Women Have A Safe Alternative to Mammograms to Maintain Annual Screenings

For immediate release from the American College of Clinical Thermology.

 Women of all ages received good news with the recent revision of the government recommendations for screening mammography.  The US Department of Health and Human Services released their findings and recommendations that screening mammography should now be started at age 50 and performed bi-annually. Up until now, screening was recommended on an annual basis at age 40; this new recommendation has created renewed controversy as doctors have concerns about reducing the number of mammograms that would be clinically justified and indicated..  It takes years for most cancers to develop to the stage that they can be detected with mammogram or ultrasound (dense enough for location and biopsy) so Breast Thermography or Digital Infrared Thermal Imaging (DITI) is ideally placed as an alternative screening tool to identify changes over time in the ‘early’ development stages, before there is more advanced pathology that can be detected with other tests. If changes for the better are to be made, then the recent recommendations of the Preventative Services Task Force will establish the foundation of a more affective screening program which should integrate other types of safe testing.  Of the various testing options Breast Thermography or Digital Infrared Thermal Imaging (DITI) offers the most promise for screening the younger age group women.  

To understand the arguments and issues involved with the new recommendations, we need to understand the difference between ‘screening mammography’ and ‘diagnostic mammography’:

‘Screening’ mammography has been performed annually on healthy women from the ages of 40 to 70 and is aimed at identifying suspicious findings, which justify further investigation. ‘Diagnostic’ mammography is performed on patients who have one or more risk factors, clinical symptoms, or most commonly a palpable lump. There is little argument about mammography’s role as the ‘gold standard’ for

evaluating suspicious symptoms but the question was, can we still justify subjecting women without symptoms to ‘screening’ mammography ?  The answer was NO.

The federal department of health and human services  task force says that “the modest benefit of screening mammograms must be weighed against the harms… which are nearly cut in half when mammograms are performed every other year  but the benefits remain the same”. It needs to be pointed out that the recommendations of the task force are not intended for women at increased risk for breast cancer who should continue to be referred for diagnostic mammography by their doctors when appropriate, and on a case by case basis. It is interesting to note that The United States is currently the only country that routinely screens women below age 50 and extends its screening practice by taking two or more mammograms per breast annually in women over age 50. This contrasts with the more restrained European practice of a single view every two to three years. The evidence concludes that while there is a justifiable role for mammography to play in a breast cancer screening program that role is very different from the one currently in place.

For over 20 years Breast Thermography is being used increasingly  by women throughout the US, and it has been rapidly gaining acceptance by doctors as an additional tool in the early diagnosis of breast disease. FDA registered since 1984, Thermography is an adjunctive diagnosic test being offered by hundreds of clinics in all states. A list of certified thermography clinics can be found at the The American College of Clinical Thermology website at :   http://www.thermologyonline.org/Breast/breast_thermography_clinics.htm. Thermography is 100% safe, has no radiation, does not touch the breast, and only takes a couple of minutes. A positive or suspicious thermal study will indicate medical necessity for a mammogram, ultrasound or other tests. The thermal findings will increase the sensitivity and specificity of most other tests by targeting an area of the breast showing dysfunction and providing decision making information in women that would not have otherwise been tested.

Early detection is aimed at prevention and if early changes are detected then we have an opportunity to intervene and change the outcome. The earlier an abnormality is detected the better the treatment options will be, resulting in a better outcome. There are no contraindications for DITI, it is totally non-invasive, no radiation of any type, and no contact with the body so it can ‘do no harm’. DITI is positioned as the ideal screening test for women of all ages but particularly for the 30 to 50 age group. The best possible plan is to use every appropriate test adjunctively to get the highest detection rates without generating additional or unnecessary invasive testing. It would be unfortunate for a patient to forgo a necessary mammogram that was justified, and any decision should be made between the patient and her doctors based on individual history, symptoms and test results.

The principle of informed consent in medicine is ignored if women are not informed of the evidence relating to any risks of a test and if women more readily consent to annual mammograms because they have been given ‘misinformation’ this is as bad as obtaining consent by deliberately blocking valid information. Women are entitled to know the full range of responsible opinion about the benefits, the risks, and the many uncertainties of mammography.

The government task force are to be applauded for presenting the evidence for women and their doctors to be able to make better informed decisions about breast screening.

As reported, the scientific and medical evidence indicates that:

No ‘screening’ mammography is justified for women under the age of 50.

