, though man is experiencing heat production and exchange in every situation he undergoes or creates.

Considering the contribution that thermography has demonstrated thus far in the field of early cancer detection, all possibilities should be considered for promoting further technical, biological, and clinical research in this procedure.

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[5] Head JF, Wang F, Elliott RL: Breast thermography is a noninvasive prognostic procedure that predicts tumor growth rate in breast cancer patients. Ann N Y Acad Sci 698:153-158,1993.

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[7] Head JF, Elliott RL: Breast Thermography. Cancer 79:186-8,1995.

[8] Anbar M: Breast Cancer. In: Quantitative Dynamic Telethermometry in Medical Diagnosis and Management. CRC Press, Ann Arbor, Mich, pp.84-94, 1994.

[9] Rodenberg DA, Chaet MS, Bass RC, Arkovitz MD and Garcia BF. Nitric Oxide: An overview. Am J Surg 170:292-303,1995.

[10] Thomsen LL, Miles DW, Happerfield L, Bobrow LG, Knowles RG and Mancada S. Nitric oxide synthase activity in human breast cancer. Br J Cancer 72(1);41-4,July 1995.

[11] Guidi AJ, Schnitt SJ: Angiogenesis in pre-invasive lesions of the breast. The Breast J (2): 364-369, 1996.

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[13] Gamagami P: Indirect signs of breast cancer: Angiogenesis study. In: Atlas of Mammography, Cambridge, Mass.,Blackwell Science pp.231-26, 1996.

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[15] Chato, J.: Measurement of Thermal Properties of Growing Tumors. Proc NY Acad Sci 335:67-85,1980.

[16] Draper, J. : Skin Temperature Distribution Over Veins and Tumors. Phys Med Biol 16(4):645-654,1971

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[18] Gautherie, M.: Thermopathology of Breast Cancer; Measurement and Analysis of In-Vivo Temperature and Blood Flow. Ann NY Acad Sci 365:383, 1980

[19] Gautherie, M.: Thermobiological Assessment of Benign and Malignant Breast Diseases. Am J Obstet Gynecol (8)147:861-869, 1983

[20] Gamigami, P.: Atlas of Mammography: New Early Signs in Breast Cancer. Blackwell Science, 1996. [21] Gershen-Cohen J, Haberman J, Brueschke EE: Medical thermography: A summary of current status. Radiol Clin North Am 3:403-431, 1965.

[22] Haberman J: The present status of mammary thermography. In: Ca – A Cancer Journal for Clinicians 18: 314-321,1968.

[23] Hoffman, R.: Thermography in the Detection of Breast Malignancy. Am J Obstet Gynecol 98:681-686, 1967

[24] Stark, A., Way, S.: The Screening of Well Women for the Early Detection of Breast Cancer Using Clinical Examination with Thermography and Mammography. Cancer 33:1671-1679, 1974

[25] Hobbins, W.: Mass Breast Cancer Screening. Proceedings, Third International Symposium on Detection and Prevention of Breast Cancer, New York City, NY: pg. 637, 1976.

[26] Hobbins, W.: Abnormal Thermogram — Significance in Breast Cancer. RIR 12: 337-343, 1987 [27] Isard HJ, Becker W, Shilo R et al: Breast thermography after four years and 10,000 studies. Am J Roentgenol 115: 811-821,1972.

[28] Spitalier, H., Giraud, D., et al: Does Infrared Thermography Truly Have a Role in Present-Day Breast Cancer Management? Biomedical Thermology, Alan R. Liss New York, NY. pp. 269-278, 1982 [29] Moskowitz M, Milbrath J, Gartside P et al: Lack of efficacy of thermography as a screening tool for minimal and Stage I Breast Cancer. N Engl J Med 295; 249-252,1976.

[30] Threatt B, Norbeck JM, Ullman NS, et al: Thermography and breast cancer: an analysis of a blind reading. Annals N Y Acad Sci 335: 501-519,1980.

