Report: Breast Digital Infra-red Imaging (Thermography) and its use in Naturopathic Practice
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Report: Breast Digital Infra-red Imaging (Thermography) and its use in Naturopathic Practice The Canadian Association of Naturopathic Doctors (CAND) is the national not for profit organization representing naturopathic doctors in Canada. The CAND Report is designed to provide an understanding of the uses, safety and limitations of breast digital infra-red imaging, known most commonly as thermography, as it relates to naturopathic practice in Canada. Thermography provides an additional and unique window into the assessment of breast health and function. Like clinical breast examination (CBE), ultrasound and mammography, thermography cannot be used as a stand-alone technique to differentiate between benign and malignant breast conditions. Nor can it give information about the location and size of a tumour to guide biopsy. However, when used in combination with these other breast assessment tools, thermography has been shown to increase the sensitivity of breast cancer detection, to assist in guiding and monitoring breast cancer treatment and to provide valuable information with respect to prognosis. See Appendix A: Comparison of Breast Health Assessment Tools The main value of thermography in the field of naturopathic medicine is that it provides an early warning sign of breast health dysfunction. This early detection provides an opportunity to address early and often subtle physiological change and to improve breast tissue functionality. As well, it provides an added impetus for more attentive monitoring where indicated. The strengths of thermography are multi-faceted and make it an effective tool for naturopathic doctors to use when assessing the functionality and health status of breast tissue. Definition Thermology, more accurately referred to as digital infrared imaging (DII), is a patho-physiologic discipline that is completely non-contact and involves no form of energy or radiation imparted onto or into the body. It derives functional physiological information by measuring the temperature emanating up through tissue to the surface of the skin. These temperature readings are taken by infrared cameras that create detailed thermographic infrared images of the parts of the human body assessed. Thermography relies on the principle that all objects with a temperature above absolute zero emit electromagnetic waves. These temperature waves are emitted at wavelengths between 0.8mm and 1.0mm. Differences in “heat” waves are highlighted when a “cold challenge” is used as part of the process. The variances in “heat” waves demonstrate physiological differences in the body and provide information that can be created for visualization and quantification. History and Certification Status The first electronic infrared sensors were developed in the 1950's for military intelligence. The early medical thermologists worked in the fields of breast oncology, vascular medicine or neurology. The first non-military use started in the 1960s when the application of thermography was evaluated as a breast cancer assessment tool. What was discovered was that women with breast cancer characteristically produced thermograms showing aberrant high-energy blood vessels overlying the tumour. More recently it was established that these heat patterns are the result of hyperemia produced by the dysregulation of core body-temperature blood flowing to a relatively superficial area in the female breast. Retrospective analysis has revealed that about Report: Breast Digital Infra-red Imaging (Thermography) & use in Naturopathic Practice May 2013 1 of 11
Report: Breast Digital Infra-red Imaging (Thermography) and its use in Naturopathic Practice 90% of cancers exhibit high vascular density and hyperthermia. The technology behind digital infrared imaging has significantly advanced over the years. Current-day high-quality cameras have thousands of reference points that read heat patterns simultaneously. The technology has advanced to the point that it is possible to decipher temperature differences as little as 0.05 degrees. The medical use of infrared imaging systems has been regulated by the US Food and Drug Administration under Title 21, Parts 800-898 of the Code of Federal Regulations since 1976. There is a concern with this regulation as it 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.” Thermography is currently not regulated in Canada. Since the 1970s the advancements in technological developments in both the hardware and software for infrared imaging systems has paralleled the advancements in