Answers to frequently asked questions
What type of doctor is qualified to provide the interpretation of thermograms?
What should I look for in choosing a qualified interpreting thermologist?
It’s all about tracing the education and lineage of the thermologist. What association credentialed the thermologist? How long has it been around? Who are the founding officers? Who were the thermologist’s instructors? What is their lineage?
Is the thermologist part of a group that just placed letters behind their names or did they earn their board certification through examination and years of field experience from an association of instructors that can trace their lineage? Does the interpreting thermologist use the internationally accepted TH grading standard for interpreting breast thermograms? Are the reports clear with regard to recommended follow-up?
Our group of independent thermologists can trace their lineage back to some of the original researchers, professors, and association founders. All of our doctors have undergone a quality education in clinical thermology that encompassed many hours of post-graduate classroom instruction, a supervised field residence, hundreds of sets of images co-read by a thermologist instructor, written examinations and a practical imaging examination before earning their board certification.
Are there any special protocols thermologists need to follow when analyzing thermograms?
Absolutely! And if they are not followed the images can be completely misread. This is a very serious question that also includes the method of analysis. Before choosing any interpretation service you need to review this topic in greater detail. For more information please contact us for an information packet.
Are there standards and guidelines for the interpretation of thermograms?
All imaging procedures have specific standards and guidelines that must be followed. Quality peer-reviewed and published research studies performed in leading universities have established a normative database of objective topographic thermal gradients and temperature values. Almost 10,000 references exist in the literature using this normative database to examine for pathology.
With regard to breast thermography, over 800 references exist in the literature to support the standards and guidelines under which breast thermograms are interpreted. All breast thermogram reports should contain a TH (thermobiological) grading of each breast. If a report does not grade each breast into one of 5 TH grades, the competency of the interpreting thermologist comes into question. The TH grading system was devised in order to provide a method for the universal interpretation of both qualitative and quantitative thermal data and to use this data to convey the level of risk and concern. Without a grading system there would also be no way to objectively monitor the progression of possible pathology or provide an objective indicator of improvement of the health of the breasts under care.
The TH grading system has been in place since the early 1980’s. The American College of Radiology (ACR) established the BIRADS (Breast Imaging Reporting and Data System) grading system in order to provide the same information when interpreting a mammogram, MRI, or ultrasound of the breast. The ACR states the following: “The BI-RADS provides standardized breast imaging findings terminology, report organization, assessment structure and a classification system for mammography, ultrasound and MRI of the breast. The report organization enables radiologists to provide a succinct review of mammography, ultrasound and MRI findings and to communicate the results to the referring physician in a clear and consistent fashion with a final assessment and a specific course of action.” MIR imaging uses the TH grading system to accomplish the same objectives.
Are there specific guidelines and protocols under which thermograms need to be taken in the office, imaging center, or hospital setting?
Yes, and without them the images would be useless. The standards and guidelines under which technicians provide MIR have been in-place since the early 1980’s. There are both pre-imaging protocols that patients must follow before coming in for imaging and there are also strict protocols under which the images are taken in the imaging suite.
In order to prevent artifacts on the images, every patient must be provided with a list of pre-imaging instructions that must be rigidly followed. The imaging room must also be designed properly and environmentally controlled within strict guidelines. The room itself should be draft free and relatively cool (68-73 degrees F) with no incandescent lighting, no heat or cooling sources near the patient, no windows without coverings, and environmentally held steady within 1 degree C during the entire time of the imaging study. In other words, you should be placed in a draft-free cool room that is very thermally stable. You will also need to spend 15 minutes acclimating to the room before imaging (nude from the waist up for breast imaging and with suitable underwear and a loose fitting gown for body imaging). And lastly, the imaging system itself must meet minimum acceptable specifications for medical use and be registered with the FDA in order to provide MIR. Without these standards in place the images would be of no value.
Are your reports clear on what follow up tests are needed?
Do you provide treatment recommendations on your reports?
Absolutely not! As thermologists it is our duty to NOT intervene in treatment. Your treatment must be directed by your primary care physician and/or medical specialist(s).