[31] Haberman, J., Francis, J., Love, T.: Screening a Rural Population for Breast Cancer Using Thermography and Physical Examination Techniques. Ann NY Acad Sci 335:492-500,1980

[32] Sciarra, J.: Breast Cancer: Strategies for Early Detection. Thermal Assessment of Breast Health. (Proceedings of the International Conference on Thermal Assessment of Breast Health). MTP Press LTD. pp. 117-129, 1983.

[33] Gautherie, M.: Thermobiological Assessment of Benign and Malignant Breast Diseases. Am J Obstet Gynecol (8)147:861-869, 1983.

[34] Louis, K., Walter, J., Gautherie, M.: Long-Term Assessment of Breast Cancer Risk by Thermal Imaging. Biomedical Thermology. Alan R. Liss Inc. pp.279-301, 1982.

[35] Gros, C., Gautherie, M.: Breast Thermography and Cancer Risk Prediction. Cancer 45:51-56, 1980      [36] Jones CH: Thermography of the Female Breast. In: C.A. Parsons (Ed) Diagnosis of Breast Disease, University Park Press, Baltimore, pp. 214-234,1983.

[37] Useki H: Evaluation of the thermographic diagnosis of breast disease: relation of thermographic findings and pathologic findings of cancer growth. Nippon Gan Chiryo Gakkai Shi 23: 2687-2695, 1988.

[38] Nyirjesy, I., Ayme, Y., et al: Clinical Evaluation, Mammography, and Thermography in the Diagnosis of Breast Carcinoma. Thermology 1:170-173, 1986

[39] Thomassin, L., Giraud, D. et al: Detection of Subclinical Breast Cancers by Infrared Thermography. Recent Advances in Medical Thermology (Proceedings of the Third International Congress of Thermology), Plenum Press, New York, NY. pp.575-579, 1984

[40] Gautherie, M., et al: Thermobiological Assessment of Benign and Malignant Breast Diseases. Am J Obstet Gynecol (8)147:861-869, 1983.

[41] Jay, E.; Karpman, H.: Computerized Breast Thermography. Thermal Assessment of Breast Health (Proceedings of an International Conference), MTP Press Ltd., pp.98-109, 1983 [42] Dodd GD: Thermography in Breast Cancer Diagnosis. In: Abstracts for the Seventh National Cancer Conference Proceedings. Los Angeles, Calif., Sept. 27-29, Lippincott Philadelphia, Toronto: pp.267,1972.

[43] Wallace JD: Thermographic examination of the breast: An assessment of its present capabilities. In: Gallagher HS (Ed): Early Breast Cancer: Detection and Treatment. American College of Radiology, Wiley, New York: Wiley, pp. 13-19,1975.

[44] Report of the Working Group to Review the National Cancer Institute Breast Cancer Detection Demonstration Projects. J Natl Cancer Inst 62: 641-709,1979.

[45] Haberman J: An overview of breast thermography in the United States: In: Margaret Abernathy, Sumio Uematsu (Eds): Medical Thermography. American Academy of Thermology, Washington, pp.218-223, 1986.

[46] Amalric, R., Gautherie, M., Hobbins, W., Stark, A.: The Future of Women with an Isolated Abnormal Infrared Thermogram. La Nouvelle Presse Med 10(38):3153-3159, 1981

[47] Gautherie, M., Gros, C.: Contribution of Infrared Thermography to Early Diagnosis, Pretherapeutic Prognosis, and Post-irradiation Follow-up of Breast Carcinomas. Laboratory of Electroradiology, Faculty of Medicine, Louis Pasteur University, Strasbourg, France, 1976

[48] Hobbins, W.: Significance of an “Isolated” Abnormal Thermogram. La Nouvelle Presse Medicale 10(38):3153-3155, 1981

[49] Hobbins, W.: Thermography, Highest Risk Marker in Breast Cancer. Proceedings of the Gynecological Society for the Study of Breast Disease. pp. 267-282, 1977.