A baseline screening mammogram may be justified at age 50 and bi-annually thereafter.

Accountability and responsibility should be considered in regard to all radiation exposure and the accumulative biological effects.

Reducing ionizing radiation exposure from all other sources whenever possible should be practiced.

Up-to-Date and accurate information must be given to patients for informed consent.

Other non invasive tests should be promoted as part of a breast screening program.

Thermography, Ultrasound and MRI should be further explored, adapted and integrated.

With the pre mammogram age group (under 50) the benefits of screening to detect any findings or changes that justify additional testing or closer monitoring are simple. With any positive DITI findings in this younger age group, any mammogram and ultrasound sensitivity and specificity will be increased with the objective DITI findings targeting a dysfunction and location and providing decision making information in women that would not have otherwise been tested.

It takes years for most cancers to develop to the stage that they can be detected with mammogram or ultrasound (dense enough for location and biopsy) so DITI is ideally placed as a screening tool to identify changes over time in the ‘early’ development stages, before there is more advanced pathology that can be detected with other tests.

The major benefit in this group is in detecting early changes that precede malignant pathology that will become diagnosable at some stage.

Early detection is aimed at prevention and if early changes are detected then we have an opportunity to intervene and change the outcome.

The earlier an abnormality is detected the better the treatment options will be, resulting in a better outcome.

Prevention may include treatment of inflammation, fibrocystic disease, lymph congestion, estrogen dominance and more specific conditions like angiogenesis.

DITI does not provide any of the same findings or information that mammogram or ultrasound provides, it is a different type of test. DITI shows information relating to vascular activity, inflammation, lymphatic activity, hormonal dysfunction and other ‘functional’ abnormalities. 

There are no contraindications for DITI, it is totally non-invasive, no radiation of any type, no contact with the body so it can ‘do no harm’.

Mammogram and ultrasound shows ’structure’, tissue densities can be evaluated, lumps can be measured, calcifications located and opinions given regarding pathology before biopsy ….. none of which DITI can provide.

There is no comparison or competition between mammogram and DITI. They are two different tests providing different results !    

The results are reported by medical doctors who are certified thermologists and experienced in reading thermograms, the reading doctor takes into consideration all history and symptoms and the results of other tests.

In patients of mammographic age (generally over 50), post menopause or when the density of breast tissue has reduced sufficiently to make mammography more affective, DITI not only provides the benefit of early detection of functional change but can also increase the detection rates of other tests by contributing additional information about functional (physiological) abnormality and also the location of suspicious (positive) thermal findings that may be outside the range of other tests due to location, size of breast, implant, or other limiting factors .

DITI as a screening test in all age groups is designed to establish a baseline (the patients normal thermal fingerprint) for ongoing comparative analysis (normally annual) to detect any physiological change that justifies additional testing (which could be physician exam, mammogram, ultrasound, MRI, blood work, hormone testing or a number of other interventions).

The changes that DITI can detect include, inflammatory pathology (inflammatory carcinoma / inflammatory breast disease) Infection, Lymph dysfunction (lymph congestion, lymph node pathology) Vascular changes (development of new and abnormal blood vessels known as ‘angiogenesis’) and also any suspicious activity outside the range or scope of other tests (outside the boarder of the breast, in the sternum or axilla) so again, there is no comparison or competition between different tests.

DITI cannot detect specific pathology like a biopsy, it cannot detect tumors or micro-calcifications. DITI cannot ‘see’ structure.

DITI does have the potential to create anxiety for a patient (as does mammogram) with equivocal results or results that cannot be confirmed or positively diagnosed but both tests can minimize unnecessary anxiety with better informed consent, education and realistic expectation for the test.

The best possible plan is to use every appropriate test adjunctively to get the highest detection rates without generating additional or unnecessary invasive testing.

It would be unfortunate for a patient to forgo a necessary mammogram that was justified, and any decision should be made with consultation between the patient and her doctors based on individual history, symptoms and test results. 

Peter Leando PhD. DSc. DAc..

Fellow, Royal Society of Medicine.

Fellow, American College of Clinical Thermology.