Even though we are doctors who provide patient care on a daily basis, do we know your complete health history? Have we reviewed all of your recent and past laboratory exams? Do we know all of the medications, supplements, herbals, etc. you are taking? Have we consulted with or at least have your complete health history from all the other health care providers/specialists involved in your care? Have we provided you with a recent physical examination to be sure of certain health markers? Can you imagine the level of irresponsibility a doctor would have to undertake to make treatment recommendations simply off the findings of a thermogram? There is a real possibility here that a patient could be seriously injured or worse.
As doctors, who are also thermologists, we would never write a report containing recommendations for treatment. The findings and recommendations on the report are sufficient enough for your doctor to use in providing care.
I've heard that after an initial thermogram the patient will need to return in 3 months for another thermogram so that a stable baseline can be established.
This is absolutely unnecessary! The argument for this practice seems to be that there is no way to know on your first thermogram whether or not your body was changing at the time. I have a question, if the follow-up 3 month thermogram showed that there was change, which image set would be the stable baseline? Would it be the first set or the 3 month later set? It sounds like you would need to do another set of images in another 3 months as a tie breaker. But what if this set also showed change? The bottom line is that if you did need to return to do any of this the technology must be useless.
What would you think if your doctor took your temperature, noted it as a fever, and then told you to return the next day to see if this first reading was right? Reading core temperature is no different than a surface recording taken under proper thermal imaging guidelines. Either the information taken on the first thermogram is valuable or the technology is unstable and useless. Research following patients for over 5 years has proven that the thermal patterns and differential temperatures at the surface of the body are remarkably stable and held within a very narrow range. These research studies were used to establish the normative database to which we compare patients when reading thermograms. Thermovascular patterns are as unique as a fingerprint and can be followed with accuracy for decades. It is when there is a change to this stable thermal fingerprint that a problem is signaled.
This begs the question as to why patients are being asked to return in 3 months. I would ask one of these offices for at least one peer-reviewed and published research paper demonstrating the need for this in order to establish a stable baseline. The research has already been done. In the early days of thermography each set of thermal images were taken in triplicate. The patient was acclimated in a temperature controlled imaging room under standard protocols for 15 minutes and then imaged. The patient would then be left for another 15 minutes and imaged again. This was finally repeated once more. In these early days thermologists were unsure about the stability of the process and the possibility of changes. Once the stability of the thermal data was established this practice was stopped. Then, as mentioned above, this was taken a step further by watching the thermal stability of patients for over 5 years. Studies have proven that a single set of thermal images taken under proper guidelines is completely accurate for analysis.
Under the established standards and guidelines for medical infrared imaging, recalling patients for follow-up thermograms is based solely on clinical need. When it comes to breast thermography, follow-up thermograms are performed based on the known metabolism of breast cancers. Under these guidelines each breast must be graded into one of 5 thermobiological (TH) categories. The level of TH grading acts as an individualized risk assessment based on the patients own biology. Depending on the TH grading, and taking into consideration the metabolism of breast cancers, the patient will be asked to return in a reasonable amount of time.
Since it was established over 30 years ago that a single thermogram is all that is needed for immediate analysis, why are some offices having all their initial thermogram patients return in 3 months?
Will our center be assigned a thermologist or will we be getting reports from multiple thermologists? We are concerned that if all the reports look different, patients and their doctors may become confused with their results.
Let me answer your second concern first. The last thing we would want is to have your patients and their doctors confused due to differing report formats. To prevent this from happening we have adopted a standardized report format and language that each thermologist in our group uses. There is no concern here.
In answer to your first question, your clinic may be assigned a specific thermologist or not. This will depend on the current demand for interpretations. We are always striving to get reports back in a timely manner. As such, your clinic may be served with one or more thermologists.
I've been told that when doing a breast thermogram a cold-challenge must be done.
The use of the cold-challenge (placing the patient’s hands in ice-water, using ice mitts, or using ice packs placed on the mid-back) was stopped in the late 1980’s. The research at the time showed that using the cold-challenge did not increase the sensitivity or specificity of breast thermography. What we are finding is that some offices have websites telling women that they should never go to any office or imaging center that is not doing the cold-challenge. We have no idea why they are doing this as this is simply false information. Fortunately, the number of offices we see doing this is decreasing.