[50] Louis, K., Walter, J., Gautherie, M.: Long-Term Assessment of Breast Cancer Risk by Thermal Imaging. Biomedical Thermology. Alan R. Liss Inc. pp.279-301, 1982.

[51] Gauthrie, M.: Improved System for the Objective Evaluation of Breast Thermograms. Biomedical Thermology; Alan R. Liss, Inc., New York, NY; pp.897-905, 1982

[52] Amalric, R., Giraud, D., et al: Combined Diagnosis of Small Breast Cancer. Acta Thermographica, 1984.

[53] Spitalier, J., Amalric, D., et al: The Importance of Infrared Thermography in the Early Suspicion and Detection of Minimal Breast Cancer. Thermal Assessment of Breast Health (Proceedings of an International Conference), MTP Press Ltd., pp.173-179, 1983

[54] Sickles EA: Mammographic features of “early” breast cancer. Am J Roentgenol 143:461, 1984. [55] Thomas DB, Gao DL, Self SG et al: Randomized trial of breast self-examination in Shanghai: Methodology and Preliminary Results. J Natl Cancer Inst 5:355-65, 1997.

[56] Moskowitz M: Screening for breast cancer. How effective are our tests? CA Cancer J Clin 33:26,1983.

[57] Elmore JG, Wells CF, Carol MPH et al. Variability in radiologists interpretation of mammograms. NEJM 331(22):1994;1493

[58] Laya MB: Effect on estrogen replacement therapy on the specificity and sensitivity of screening mammography. J Natl Cancer Inst 88:643-649, 1996.

[59] Boyd NF, Byng JW, Jong RA et al: Quantitative classification of mammographic densities and breast cancer risk. J Natl Cancer Inst 87:670-75,1995.

[60] Moskowitz M: Breast Imaging. In: Donegan WL, Spratt JS (Eds): Cancer of the breast. Saunders, New York, pp.206-239, 1995.

[61] Khalkhali I, Cutrone JA et al: Scintimammography: the complementary role of Tc-99m sestamibi prone breast imaging for the diagnosis of breast carcinoma. Radiol 196: 421-426, 1995.

[62] Kedar RP, Cosgrove DO et al: Breast carcinoma: measurement of tumor response in primary medical therapy with color doppler flow imaging. Radiol 190: 825-830, 1994. [63] Weinreb JC, Newstead G: MR imaging of the breast. Radiol 196: 593-610, 1995.

[64] Keyserlingk JR, Ahlgren, PD, Yu E and Belliveau N: Infrared imaging of the breast: Initial reappraisal using high-resolution digital technology in 100 successive cases of Stage I and II breast cancer. The Breast Journal (4):245-251,1998.

William C. Amalu, DC, DIACT (B), FIACT

© 2002 International Academy of Clinical Thermography

The following are uses of neuromuscular thermography when anatomic tests (CT, myelogram and/or MRI) have not been performed, or are negative or inconclusive:

• To evaluate sensory/autonomic peripheral nerve injury
• To evaluate for the possibility of Reflex Sympathetic Dystrophy/Complex Regional Pain Syndrome or other autonomic dystrophy and to monitor the treatment of same.
• To evaluate and monitor myofascial injury.
• Differentiate, document, and monitor any neuromuscular injury that does not respond to clinical treatment.
• To identify occult myofascial conditions versus symptom magnification.
• To evaluate facial or temporomandibular joint pain when other tests are unrevealing. If the tests of neurophysiology (thermogram and EMG) have been done first, and are negative, the need for anatomic testing may be reconsidered.