2030 West First St., Suite E

Fort Myers. FL. 33901

Office: 1-239-337-3631

Fax: 1-239-337-3632

Cold stress testing of the breast was performed on the assumption that thermography would identify angiogenesis and that angiogenesis could be correlated with the development and existence of breast cancer. This can be possible if a number of factors are present but there are too many variables that we now know make this an unreliable procedure. We don’t know at what stage angiogenisis begins but we do know that it does not continue throughout all stages of breast disease. No studies have been done to find out how long it takes for new (angiogenic) blood vessels to establish sympathetic fibers which then let the vessel behave like a normal vessel (contract when cold stressed) but even if we did have a better understanding of this physiology it would still not be a reliable test as many patients would undoubtedly fall outside of the window of detectable angiogenesis.

Considerations, the logic and philosophy of performing a cold stress test:
1. If there are no suspicious thermal patterns to test, (negative thermogram) the test is not justified.
2. If there are suspicious patterns (positive thermogram) then the patterns remain suspicious irrespective of the results of cold stress testing……. A cold stress test does not and should not affect the thermographic opinion and resulting report.

3. A cold stress test might offer results relating to a particular suspicious pattern but if there is no way of correlating this information to a clinically valid or plausible rational to act on this information then the test is not justified in the first place.
4. If a cold stress test is performed and the results are reported, this changes the status of the test and the report, both of which make claim to diagnostics and will carry the associated increase of liability and issues of scope of practice and medical licensure (practicing medicine without a license).
5. The disservice to patients who suffer unnecessary mammography, biopsy, and other tests as a result of positive thermography generated by the attempt to produce diagnostic results from a single study is unacceptable.
7. Reporting vascular change over extended periods of time by comparative analysis of thermal testing may be enhanced by the inclusion of a cold stress test if ordered specifically by a licensed physician who can integrate the results into decision making or a differential diagnosis. Historically, it was the way breast thermography was used with protocols that included cold stress testing (and the diagnostic claims that were made) which generated the criticism that thermographers still suffer from today. The accusations of unreliability and the clinical trial results showing false positives and false negatives were all generated by the protocols that included cold stress testing. Cold stress is a test of sympathetic function which has good utility in many areas of medicine and is the definitive diagnostic test for CRPS / RSD. These tests were used before it was tried in breast screening.

In the mid eighties many people, including myself got excited by the potential offered by breast thermography performed with cold stressing. I was lucky enough to be working in France where the concept originated and I did a lot of cold stress thermography with a liquid nitrogen cooled NEC Sani and a Hues Aircraft Probeye, both of which were excellent cameras at the time. My own observations regarding the low rates of correlation between the results of cold stress tests and case histories and the growing evidence of false positives and false negatives led me to abandon cold stressing of breasts in the early nineties. I learned a more logical and more efficient approach which still relied on the detection of changes in the breast over time but was far more objective and reliable.

We have advanced significantly in our understanding of physiology and how thermography can be effectively used. No technology stands still, we expect science to advance, medical knowledge to improve and evolve and we have to be prepared to learn from experience….. both our own and others. I have no doubt that there will be ongoing advances in thermographic imaging and they may even include new forms of stress testing but the best way to move forward is to learn from experience and then look ahead rather than back.

First published August 2003 ACCT Thermology Times.

————————————————————————————-

Thermal Image Analysis    
                                                                 Dr. William Cockburn, DC, FIACT, FABFE
                                                                                Fellow in Thermal Imaging

Announcement of Official Change in Thermal Reporting
Effective Date:  July 26, 2005

————————————————————————————-

There has been much controversy within the thermal imaging community, and much comment by outside observers concerning two factors related to the interpretation of thermal imaging of the human breast.   In this regard, I have spent quite some time investigating alternative language and reporting methodology and I have determined to make changes to my interpretation reports as follows:

1)  The Thermal Rating System is being dropped.

The thermal rating system has proven to be a hindrance to proper communication and understanding of actual findings with referring physicians and indeed, with patients.  The rating system has not been updated nor revised since its initial inception and utilization in the mid 1980’s.   There are two significant problems which routinely occur with the utilization of the reporting system; however there has not been a proposed change that makes good clinical sense until now.  The two key problems with the thermal reporting or thermal rating system are:

    A)  Unresolved anxiety for both patient and physician when TH3 – TH5 class thermograms are not confirmed by so-called conventional methodologies such as Mammography, Ultrasound or MRI.  We all know that a positive thermogram is often many years ahead of anatomical testing as confirmed by the scientific research, but this does not help us when we “label” a breast as suspicious and no other method can confirm or deny the thermal findings.   This creates the medical impression of a false positive and the resulting loss of confidence by the referring clinician.