Back in the late 1990’s and early 2000’s the problem was so bad that Dr. William Hobbins (the leading expert in breast thermography) approached Dr. Amalu. He knew that Dr. Amalu had done his own research and encouraged him to review his database of cold-challenges and present a paper at the yearly symposium of the American Academy of Thermology (AAT). Dr. Hobbins, and other experts in this field, were concerned that these misleading offices were claiming that experts in this field were missing things by not performing breast thermography correctly. The paper went on to be presented at the international conference of the IEEE Engineering in Medicine and Biology Society. The end result was acceptance of the paper for peer-review and publication (click here or go to Medline/PubMed). Since that time, both the IACT and the AAT convened guidelines committees that included Dr. Amalu, along with Dr. William Hobbins and a group of experts in this field, to review the current status of breast thermography and create internationally peer-reviewed standards and guidelines documents. With regard to the cold-challenge, a review of the literature along with a consensus among the experts determined that the cold-challenge did not improve the sensitivity or specificity of breast thermography; and as such, its use is not necessary to provide an accurate interpretation of medical infrared images of the breast.
Is MIR approved by the FDA?
Based upon the available research data at the time, the U.S. Department of Health Education and Welfare (HEW) determined that thermography was beyond the experimental stage in 1972. Thermography (MIR) was approved as an adjunctive imaging procedure by the FDA in 1982 (Federal Register, Vol 47, No. 20, pp 4419-4420, January 29, 1982). The FDA approved MIR as: “Telethermographic systems intended for adjunctive diagnostic screening for the detection of breast cancer and other uses” (Code of Federal Regulations – Title 21, Section 884.2980 Telethermographic Systems).
What makes MIR so different from other medical imaging technologies?
What most of us are accustomed to when we think of medical imaging is the use of X-ray, CT, MRI, or ultrasound. All of these imaging tools are considered structural imaging technologies; they look inside the body for structural changes such as broken bones, tumors, damage to organs, etc. What separates these technologies from infrared imaging is that MIR detects infrared (heat) markers that reflect the body’s subtle underlying chemical and nervous system signals. This allows us to look at how the body is functioning. These neurochemical signals may be the only sign that a problem exists, a remnant of injury indicating that healing has not finished, or a signal sent in advance of significant damage to the body. With this information in hand, you and your health care provider can outline a method for treating a current problem or possibly preventing future problems before they cause irreversible damage.
Many patients are also confused with regard to their condition. For example, patients with chronic pain who have had treatment with little or no relief may have been treated for the wrong condition. Infrared imaging has helped many patients get to the cause of their condition so that proper treatment can be rendered.
The applications of MIR are broad and range from simple soft tissue injury to a risk assessment marker for breast cancer. It is important to note that infrared imaging, like other imaging procedures (e.g. CT, MRI, mammography, ultrasound) does not provide a diagnosis. Infrared imaging cannot be used as a “body scan” to search for metastasis (the spread of cancer) or internal organ pathologies. There are many other tests that can provide true screening (early detection) for these conditions – MIR cannot. Infrared imaging is not a stand-alone test, but an additional procedure that your doctor can use along with other tests to evaluate your health. Only your physician can provide you with a diagnosis. The following list is just some of the conditions that have associated infrared thermal emission markers:
- Altered gait manifestations
- Arteriosclerosis (peripheral)
- Brachial Plexus Injury
- Breast Disease
- Carotid Artery Stenosis
- Carpal Tunnel Syndrome
- Chronic pain
- Compartment Syndromes
- Complex Regional Pain Syndrome (CRPS)
- Dental Irritation/Inflammation
- Diabetes (secondary complications)
- Disc Syndromes (spinal discogenic pain)
- Facet Syndrome
- Headache Evaluation (e.g. cervicogenic, migraine, sinus)
- Herniated Disc/Ruptured Disc
- Intervertebral Disc Disease
- Ligament Tears
- Lumbosacral Plexus Injury
- Muscular Spasm
- Muscle Tears
- Myofascial Irritation
- Myofascial Pain Syndrome
- Nerve Entrapment
- Nerve Impingement/Pressure
- Nerve Root Irritation
- Nerve Stretch Injury
- Neurovascular Compression
- Peripheral Nerve Abnormalities
- Pinched Nerves
- Referred Pain Syndromes
- Reflex Sympathetic Dystrophy (RSD)
- Repetitive Strain Injuries
- Raynaud’s Disease
- Rheumatoid Arthritis
- Sacroiliac Ligament Tear
- Sacroiliac Syndrome
- Sensory Nerve Abnormalities
- Sinus Irritation/Inflammation
- Skin Conditions
- Soft Tissue Injury
- Spinal Cord Injury
- Sports Injuries
- Superficial Vascular Disease
- Temporal Arteritis
- Thoracic Outlet Syndrome
- Thyroid Conditions
- TMJ Dysfunction (TMD)
- Trigeminal Neuralgia
- Trigger Points
- Whiplash Conditions
- And many more …
- Index Medicus – J Thermology, Acta Thermographica, J Breast
How does MIR help when imaging the breast?