The following are uses of neuromuscular thermography when anatomic tests (CT, Myelogram, and/or MRI) have been performed and are positive:

• To evaluate the significance of positive findings when the physical exam or history do not coincide, i.e., a lesion may be present anatomically, but have no significance physiologically.
• To look for hidden or missed lesions. Examples:
• The CT may be abnormal at one level, but the thermogram may show abnormality at this and an adjacent level, leading the physician to order another test, such as a myelogram or MRI, which may uncover a second lesion.
• The patient may have nerve dysfunction and Reflex Sympathetic Dystrophy/Complex Regional Pain Syndrome, with only one set of presenting symptoms.
• The patient may have both nerve problems (disc), and trigger points or facet joint problems, with overlapping or masking of symptoms. Under these circumstances, history and/or symptoms can be masked by the predominant lesion.

• To evaluate the significance of equivocal or mild disc bulges or herniations on myelograms, CT or MRI scans if clinically indicated.
• To evaluate for the possibility of Reflex Sympathetic Dystrophy/Complex Regional Pain Syndrome, and to monitor treatment of same if clinically indicated.
•  Differentiate, document, and monitor any neuromuscular injury that does not respond to clinical treatment.

Chronic pain and its cause is one of the most difficult diagnostic problems plaguing physicians today. Frequently patient’s tests do not correlate with their symptoms. Individuals with radicular symptomatology may have more than one etiology for their problem. The combined use of anatomic and physiologic testing has long been common in the medical community. However until now the physiologic test of choice has been electromyography (EMG) which studies the motor function of nerve and not its sensory component.

Thermography is a physiologic test (rather than an anatomic one) that measures the autonomic nervous system. While other physiologic tests exist they do not monitor the pathways in the same fashion as thermography. It is my opinion that thermography is the BEST diagnostic tool for the evaluation of individuals suspected of having Reflex Sympathetic Dystrophy/Complex Regional Pain Syndrome (RSD/CRPS). In addition to the discomfort inherent in EMG’s the inability of the study to provide adequate information in many cases leads to an incomplete diagnosis. Utilizing non-invasive (and therefore not painful) thermal imaging even more information is available to assist us in the treatment of these individuals. Additionally thermal imaging can be used to monitor the effectiveness of various interventional pain management techniques by using a safe, highly reproducible, sensitive, and accurate diagnostic tool This includes the use of thermal imaging in the positioning of spinal cord stimulators which has increased the accuracy of lead placement. Thermography can detect alterations in the heat patterns of limbs to suggest that there are damaged leads thereby differentiating between an increased pain state and an equipment malfunction. Localization of trigger points by thermographic means has been shown to increase the effectiveness of injections into these areas.

pain_2

 A study currently in progress suggests that Thermography can predict the spread of RSD before it actually occurs, thereby allowing for the earliest possible intervention.

Thoracic outlet syndrome can be demonstrated in real time or by static images using our thermographic apparatus.

A Physician’s Opinion

By Philip Getson, DO

This article appeared in the Pain Practitioner, The Journal of The American Academy of Pain Management, Vol. 16, No. 1, 2006

CPRS

Experts who evaluate patients with CRPS [Complex Regional Pain Syndrome] make the diagnosis based upon history and physical examination. However, because of the wide variation in symptom complexes, not every individual presents with the “classic” symptoms that are frequently associated with CRPS (e.g., temperature change, color change, and hair growth change).

In the past, attempts have been made to diagnosis CRPS with triple phase bone scans. Some literature suggests that these are about 40% accurate, but I believe that in reality the number is closer to 15%. This test is frequently non-specific in its representation, and rarely do radiologists offer a diagnosis of CRPS when they have not been provided with that historical information. Electrodiagnostic testing (EMGs), CAT Scans, MRIs, etc., have no appreciable value in assisting in the diagnosis of CRPS.

Thermography has been utilized in medical application since the 1950s. Prior to that it had, and still does have, industrial applications. The use of infrared imaging for neuromuscular purposes dates back to the 1960’s and has continued despite lack of widespread acceptance. Numerous articles have been written regarding the value of thermography in the diagnosis of sympathetically mediated pain syndromes and work in this area continues. The July 2002 United States Department of Health and Human Services document on Reflex Sympathetic Dystrophy/Complex Regional Pain Syndromee, suggests thermography as the diagnostic tool for the evaluation of CRPS.