    B)  Inaccuracy of the Rating System itself.   This rating system was designed decades ago to provide for a more accurate and quantifiable system of reporting risk, however it has inherent errors which I feel cause tremendous confusion for the primary care physician and indeed the patient.  Many patients with cancer have only one rating factor, for example a marginal 1.1C delta at the nipple, and are as such, rated TH-3 Equivocal.   Other patients may have three or more low level rating factors with a completely healthy breast and as such are rated TH5 Suspicious.  Often these patients present in my practice for many years with absolutely no change in thermal patterning,  In other words – no increase in vascular or heat signature.  Very often these patients have anatomical testing which is clearly within the normal parameters (not equivocal).

In the world of diagnostic imaging, the premise of any system, be it mammography, ultrasound or thermography is simply to identify risk factors which may not be determined in any other way.   As such, a heads up is given to the primary care doctor that there may be pathology requiring further investigation.   That is all.  

The attempt of earlier thermographers to create a rating system which is more objective and meaningful has actually created confusion within and outside of the thermal imaging community, and as such, this system should be abandoned.

This does not mean however, that reporting should simply be a series of circles or squares drawn over areas of clinical concern.   Some rating factors, especially those in the “primary factors” category, still require description as a methodology to alert the primary care physician to areas of higher concern.  To label these patients as equivocal, abnormal, suspicious or for that matter, normal is an inappropriate reporting methodology and as such, is no longer to be utilized.

2.   The use of the Thermal Cold Stress Challenge for Breast Evaluations is being dropped.

This protocol has never been scientifically proven to be reliable and may indeed; affect the clinical management of a patient in the wrong way, for the wrong reason.

There are several solid reasons for this decision and these factors are related to my 20 years of clinical practice in the realm of thermal imaging.  I wish to share these factors with you as a practicum.

    A)  There is no reliable literature nor blinded study to validate the use of the procedure for breast thermal imaging studies, contradictory to many studies on Reflex Sympathetic Dystrophy (RSD) and Chronic Regional Pain Syndrome (CRPS) (CMPS)  Many thermographers have inappropriately applied the cold stress challenge designed for neurological conditions to the female breast. 

    B)   The use of the stress challenge does not, and should not be used as an indicator of “aggressiveness” or “staging” of breast cancer.   Some interp clinicians actually utilize a (+) or (-) in their reporting methodology to indicate whether for example, a Suspicious breast (TH5) is more (+) or less (-) suspicious depending on whether or not the area cooled.  This is not a verifiable protocol and it is to be discouraged.  (TH5+ or TH5-)  An abnormal breast factor is ratable as a factor and requires clinical correlation, period.

    C)  The degree of cooling, or lack thereof, has also not been scientifically established as an indicator and I feel this has been an anecdotal use of the procedure. As such the stress challenge can be very misleading to both physician and patient.  Depending on dietary influences, hormonal levels of the particular day, and the amount of stress within the patient from a variety of sources, the stress challenge may be more or less effective.   Some days, a patient will cool 0.2C in a given area, and six months later 1.0 and on the next visit, 1.5.  Some patients will not cool on a particular visit even 0.1C and on a subsequent visit they may cool 1.2C.   Of course there are many instances of patient’s temperature increasing on the stress challenge and then on subsequent visits the area cools or stays the same.   These variances have cast great doubt on the reliability of the stress challenge.

    D)  Some anatomical factors which are benign can severely compromise the ability of the sympathetics to provoke vasoconstriction.   This would include blood vessels which have been compromised by surgery, incisional biopsy, lumpectomy, local trauma and even thoracic spine instabilities.  These factors can provide for permanently dilated vessels or capillary networks which fail to respond to sympathetic stimuli.

    E)  The patient’s own apprehension of the procedure may produce sympathetic fight or flight responses prior to the stress challenge, often seen when patients can view the monitor during exam for example.  This provokes a cooling response and “sets” the sympathetic tone prior to the actual cold challenge thus producing potential failure reporting when the fight or flight response actually took place minutes or moments before.  Other examples of this are fear of the exam, an event proximate to the exam that has upset the patient (phone call) (rude comment) (slip and fall) etc.  Many of these variables simply can not be accounted for.