other areas of technology such as the computer and phone industries. While some companies have kept pace with these advances others have not. As a result the thermographic equipment currently available ranges from those with very low standards to those that truly qualify as a medical device under current legislation. The lack of standardization and variability of devices is still an area of weakness within the field of thermography as some practitioners and companies are using equipment that does not meet the standards set by The American Academy of Thermology. Since the 1980’s, Digital Infrared Thermography has evolved and its use in human health care has expanded to include: breast tissue physiology, cardiology/vascular physiology, chiropractic, dentistry, neurology, occupational medicine, orthopedics and pain management. The focus of this report is its use as it relates to breast health assessment in a naturopathic practice. As of March 2013, certification has not yet been established in Canada. The American Academy of Thermology (AAT - www.americanacademyofthermology.org) was founded in 1971 to provide independent certification at a professional level with respect to the qualifications of thermography technicians and equipment standards. Professional certified thermography / thermology includes: • Standards with respect to approved thermography equipment (temperature regulated radiometric cameras, specialized computers and specified computer programs) all certified for medical scanning under regulated conditions. • Standardized and specified preparation of the patient with exposure to regulated temperatures. • Specified regulated conditions of the clinic where the scanning is performed. • Cold-challenge to the autonomic nervous system incorporated in testing. • AAT certified technician taking the scan. • AAT certified thermologist reading the scan using the Marseilles System. • Professional reports provided to the patient’s ND or other health professional. Report: Breast Digital Infra-red Imaging (Thermography) & use in Naturopathic Practice May 2013 2 of 11
Report: Breast Digital Infra-red Imaging (Thermography) and its use in Naturopathic Practice Methodology To provide a useful, reliable and repeatable evaluation of breast health, stringent standards for patient preparation, scanning and reading of the scans must be adhered to. The reliability of any thermography report depends on three criteria: the quality and type of camera used, the process used for the thermographic screening including whether or not a cold challenge is included, and the standards used to interpret the results. 1. Camera Selection The camera or infrared imaging system that is used determines the specificity and the information that is acquired. Generally speaking, cameras fall into two categories: thermal imagers and radiometric infrared cameras. • Thermal imagers typically produce a non-calibrated (non-quantified) analog or digital output signal based upon the level of infrared energy emitted by the body. This type of camera is limited in functionality and is significantly less costly. It is only valuable as a speculative tool in qualitative applications. Thermal imagers are often unreliable between calibrations due to the temperature variations (thermal drift) that occur on an ongoing basis. Another concern is that temperature readings are made based on comparing the energy emitted from the body to an external thermal image versus assessing temperature differences within the body itself. There are no standards for interpreting the results from thermal imagers. For the above reasons, thermal imagers are not recommended as part of a naturopathic breast health assessment. • Radiometric infrared cameras operate in a manner that is significantly different from thermal imagers. Radiometric 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. Because radiometric infrared cameras also provide for thermal drift compensation, 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 imaging cameras). Therefore, radiometric infrared cameras are the instrument of choice as they produce quantified 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 measured. Additionally, results from radiometric infrared cameras can be read using the standardized Marseille system to grade the thermology reading. 2. Thermography Process There is a standardized process that all certified thermologists must follow in order to ensure the accuracy of their results and to ensure that individual limitations are appropriately considered. Report: Breast Digital Infra-red Imaging (Thermography) & use in Naturopathic Practice May 2013 3 of 11