In the 24 years since I began using neuromuscular thermography in my practice, we have examined thousands of patients with neuromuscular disorders. Using electronic thermographic apparatus, the cameras (which were initially driven by liquid nitrogen) are now hi-tech computer-generated images that allow us to view the nervous system by measuring changes in skin temperature. These changes are controlled by the sympathetic nervous system and alterations in the sympathetics cause alterations in thermal (infrared) imaging which do not conform to dermatomal patterns.

While electrodiagnostic testing may show a radiculopathic pattern, such testing often errs because EMGs measure motor function as opposed to sensory function, which is the fundamental basis for CRPS. The mechanism of thermal imaging allows for perception of altered skin temperature to one-tenth of one degree centigrade. The lack of symmetry which is out of conformation to dermatomal distribution patterns goes a long way to confirming the clinical diagnosis of CRPS.

Measurements taken on an individual within approximately the first six months of the onset of the pathology will show the affected side to be warmer than the contra lateral side by temperature gradient in excess of 0.9 degrees centigrade (considered by this observer to be the standard for sympathetically mediated thermal asymmetry). Frequently this asymmetry exceeds 1.5 or 2 degrees and is clearly not the result of vascular pathology per se. After approximately six months the pattern changes with the affected side being the “cold side.” It is therefore imperative that a history of the traumatic event which precipitated CRPS be afforded the thermographic expert.

As can be seen from the images (included with this article), the temperature differential is often dramatic. While the human hand is capable of perceiving significant temperature differential between two sides, the thermal imaging camera is hundreds of times more sensitive and the temperature scale (unlike the human hand) and can be adjusted to incorporate variations in room and human body temperature, which varies from individual to individual. Additionally, this author is currently collecting data that clearly indicates that the migratory pattern of CRPS can be documented as much as six to nine months prior to the occurrence of symptomatology in a limb that has been affected with sympathetically-mediated dysfunction, but has not yet become symptomatic at the time the images were performed. It is fascinating to see patients who offer verbal complaints (in completed schematic diagram) about one limb, yet manifest thermal abnormalities in an entirely separate area. (See attached images).

In addition to the benefits in diagnosing sympathetically mediated pain syndromes, new thermographic cameras have the potential to offer real-time imaging capabilities that could allow monitoring of an affected limb during the surgical implantation of a spinal cord stimulator. By stimulating the affected nerve (thereby causing a “warming” of the damaged limb), the surgeon could place the leads accurately and “know” they were in the exact place to afford the individual the maximum benefit to be derived from such implantation. This would reduce the randomization factor currently in place by allowing for an electronic “road map” which otherwise does not exist. Similar use of thermal imaging for surgical or chemical ablations of sympathetic nerve dysfunction is possible.

In conclusion, thermographic (infrared) imaging appears to be the best, if not only diagnostic tool, that should be utilized by the clinician for objectification of a clinical diagnosis of sympathetically mediated pain syndromes. The overused adage, “A picture is worth 1000 words” is particularly applicable here, not only to assist the clinician in making the diagnosis, but to add verification to the patients’ symptoms, particularly in instances where they have been led to believe they are “crazy” because conventional diagnostic testing does not offer objective evidence of their symptom complex.

Research on thermographic imaging is on-going, bur as a diagnostic tool, much of its potential remains untapped. The number of people who have benefited from the conclusive diagnosis of CRPS by thermographic means continues to grow, thereby allowing clinicians an opportunity for earlier intervention of treatment to an affected body part.

Thermography-Musculskeletal Sympathetic Skin Response Studies

Medical Thermography For Weather-Sensitive Pain (Sympathetic Galvonic Skin Studies)

Medical Thermography for weather-sensitive pain is a sensitive, objective test that utilizes an electronic infrared imaging device to measure the body’s skin temperature (sympathetic galvonic skin response). The procedure is harmless, non-invasive, and does not use ionizing radiation.