The use of MIR is based on the principle that metabolic activity and vascular circulation in both pre-cancerous tissue and the area surrounding a developing breast cancer is almost always higher than in normal breast tissue. In an ever-increasing need for nutrients, cancerous tumors increase circulation to their cells by holding open existing blood vessels, opening dormant vessels, and creating new ones (neoangiogenesis). This process frequently results in an increase in regional surface temperatures and vascular patterning of the breast. MIR uses ultra-sensitive medical infrared cameras and sophisticated computers to detect, analyze, and produce high-resolution images of these temperature variations and vascular patterns. Because of MIR’s sensitivity, these thermovascular variations may be among the earliest signs of breast cancer or a pre-cancerous state of the breast (3,6,7,8,9).
Studies also show that an abnormal infrared image is the single most important marker of high risk for developing breast cancer, 10 times more significant than a family history of the disease (5). Consequently, in patients with a persistent abnormal thermogram, the examination results become a marker of higher future cancer risk (4,5). Depending upon certain factors, re-examinations are performed at appropriate intervals to monitor the breasts. This gives a woman time to take a pro-active approach by working with her doctor to improve her breast health. By maintaining close monitoring of her breast health with the combined use of screening imaging, self-breast exams, clinical examinations, and thermography, a woman has a much better chance of detecting cancer at its earliest stage and preventing invasive tumor growth.
- American Cancer Society – Breast Cancer Guidelines and Statistics, 2009-2010
- I. Nyirjesy, M.D. et al; Clinical Evaluation, Mammography and Thermography in the Diagnosis of Breast Carcinoma. Thermology, 1986; 1: 170-173.
- M. Gautherie, Ph.D.; Thermobiological Assessment of Benign and Malignant Breast Diseases. Am. J. Obstet. Gynecol., 1983; V 147, No. 8: 861-869.
- C. Gros, M.D., M. Gautherie, Ph.D.; Breast Thermography and Cancer Risk Prediction. Cancer, 1980; V 45, No. 1: 51-56.
- P. Haehnel, M.D., M. Gautherie, Ph.D. et al; Long-Term Assessment of Breast Cancer Risk by Thermal Imaging. In: Biomedical Thermology, 1980; 279-301.
- P. Gamigami, M.D.; Atlas of Mammography: New Early Signs in Breast Cancer. Blackwell Science, 1996.
- J. Keyserlingk, M.D.; Time to Reassess the Value of Infrared Breast Imaging? Oncology News Int., 1997; V 6, No. 9.
- P.Ahlgren, M.D., E. Yu, M.D., J. Keyserlingk, M.D.; Is it Time to Reassess the Value of Infrared Breast Imaging? Primary Care & Cancer (NCI), 1998; V 18, No. 2.
- N. Belliveau, M.D., J. Keyserlingk, M.D. et al ; Infrared Imaging of the Breast: Initial Reappraisal Using High-Resolution Digital Technology in 100 Successive Cases of Stage I and II Breast Cancer. Breast Journal, 1998; V 4, No. 4
Is infrared imaging of the body an alternative to X-ray, ultrasound, MRI, CT or any other type of imaging?
MIR is not an alternative to any other form of imaging. The technologies are completely different. One cannot compare a functional imaging technology (MIR) to structural imaging. For example, an EKG does not replace an echocardiogram. The two technologies look at the heart in a completely different way, yet they complement each other. Infrared imaging provides information about the body that no other technology can offer, but it does not replace them. The reason why there are so many different medical imaging technologies is because no one technology can do it all. They all have strengths and weaknesses.