Report: Breast Digital Infra-red Imaging (Thermography) and its use in Naturopathic Practice For clarification of the process refer to the American Academy of Thermology (www.americanacademyofthermology.org). Key aspects of the process include: • Images taken. Professional digital infrared breast thermography scans need to be carried out by a certified technician. The images taken include two bilateral and one frontal shot, then a cold-challenge for one minute followed by taking the same three images post challenge, all under regulated conditions, i.e. room temperature 21°C etc. • Cold Challenge. A cold-challenge refers to the immersion of the hands into cool water (11°C) for 1 minute between the two sets of images. This “cold water challenge” has been demonstrated as a powerful component of the quantitative and objective analysis of breast thermography. Please note: A premise of thermology is that the heat signature of the breasts’ blood vessels reduces normally when an autonomic nervous system challenge is evoked by a cold challenge. Normal blood vessels contain smooth muscles controlled by the autonomic nervous system. Before a malignant tumour forms, there are early changes in the regional blood vessels caused by the nitric oxide production of dysplastic cells. This results in vasodilation that is resistant to normal regulation by the autonomic nervous system. As tumours reach a certain size (perhaps as small as 3mm or 1/8”) and need more nutrient-carrying blood to keep growing, they initiate development of neoangiogenic blood vessels which remain hot as they do not respond to commands from the nervous system to cool. The cold challenge used in thermography assesses whether or not the breast is cooling down normally. Thermography results may also indicate dysregulation in normal blood vessels due to other factors such as fibrocystic breast issues or other possible patho-physiologic changes. 3. Interpretation Standards The pre and post scans are analyzed by certified thermologists using an established system. Currently the Marseilles System, which has been used internationally since 1975, is the only established objective system for interpreting results acquired from radiometric infrared cameras. This system provides for a TH-1 – TH-5 scale as a summary based upon specific, objective and quantitative thermal features and differential levels of infrared energy. See Appendix B for details of the Marseille Rating System. Scans are also compared to a patient’s previous scans to assess the progress of breast health or dysfunction and a standardized report is provided. Report: Breast Digital Infra-red Imaging (Thermography) & use in Naturopathic Practice May 2013 4 of 11
Report: Breast Digital Infra-red Imaging (Thermography) and its use in Naturopathic Practice Strengths and Limitations of Thermography Strengths The main value of thermography is that it provides an early warning sign of breast tissue dysfunction and subtle physiological changes in breast health, signalling an added impetus for more attentive monitoring and remedial naturopathic treatment programs. Thermography is not affected by age and hence may provide an advantage over other assessment tools for younger women (under the age of 50 years). Mammography, for example, has low specificity and is not recommended for women under the age of 50. Thermography can be used with men and for those with dense or fibrotic breast tissue as it is not influenced by tissue density or breast size and shape. For younger individuals (those in their 20s and 30s) where there is a concern about breast tissue function, thermography is a safe assessment tool for watching breast tissue changes without repeated radiation exposure. Thermography may detect signs of neoangiogenic vessels that feed small cancers and of faster growing, more aggressive cancers at an earlier stage than other detection modalities. Thermography may detect tumours with a high growth rate and hence it has been proposed that thermography may have a role to play with respect to health risk and prognosis. Thermography has been shown to enhance the ability of other breast cancer detection modalities, which rely on anatomical changes. Combining clinical exam and thermography with mammography and/or ultrasound can increase accuracy of the findings. Thermography is beneficial in the detection of breast tissue changes or dysfunction such as benign breast lesions, including abscess, adenosis, cysts, duct stasis, fat necrosis, fibroadenomas, fibrocystic breast disease and inflammatory breast conditions. Limitations Inconsistency in methodology between various styles of cameras, differences in processes followed (cold challenge versus