While safeguards are built into the test to assure that the findings are both consistent and reproducible over time, there are several “Do’s and “Don’ts” for the procedure that can help minimize those things that can inappropriately impact the outcome.

Don’t sunbathe or use a tanning bed for 48 hours prior to the exam.

Do not have an EMG/ Nerve Conduction study, use a Tens unit, have physical therapy or an acupuncture treatment prior to the exam.

Do shower and keep your skin clean of any ointments or lotion prior to the exam.

Infrared Thermographic Image

Because skin temperature is controlled by the “Sympathetic” portion of the nervous system, if there is a temperature difference greater than or equal to one degree centigrade from one side of the body to the other, then there is dysfunction of the sympathetic system. Most, but not all, sympathetic dysfunction syndromes are painful. If the pain becomes progressive and severe, it is referred to as RSD (reflex sympathetic dystrophy).

While there are many disorders that can lead to altered skin temperature, thermography is really the only way to measure large regions of skin temperature while simultaneously mapping the distribution of asymmetry. In order for the procedure to be clinically useful, a physician trained in the differential diagnosis of disorders that create thermographic abnormalities must interpret it.

For example, a patient with neck and arm pain presents with abnormally persistent, weather-sensitive pain. Other studies have not helped formulate a treatment program that provides relief. A thermographic study was done and showed changes in the entire limb, tracking on the inside, medial portion of the arm and forearm. To make use of the findings, the treating doctor must know that such an abnormality can occur with a strained ligament in the wrist, thoracic outlet syndrome, or a “C” fiber mediated nerve root irritation from a cervical facet or disk in the neck.

Once the presence of abnormality is discovered, treatment emphasis may very well shift from a pain management approach alone to one that also emphasizes improved circulation and reduction of those factors that inhibit normal nerve and vascular function.

Traditionally the prognosis for the resolution of symptoms with sympathetic pain syndromes is poor. Surgical interventions often worsen the disorder, and as a result treatments have emphasized use of pharmacologic agents, physical therapy, and repeated sympathetic nerve blocks.

Due to its sensitivity and unique ability to map and record the distribution and presence of skin temperature asymmetry (sympathetic skin response), thermography has facilitated breakthroughs in the way sympathetic pain is diagnosed and treated while improving the chances for a favorable treatment outcome.

Thyroid dysfunction accounts for a huge number of metabolic problems including but not limited to weight gain or loss, fatigue, disorders of protein, carbohydrate and fat metabolism and intolerance to heat or cold.

Conventional laboratory testing is often inaccurate due to various medical conditions that can falsely elevate or depress the thyroid function studies. Ultrasonography has a value in detecting anatomic lesions. Nuclear scans and x-rays involve injection of a radioactive dye which is less than desirable to most individuals.

Thermography offers a non-invasive, non-radiologic measurement of thyroid physiology. As such it will not detect nodules or tumors but will provide a representation of physiologic dysfunction which when coupled with history, physical examination and aforementioned tests will provide a far greater picture of the thyroid function.

People with normal studies who are still experiencing symptoms will now have definitive medical evidence which will allow for a more comprehensive treatment program.

When performing thyroid thermography we look for significant temperature asymmetry between the lobes or a temperature variation between the thyroid gland and its surrounding structures. When asymmetry is present the treating physician can use this information to assist in formulating a treatment plan that will lead to normalization.

SAMPLE UPPER BODY SYMPATHETIC SKIN RESPONSE PDF

Autonomic reflex testing can be accomplished through sympathetic galvanic skin response studies. Skin galvanic impedance can be measured with infrared detectors and then mapped upon

the skin. Results are both recorded and stored in digital format.

The patient was allowed to equilibrate for 15 minutes in a temperature and draft-controlled environment prior to the study. The study was performed three times. The patient was allowed to re-equilibrate for 15 minutes prior to repeating the study each time. All studies performed were resting and under cold stress.