Infrared imaging does not replace any other form of imaging, but is designed to be used in addition to other tests to provide physiological information that cannot be obtained from other examination procedures. MIR is an adjunctive physiologic imaging procedure that does not look inside the body. If patients, and their doctors, are interested in looking for internal pathological changes to the bones, liver, colon, female reproductive organs, heart, etc. then structural imaging studies (e.g. MRI, CT, ultrasound) would be good choices.
For breast imaging, does thermography replace mammograms, ultrasounds, or MRI?
Absolutely not! However, do these other imaging technologies replace thermography? The answer to this is also a resounding no; the tests complement each other. Thermography is adjunctive, it is to be used in addition to other imaging technologies as part of a woman’s regular breast health care. The consensus among health care experts is that no one procedure or method of imaging is solely adequate for breast cancer screening. The false negative and positive rates for currently used examination tests (including thermography) are too high for the procedures to be used alone. However, thermography may pick up thermal markers that may indicate the risk of cancers not detected by other tests. A positive infrared image is also the single most important marker of high risk for developing breast cancer in the future. It is thermography’s unique ability to monitor the abnormal temperature (physiological) and blood vessel changes produced by pathological breast tissue that allows for very early detection. Since it has been determined that 1 in 8 women will get breast cancer, we should use every means possible to detect these tumors when there is the greatest chance for survival. Adding these tests together significantly increases the chance for early detection.
Keep in mind that no one test or imaging technology can provide a warning for 100% of all cases. As such, all tests and imaging technologies are adjunctive. As an example, we think that very few doctors would tell a woman that all she needs is a mammogram and that she does not need to come in for her yearly physical breast exam. Doctors know that a certain number of breast cancers will be detected on a physical exam of the breasts and not detected on a mammogram. As such, a mammogram is also adjunctive – it must be used along with a yearly physical exam of the breast.
Another example of this “adjunctive” principle is the all too common experience of women having their yearly physical breast exam followed by their mammogram and then having to have a follow-up ultrasound to check on something seen on the mammogram. Now we are up to three “adjunctive” exams before a woman is told that everything looks fine. Now in some cases, if something needs to be watched on the mammogram and/or ultrasound, a woman might need to be called back in 6 months for another mammogram. MIR might be the added technology that calls attention to something that needs a closer look.
It should be understood that all of these imaging technologies (MIR included) cannot tell a woman if she has breast cancer. They only provide a certain amount of suspicion based on what the individual technologies “see”. Only a biopsy can tell a woman if she has breast cancer.
There just isn’t one single magic bullet that will do it all. As such, the best approach to providing every woman with the best in early breast cancer detection is a multi-modal approach (multiple modality – multiple tests).
I’ve heard that there are computer programs that can read thermograms.
I think that we need to clarify this question first. If you are asking if there is an FDA approved computer program that will read the images and create a report without a board certified thermologist also reading the images, the answer is no. There is no place anywhere in health care where a machine provides interpretation of a test and creates a report without a doctor’s interpretation of the results. Have you ever seen a report from any imaging procedure that did not have a doctor’s signature (electronic or otherwise)? This is completely unacceptable in health care. Also, can you imagine the liability! No company would be foolish enough to want to accept this level of responsibility for their software program.
On the other hand, there are quite a few experimental programs currently being studied that are designed to aid thermologists when interpreting thermograms. However, we are not aware of any programs that have been proven to be accurate and approved by the FDA. As such, there is no adequate research proving that any of these programs are of value to the thermologist.
These programs are designed to work just like the FDA approved programs presently being used to aid radiologists when reading mammograms (e.g. ImageChecker). Dr. Amalu is currently working with a group of experts in the field of remote sensing to create one of these digital CAD (computer aided detection) programs for use in MIR. However, a bit more time and a great deal of research will be needed before seeking FDA approval.
On a side note, research has shown that the skill level of radiologists in detecting suspicious areas on a mammogram is far greater than that of the CAD programs designed to aid them. It’s nice to know that we humans are still better than machines.