Report: Breast Digital Infra-red Imaging (Thermography) and its use in Naturopathic Practice

 
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

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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.

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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.

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Report: Breast Digital Infra-red Imaging
                                                 (Thermography) and its use in
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    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.

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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.

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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.

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Report: Breast Digital Infra-red Imaging
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   66. US Food and Drug Administration. Code of Federal Regulations: Medical Devices Amendment to the
       Federal Food, Drug and Cosmetic Act. (1976) Title 21, Parts 800-898.

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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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