non-cold challenge) and a vast range of standards with respect to interpretation have led to variations in research results and in individual studies. The high-rate of false-positive results continues to be the greatest criticism of thermography. Yet, follow-up studies indicate that it can take up to 10 years for other diagnostic tools, such as mammograms, to confirm a diagnosis of breast cancer that initially showed up as an abnormal thermoscan. Thermography does not distinguish between cysts and benign or malignant tumours. It differentiates between normal physiologic breast tissue and diseased tissue. Thermography does not provide location or indicate depth or size of tumour. Tumours without active angiogenesis, i.e., “cold” tumours, are not detectible by thermography. Report: Breast Digital Infra-red Imaging (Thermography) & use in Naturopathic Practice May 2013 5 of 11
Report: Breast Digital Infra-red Imaging (Thermography) and its use in Naturopathic Practice Larger, multi centre studies and meta-analyses specifically looking at thermography would assist in guiding clinicians on how best to use thermography in practice. The variation in equipment standards and in tight government regulations continues to hamper thermography. Recommended Uses for Breast Thermography in Naturopathic Practice The main value of thermography is that it may provide an early warning sign of subtle physiological changes to breast tissue, thus providing an added impetus for more attentive monitoring and remedial naturopathic treatments. Thermography may be an effective tool for assessing functional changes in breast tissue and monitoring progression or regression of such changes as well as evaluating tissue status post biopsy, post lumpectomy and post mastectomy. Thermography is a safe, adjunctive assessment tool that can be used along with CBE, ultrasound and mammography in the monitoring of breast health. Thermography can be a useful tool during cancer treatments as the presence or absence of hypervascularity and hyperthermia directly relates to the success of chemotherapy and the prediction of survival rates. Thermography may be a valuable tool for predicting several different types/stages of cancer, such as DCIS, medullary carcinoma and infiltrating ductal carcinoma. Appendices Appendix A – Comparison of Breast Health Assessment Tools Appendix B – Marseille Rating System Thermography Task Force Dr. Iva Lloyd, ND Dr. Verna Hunt, ND ** Dr. Patricia Wales, ND Dr. Nicole Daniels, ND ** Disclosure: Dr. Hunt was the co- founder and owner of Medical Thermography International (MTI) between 2001 and 2004. Since that date she has been working with MTI as their naturopathic medical advisor. Report: Breast Digital Infra-red Imaging (Thermography) & use in Naturopathic Practice May 2013 6 of 11
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Report: Breast Digital Infra-red Imaging (Thermography) and its use in Naturopathic Practice 47. Martin JHJ, Begum S, Alalami O, Harrison A, Scott KWM. Endothelial nitric oxide synthase: correlation with histologic grade, lymph node status and estrogen receptor expression in human breast cancer. Tumor Biol. 2000;21:90-97. 48. Negri S, Bonetti F, Capitanio A, Bonzanini M. Preoperative diagnostic accuracy of fine-needle aspiration in the management of breast lesions: comparison of specificity and sensitivity with clinical examination, mammography, echography, and thermography in 249 patients. Diagnostic Cytopathology. 1994;11(1):4-8. 49. Ng EY, Ung LN, Ng FC, Sim LS. Statistical analysis of healthy and malignant breast thermography. Journal of Medical Engineering & Technology. 2001;25(6):253-263. 50. Ng EY, Sudharsan NM. Computer simulation in conjunction with medical thermography as an adjunct tool for early detection of breast cancer. BMC Cancer. 2004;4:17. 51. Parisky YR, Sardi A, Hamm R, Hughes K, Esserman L, Rust S, Callahan K. Efficacy of computerized infrared imaging analysis to evaluate mammographically suspicious lesions. AJR. 2003;180(1):263-269. 52. Parisky YR, Skinner KA, Cothren R, DeWittey RL, Birbeck JS, Conti PS, Rich JK, Dougherty WR. Computerized thermal breast imaging revisited: an adjunctive tool to mammography. In Engineering in Medicine and Biology Society. (1998) Proceedings of the 20th Annual International Conference of the IEEE. 53. Reveneau G, Arnould L, Jolimoy G, Hilpert S, JeJeune P, Saint-Giorgio V, Belichard C, Jeannin J.F. Nitric oxide synthase in human breast cancer is associated with tumor grade, proliferation rate, and expression of progesterone receptors. Laboratory Investigation. 