    F)  Finally, and most simply, the fight or flight sympathetic response has never changed the thermal rating nor denies the need for further testing and correlation.   Some clinicians will make a decision on whether or not to order additional testing based on the Success or Failure of the stress challenge procedure.   The very fact that we can not with thermography, determine the amount or aggressiveness of angiogenesis validates this fact.   The question must be asked-  At what point of existing cancer development does angio-neo-genesis override sympathetic input?  It is a great concept in theory, but it is not practical in day to day practice.

These factors (the thermal rating system) and (the cold stress challenge) contribute greatly to an overall confusion of the basic purpose of breast thermography and are based largely in Dogma.  The purpose of breast thermal imaging is to view with a complimentary technology, the human breast and to determine if there are areas of clinical interest that require further clarification that can not be seen by other methods. 

Thermography is a screening procedure.  To continue to follow dogma and unproven methods will further restrain and constrain the advancement of this noble science.

William Cockburn, DC, FIACT, FABFE
Fellow International Academy of Clinical Thermology
Fellow American Board of Forensic Examiners

Thermographic screening at airports and any other locations where the public congregate or travel is targeting individuals who are already symptomatic and likely to be infectious, (coughing, sneezing and the production of mucus causing the fastest spread).

The highest risk for the geographic spread of infection is through travel and ’seeding’. Thermographically screening travelers has a multi level benefit.

1. Sensitive screening to detect abnormal physiology (hot or cold) will detect a high % of abnormal (which can then be individually evaluated and further tested if necessary)  This group will fall into the symptomatic category who will be best detected with a ‘mass’ screening approach (rapid movement through airports etc).

2. Sensitive and targeted screening to detect sub-clinical individuals who may not exhibit symptoms but will show abnormalities days before symptoms evolve.

This will be high risk groups or individuals, traveling from infected areas. The ‘targeted’ protocol will include the controlled testing of each individual (a single thermal image) which will have a greater specificity. The individual will be anterior to the camera, any spectacles or head covering removed and the head and neck will be imaged in a stable environment. (instead of just passing by the IR camera)  This group will fall into the asymptomatic category who will be best detected by individual screening checkpoints.

3. Establishing routine fever screening during outbreaks will deter individuals from traveling if they know or suspect that they have any symptoms whatsoever.

This group has the greatest potential to limit the spread through compliance with WHO and other advisory body recommendations (not to travel if you have been exposed to anyone infected or have any symptoms yourself).  ‘Nobody wants to be stopped and quarantined’.    

Conclusion:

Fever Screening stations will not prevent the spread of disease 100% but are an integral part of the effort to limit and contain the outbreak and reduce the number of deaths.  

It became immediately obvious that the level of training required for the operating technicians (and their wide range of abilities) made quick and strategic installations difficult and performance was variable.  There was a learning curve for both the trainee technicians as well as our support and installation personnel.

This experience highlighted the need for software design that was specific to the temperature range and detection of fever and that could be used by untrained operators.

A proprietary software program was developed by our engineers that provided pre-selected ranges of temperature with manually and automatically set alarms (threshold temperature) which would target any temperature above a selected range that passed in front of the detector.

The detector needed to be radiometric and calibrated to read real-time absolute temperature and be flexible enough to handle ambient temperature changes, varying degrees of unstable environmental conditions (caused by air conditioning, sunlight, electronic equipment, different types of lighting and reflective surfaces).

The result was the med520 which was tested extensively over the following year and was available when the avian flu outbreak took place.

There have been some additional software updates in the last year, which have made the operation of the system even more intuitive and now we are faced with another pandemic outbreak the med520 is ideally suited for very quick setup in any environment and to be operated by anyone with minimal computer skills in order to detect abnormal physiology.

The major benefit of the med520 is the ease of installation and operation. There is no formal training required for operators, the system is connected to a mains power supply (any country) or can run from a 9 v battery pack. It takes less than 5 minutes to set up and begin screening.

The auto threshold temperature means that the system will automatically find the normal body temperature of individual people, individuals among groups or individuals in crowds being scanned, this then sets the threshold alarm for anyone present with a fever or in fact any abnormal temperature ranges (which may include lower temperatures caused by evaporative cooling……. perspiration) 

We are not just looking for hot spots, the med520 uses proprietary algorithms to detect findings that are more accurate for specific symptoms like fever, inflammation and infection. The result is a low percent of false positive but more importantly, a very low potential for false negative.

• Medical grade sensitivity
• Fast identification of high risk individuals with an audible and visible alarm
• Designed to operate continuously 24 hours a day indefinitely