While galvanic impedance asymmetries correlate to skin temperature, they do not necessarily describe dermatomes, myotomes or sclerotomes. Localized pathology may represent either

peripheral nerve irritation, sympathetic dysfunction syndromes, peripheral vascular abnormalities or localized inflammatory and myofascial conditions. At least 25% of a region of interest must

be asymmetric in at least two different areas to be consistent with a thermal pattern. Clinical correlation is necessary to make this determination.

This infrared sympathetic galvanic skin response study was performed with a 640X480 camera and included evaluation of the posterior neck and shoulders, the anterior, posterior, medial and lateral arms and the palmar and dorsal aspects of the hands.

Sympathetic Skin Response Findings: There is a sympathetic skin response asymmetry pattern over the . The rest of the areas studied showed a symmetric profile. There was a symmetric sympathetic skin response present in all areas studied.

Sympathetic Skin Response Impression: Asymmetric SSR is present in a distribution. Compared to the surrounding areas localized SSR findings are present over the . This is a normal study.

Clinical Impression: Sympathetic dysfunction should be considered. The is cold compared to the contralateral side.

This would tend to r/o a sympathetically mediated pain syndrome.

SAMPLE LOWER BODY SYMPATHETIC SKIN RESPONSE

Autonomic reflex testing can be accomplished through sympathetic galvanic skin response

studies. Skin galvanic impedance can be measured with infrared detectors and then mapped upon the skin. Results are both recorded and stored in digital format.

The patient was allowed to equilibrate for 15 minutes in a temperature and draft-controlled environment prior to the study. The study was performed three times. The patient was allowed to re-equilibrate for 15 minutes prior to repeating the study each time. All studies performed were resting and under cold stress.

While galvanic impedance asymmetries correlate to skin temperature, they do not necessarily describe dermatomes, myotomes or sclerotomes. Localized pathology may represent either

peripheral nerve irritation, sympathetic dysfunction syndromes, peripheral vascular abnormalities or localized inflammatory and myofascial conditions. At least 25% of a region of interest must

be asymmetric in at least two different areas to be consistent with a thermal pattern. Clinical correlation is necessary to make this determination.

This infrared sympathetic galvanic skin response study was performed with a 640X480 camera and included evaluation of the back and buttocks, the anterior, posterior, medial and lateral aspect of the legs and feet.

Sympathetic Skin Response Findings: There is a sympathetic skin response asymmetry pattern over the . The rest of the areas studied showed a symmetric profile. There was a symmetric sympathetic skin response present in all areas studied.

Sympathetic Skin Response Impression: Asymmetric SSR is present in a distribution. Compared to the surrounding areas localized SSR findings are present over the . This is a normal

study.

Clinical Impression: Sympathetic dysfunction should be considered. The is cold compared to the contralateral side.

This would tend to r/o a sympathetically mediated pain syndrome.

SAMPLE FACIAL & PERIPHERAL SYMPATHETIC SKIN RESPONSE

Autonomic reflex testing can be accomplished through sympathetic galvanic skin response studies. Skin galvanic impedance can be measured with infrared detectors and then mapped upon

the skin. Results are both recorded and stored in digital format. 

The patient was allowed to equilibrate for 15 minutes in a temperature and draft-controlled environment prior to the study. The study was performed three times. The patient was allowed to re-equilibrate for 15 minutes prior to repeating the study each time. All studies performed were resting and under cold stress.

While galvanic impedance asymmetries correlate to skin temperature, they do not necessarily describe dermatomes, myotomes or sclerotomes. Localized pathology may represent either peripheral nerve irritation, sympathetic dysfunction syndromes, vasomotor headaches (Barre

Lieou), inflammatory sinus conditions, peripheral vascular abnormalities, and myofascial conditions. Clinical correlation is necessary to make this determination.

This infrared sympathetic galvanic skin response study was performed with a 640X480 camera and included evaluation of the anterior and lateral aspects of the face, the anterior neck strap muscles, the posterior shoulder girdle, medial aspects of the arm and forearm, and cervical

paraspinals.