1999;79(10):1215-1225. (abstract) 54. Spitalier JM, Clerc S, Levraud J, Pollet JF, Medina M, Amalric R, Fondarai J, Thermography and future of operable breast cancers. Acta Thermographica. 1978;3:100–106. 55. Spitalier JM, Brandone H, Duarte J, El-Ghazawy IMH, Amalric R, Giraud D, Altschuler C, Magami P, Kurtz JM. The Importance of Infrared Thermography in the Early Suspicion and Detection of Minimal Breast Cancer, in Thermal Assessment of Breast Health (Proceedings of an International Conference). MTP Press Ltd. 1983, 173-179. 56. Stark A. The value of risk factors in screening for breast cancer. European Journal of Surgical Oncology. 1985;11(2):147-150. (abstract) 57. Stark AM, Way S. The use of thermovision in the detection of early breast cancer. Cancer. 1974;33(6):1664-70. 58. Sterns EE, Curtis AC, Miller S, Hancock JR. Thermography in breast diagnosis. Cancer. 1982;50(2):323-325. 59. Sterns EE, Zee B, SenGupta S, Saunders FW. Thermography. Its relation to pathologic characteristics, vascularity, proliferation rate, and survival of patients with invasive ductal carcinoma of the breast. Cancer. 1996;77(7):1324-1328. Report: Breast Digital Infra-red Imaging (Thermography) & use in Naturopathic Practice May 2013 10 of 11
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Report: Breast Digital Infra-red Imaging (Thermography) and its use in Naturopathic Practice Appendix A: Comparison of Breast Health Assessment Tools The following Table outlines the pros and cons of the main breast health assessment tools. Testing Methods Uses Pros Cons Self Breast Exam Monitor breast tissue changes Consistent monthly monitoring Women who do not know what (SBE) individually. helps women be familiar with they are looking for can evoke their breasts and changes that anxiety. 1 occur routinely. Clinical Breast Exam Recommended every three years Low cost, easily repeatable, part of Only effective after a lesion has (CBE) for women 18 – 39 years old, and annual physical medical exam. grown large enough to be every year for women 40 and old. 2 palpable. No standardized method of Sensitivity: ~40 to 70% 2 charting findings. Specificity: ~85 – 95%2 Digital Infra-red Uses infrared sensors to detect heat No radiation. No contact. Non- Does not differentiate between Imaging and increased vascularity invasive, low cost, easily & safely benign and malignant (Thermography) (angiogenesis). repeatable. conditions. 9 Sensitivity: ~80 to 85% 3 Not influenced by tissue density, Cannot provide specific location breast size and shape, age, breast 9 Specificity: ~65% to 80%3 or size of a tumor. implants. Can identify lesions of all sizes. 4 High false positive rate (caveat: may be an early warning sign). 10 Early warning sign. Indicates functional changes in breast tissue Cold and slow growing tumors before other methods detect may be missed. 11 pathology. 5 Ability to detect fast-growing, aggressive tumours. 6 May provide an indicator of high risk patients, tumor growth rate, prognosis, survival rate and probable success of chemotherapy. 7 Enhances other breast cancer detection modalities. 8 Ultrasound High frequency sound waves are No radiation, non-invasive, Limited use as stand-alone test. bounced off the breast tissue and harmless. collected as an echo to produce an image. Provides information on the location and size of an 12 Sensitivity: ~80 – 85% 12 abnormality. Specificity: ~65%12 Good at distinguishing solid 12 masses from fluid-filled cysts. Mammograms Passes radiation through the breast Structural imaging with ability to In most women, the medial to produce an image. locate the area of suspicious tissue upper triangle, areas next to the chest wall, and the infra- Recommended every two years, for Can detect tumors in the pre- mammary sulcus cannot be women aged 50 to 74. invasive stage of mainly slow- 12 visualized with accuracy.
Report: Breast Digital Infra-red Imaging (Thermography) and its use in Naturopathic Practice Appendix A: Comparison of Breast Health Assessment Tools 12 growing cancers. Cannot detect exponentially 12 fast-growing tumors in the pre- Sensitivity: 60-96% 12 ~80% in women over age 50. invasive stage. ~60% in women under age 50. 