The benefit of breast thermography is that it offers the opportunity of earlier detection of breast disease than has been possible through breast self examination, doctor examination or mammography alone.

Thermography can detect the subtle physiologic changes that accompany breast pathology, whether it is cancer, fibrocystic disease, an infection or a vascular disease. Your doctor can then plan accordingly and lay out a careful program to further
diagnose and /or MONITOR you during and after any treatment.

Normal

Good thermal symmetry with no suspicious vascular patterns or significant thermal findings.

Fibrocystic Changes

The very significant vascular activity in the left breast justified clinical correlation and close monitoring which returned an opinion of fibrocystic changes taking place.

These changes can be monitored thermographically at regular intervals until a stable baseline is established and is reliable enough for annual comparison.

Early Stage Malignant Tumor

This is the specific area of a small DCIS. We can see the vascular feed and the discreet area of hypothermia that is displacing the surrounding hyperthermia.

Thermography is a painless, non invasive, state of the art clinical test without any exposure to radiation and is used as part of an early detection program which gives women of all ages the opportunity to increase their chances of detecting
breast disease at an early stage. It is particularly useful for women under 50 where mammography is less effective.

Thermography’s role in breast cancer and other breast disorders is to help in early detection and monitoring of abnormal physiology and the establishment of risk factors for the development or existence of cancer. When used with other procedures the best possible evaluation of breast health is made.

This test is designed to improve chances for detecting fast-growing, active tumors in the intervals between mammographic screenings or when mammography is not indicated by screening guidelines for women under 50 years of age.

All patients thermograms (breast images) are kept on record and form a baseline for all future routine evaluations.

This patient’s thermograms have remained stable for two years. These patterns are like a thermal fingerprint which will only change if pathology develops.

Baseline	3 Month Follow-up
First Annual	Second Annual

With the new ultra-sensitive, high resolution digital infrared cameras available today a technology that has been developing over the past 20 years is now becoming more accessible.

Thermography as a physiologic test, demonstrates heat patterns that are strongly indicative of breast abnormality, the test can detect subtle changes in breast temperature that indicate a variety of breast diseases and abnormalities and once abnormal heat patterns are detected in the breast, follow-up procedures including mammography are necessary to rule out or properly diagnose cancer and a host of other breast diseases such as fibrocystic syndrome, Pagets disease, etc.

Canadian researchers recently found that infrared imaging of breast cancers could detect minute temperature variations related to blood flow and demonstrate abnormal patterns
associated with the progression of tumors. These images or thermograms of the breast were positive for 83% of breast cancers compared to 61% for clinical breast examination alone and 84% for mammography.

By performing thermography years before conventional mammography, a selected patient population at risk can be monitored more carefully, and then by accurately utilize mammography or ultrasound as soon as is possible to detect the actual lesion – (once it has grown large enough and dense enough to be seen on mammographic film), can increase the patients treatment options and ultimately improve the outcome.

It is in this role that thermography provides its most practical benefit to the general public and to the medical profession. It is certainly an adjunct to the appropriate usage of mammography and not a competitor. In fact, thermography has the ability to identify patients at the highest risk and actually increase the effective usage of mammographic imaging procedures.

Until such time as a cure has been found for this terrible disease, progress must be made in the fields of early detection and risk evaluation coupled with sound clinical decision making.

Thermography, with its non-radiation, non-contact and low-cost basis has been clearly demonstrated to be a valuable and safe early risk marker of breast pathology, and an excellent case management tool for the ongoing monitoring and  treatment of breast disease when used under carefully controlled clinical protocols.

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

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.  

As concern continues to mount about the spread of the swine flu globally, airport authorities are responding by using digital thermal imaging technology to scan passengers. Thermal imaging can detect elevated body temperature, one of the signs of the virus N1H1 (swine flu).

“Medical thermal imaging at airports and any other locations where the public congregate targets individuals who are already symptomatic and likely to be infectious,” says Peter Leando, Ph.D., Managing Director of Meditherm. Meditherm’s thermal imaging system is one of the only digital thermal imaging scanners designed specifically for the human body giving the airport authorities the accuracy that they are looking for to identify infected passengers travelling from country to country. The company’s  medical  thermal imaging systems are in use at airports in Aruba, Australia, Bahrain, Brazil, Dominican Republic, Hong Kong, India, Indonesia, Israel, Kuwait, Malaysia, New Zealand, Oman, the Philippines, Qatar, Saudi Arabia, Singapore, Turkey and the United Arab Emirates.

The highest risk for the geographic spread of infection is through travel and “seeding”.  Thermal imaging of travelers has several benefits:

• Sensitive screening to detect abnormal physiology (hot or cold) will have a  high percentage of accuracy in detecting abnormal temperatures, which then leads to further testing of an individual in order to confirm symptoms or rule out clinical suspicion.  This group will generally already be symptomatic and are best detected with a mass screening approach including rapid movement through airports.

• Sensitive but targeted screening can detect individuals who may not exhibit symptoms but will show abnormalities days before symptoms evolve. This will include high risk groups of individuals, traveling from infected areas.

• 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 by complying with the World Health Organization and other advisory body recommendations not to travel if you have been exposed to anyone infected or have any symptoms yourself.     

While fever screening stations will not prevent the spread completely, they are an integral part of the effort to limit the outbreak and reduce the number of deaths, says Dr. Leando.  

In recent days, more orders have been placed for Meditherm’s medical thermal imaging system from customers wanting to screen not only in airports but in large corporations, manufacturing plants and even public entertainment fascilities in the UK, Saudi Arabia, United Arab Emirates, St Martin, USA, Puerto Rico and Argentina, with enquiries also coming from several other countries, including Mexico.

About Meditherm

Based in Fort Myers, Florida, privately-owned Meditherm Inc. manufactures and distributes the Med 5220 and Med 520 line of digital thermal imaging systems, also known as Fever Screen Stations. Meditherm is currently the only medical device manufacturer building IR equipment exclusively for medical and clinical use and more than 2,000 Meditherm scanners are currently in use worldwide for a wide range of medical uses including fever screening, sports medicine, breast screening, pain clinics, and vascular studies which include stroke risk evaluation and deep vein thrombosis. www.meditherm.com

Meditherm’s Peter Leando is available for interviews to discuss thermal imaging.

Peter Leando

Managing Director, Meditherm Inc

1-239-334-8833

peter@meditherm.com