This infrared sympathetic galvanic skin response study included evaluation of the anterior and lateral aspects of the face, the anterior neck strap muscles, the posterior shoulder girdle and cervical paraspinal muscles, and the medial aspect of the arms and forearms.

Sympathetic Skin Response Findings: There is a sympathetic skin response asymmetry pattern over the . The rest of the areas studied showed a symmetric profile. There was a symmetric sympathetic skin response present in all areas studied.

Sympathetic Skin Response Impression: Asymmetric SSR is present in a distribution. Compared to the surrounding areas localized SSR findings are present over the . This is a normal

study.

Clinical Impression: Sympathetic dysfunction should be considered. The is cold compared to the contralateral side.

This would tend to r/o a sympathetically mediated pain syndrome. 

SAMPLE REPORT:  INFRARED BREAST THERMOGRAPHY

Digital infrared breast thermography measures surf ace temperature and maps surf ace hypervascularity and hyperthermia. Since both of these have been associated with angiogenesis Infrared imaging can play a role in breast thermal findings assessment.

Infrared Breast Thermal Imaging is not a standalone study and should be considered adjunctive in monitoring

breast health. Results should be collaborated with other tests such as radiographic mammography, ultrasound and clinical breast exam. This study and report generation was performed in accordance with AAT Breast Guidelines.

Frontal, inferior, posterior, b il a te r a l oblique and lateral views in both color and black/white palettes were obtained. Cold stress tests are then performed. Laboratory temperature was recorded. Breast results are graded as TH1: Normal Uniform Non-vascular, TH2: Symmetrical Vascular (non-suspicious), TH3:

Equivocal, TH4: One- two factors present (moderately suspicious) TH 5: Three factors present (highly suspicious). Patients s/p lumpectomy or mastectomy are designated with an "L" or "M".

Infrared Digital Breast Mammography Findings: There is no evidence of hypervascularity or hyperthermia in

either breast on infrared breast imaging. Posterior views were normal. Cold stress study results were normal.

Conclusion: Breast findings are consistent with class: THl: Normal Uniform Non-vascular, bilat.

Clinical Impression: The role of Thermography as a Breast Thermal Findings Assessment reviewed. Follow up

with patient's primary breast health physician recommended. Annual surveillance recommended.

WHOLE BODY SCREENING THERMOGRAPHY REPORT OF FINDINGS

Name of Client: 

Date of Examination: 

ID Number:

This Thermographic Whole Body Screening Protocol is intended to be an extension of a proper physical examination. It utilizes Reference Protocol postures as approved by the Artificial

Intelligence Infrared Alliance (AIIR) as promulgated by the American Academy of Thermology (AAT). It is not to be confused with whole body examinations that are done outside of AAT Guidelines. Results are both recorded and stored in digital format.

The client was allowed to equilibrate for 15 minutes in a temperature and draft-controlled environment prior to the study such that the client was neither warm enough to induce sweating

of cold enough to induce shivering.

Thermographic findings correlate to surface skin temperature. Localized and regional call outs, asymmetries, and areas of hypervascularities (findings) may represent areas of interest. In

general variances of > 1o C are reported, however at times lesser temperature differences may be of interest. Findings do not necessarily describe or infer any aberration of physiology. Clinical

correlation is necessary to make this determination.

This Report of Findings does not constitute medical advice and is meant to be adjunctive only. Images were obtained by the thermographer with a 640X480 imager and results are to be submitted to the client by that person who is Responsible for reviewing the findings with the client.

Thermography Report of Findings: Asymmetric findings were present over the . Localized call outs include . The rest of the areas studied showed a symmetric profile. There was a symmetric sympathetic skin response present in all areas imaged.

Thermographic Impression: Asymmetric findings were present over the . Localized call outs include . There was a symmetric sympathetic skin response present in all areas imaged.

Report of Thermographic Findings Approved By:

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