12 Sensitivity is lower in women Specificity: ~66 - 75% ~80% of all mammogram under 40 years of age and in initiated biopsies are negative. those with large, dense or 12 fibrocystic breasts. High false-positive rate ranging 12 from 20 to 56%. Concern that repeated mammograms may increase risk of breast cancer due to repeated 12 radiation exposure. There are a wide range of factors that impact functional and structural changes including age, menstruation, pregnancy, lactation, menopause, breast tissue density, oral contraceptives, hormone replacement therapies, other hormonal treatments, breast implants, previous biopsies, breast tissue density, concurrent health concerns, inflammation and infection, type of breast pathology both benign and malignant, as well as provider evaluation and follow-up practices. The best breast assessment tool is dependent on the factors above and on the strengths and limitations of each technique or tool as no one tool is 100% effective at screening for breast cancer or other breast health conditions on its own. In fact, a biopsy is the only test that can determine if a suspected tissue area is cancerous – all other methods can only identify suspicious areas. The goal of screening should be to use the assessment method(s) most likely to afford accurate early detection and therefore long-term protection against development of a disease. Sources Medical Thermography Intl. Inc. Mammography / Thermography / US. What different information is obtained. Accessed March 2013 www.medthermonline.com. References 1 Humphrey (2002) 2 Davey (1970) 3 Hoekstra (2013) 4 Wishart (2010), Keyserlingk (1998), Spitalier (1983), Stark (1974), Dodd (1969) 5 Gamagami (1997), Stark (1985), Amalric (1982), Spitalier (1983), Sterns (1982), Gautherie (1980), Stark (1974) 6 Isard (1988), Gaitherie (1980) 7 Ohsumi (2002), Sterns (1996), Head (1993) 8 Parisky (2003), Ohsumi (2002), Almaric (1982), Spitalier (1978), Jones (1975), Isard (1972), Dodd (1969) 9 Hoekstra (2013), Gamagami (1997)
Report: Breast Digital Infra-red Imaging (Thermography) and its use in Naturopathic Practice Appendix A: Comparison of Breast Health Assessment Tools 10 Sterns (1996), Amalric (1982), Spitalier (1978), Stark (1974), Dodd (1969) 11 Ohsumi (2002), Sterns (1996), Isard (1988), Almaric (1982), Jones (1975) 12 Jackson (2009), Humphrey (2002), Kolb (2002), Keyserlingk (1998), Kerlikowske (1996)
Report: Breast Digital Infra-red Imaging (Thermography) and its use in Naturopathic Practice Appendix B: Thermography Marseille Rating System Rating Th-1 Th-2 Th-3 Th-4 Th-5 Atypical metabolic or Positive thermogram with Very high probability of Description Normal Functional changes significant risk for malignant disease vascular process malignant disease Risk for malignancy No risk No risk Minor or equivocal risk Significant risk Very high risk < 10- 20 % 65 – 85 % Approx. 96 % Features No thermology signs Even, non-complex, Uneven or unusual Two or more positive Two or more thermology associated with disease moderately hyperthermic circulatory patterns thermology signs or a single criteria vascular-like features involving most of one breast thermology criteria. Indicates benign changes OR defined circulatory e.g. hormone imbalances pattern that does not cool *Need for follow up testing *Need for follow up testing affecting breast tissue down from cold challenge. to address possible to address possible Indicates benign changes malignant activity. malignant activity. e.g. inflammation, acute cysts &/or fibro-adenomas, infection or personal variant Modified Rating Th-1F Th-2F Th-3L or Th-3M Th-4L or Th-4M Th-5L or Th-5M Features Some distinctly Distinct hypothermic Note: The L refers to a hypothermic patterns patterns previous lumpectomy; the M to a previous mastectomy. Indicates Normal breast tissue Normal breast tissue Sustained heat at site Sustained heat at site & no Sustained heat at site & no response. response. response to cooling challenge response to cooling challenge Correlates to Symptoms of hormone Symptoms of hormone Surgery, radiation or Possibly indicates malignant Probable malignant disease. changes, such as pre- changes, such as pre- chemotherapy (all produce disease. Follow-up with Follow-up with other menstrual tenderness, lumpy menstrual tenderness, lumpy significant tissue other diagnostic testing diagnostic testing texture or excessive feeling texture or excessive feeling inflammation, edema, recommended. recommended. of heaviness in breast tissue. of heaviness in breast tissue. abnormal tissue metabolism, nerve damage and regrowth of circulatory vessels). Medical Examination Possible referral for targeted Referral for targeted Immediate referral for ultrasound and , if ultrasound &/or medical examination, indicated, mammography mammography ultrasound, mammography and possibly biopsy Thermography Follow-up If objective evaluation does 1 year 1 year 90 – 120 days 60 – 90 days not demonstrate malignant breast disease, recommend repeat thermography in 60- 90 days Reference: Amalric R, Giraud D, Altschuler C, Spitalier JM. Value and interest of dynamic telethermography in detection of breast cancer. Acta Thermographica 1976;1(2):89-97.
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