Digital Infrared BreastScan FAQ
What is Digital Infrared BreastScan?
Digital Infrared BreastScan technology and one of the few breast cancer screening technologies that has been developed with breast cancer in mind. It is the only known digital infrared technology that applies state-of-the-art algorithms to interpret the screening result, making the analysis less dependent of human interpretation.
Digital Infrared BreastScan is a breast screening technology. Its sole purpose is to identify potential breast abnormalities, just like mammography, ultrasound and MRI. The only way in which one can be 100% sure if an abnormality is cancer is by taking a biopsy.
Digital Infrared BreastScan requires the woman to disrobe and sit still in front of an infrared camera and cool air circulator for 4 minutes. Over this period approx. 1,000 digital pictures will be taken and analysed. There is no contact with the machine or the operator.
How safe is Digital Infrared BreastScan?
Digital Infrared BreastScan causes no health risks or side effects. It is safe for everyone. Digital Infrared BreastScan has been approved within EU (CE mark) and in US (FDA) as medical equipment and can freely be used with no restrictions. By November 2007 more than 20,000 Digital Infrared BreastScans have been performed in US with no complaints.
How accurate is Digital Infrared BreastScan?
Digital Infrared BreastScan has already been or is being tested at Yale, Cornell and Cambridge University hospitals in women with abnormalities. In the published study from Cornell Digital Infrared BreastScan picked up 97% of breast cancers.
Earlier versions of infrared technology (not digital) depended heavily on the interpretation of the person analysing the pictures taken which often lead to misinterpretation. This risk is now minimised by applying state-of the-art algorithms.
I take yearly mammograms, why should I have another screening test?
Digital Infrared BreastScan collects different data than other screening technologies. Mammography, ultrasound, MRI, and clinical breast examinations (CBE) detect anatomical features. Digital Infrared BreastScan detects physiological features associated with the growth and spread of cancer cells. This additional information will be used by the breast specialist reviewing your mammogram to make sure nothing was overlooked. If any abnormal areas were indicated on the digital infrared image, the doctor will give that area special attention so that cancer can be detected at the earliest stage possible.
How often do I need to take Digital Infrared BreastScan?
Digital Infrared BreastScan is typically taken yearly however it can be taken more frequently as recommended by your breast surgeon.
If Digital Infrared BreastScan can see cancer in advance, can't I take it every few years?
Although Digital Infrared BreastScans technology can detect abnormalities leading to cancer before a mass forms, in many cases cancerous masses have developed and formed within months. A yearly Digital Infrared BreastScan will help to ensure cancer will be detected at an earlier stage.
I have breast implants. Can I take Digital Infrared BreastScan?
Yes. Digital Infrared BreastScan is very helpful for women with breast implants since the implants will not affect the accuracy of the exams. Mammograms are sometimes unreliable in the case of implants because it is difficult to take a film of all the breast tissue. Further uncomfortable breast manipulation is necessary. This is not the case with Digital Infrared BreastScan.
Who can take Digital Infrared BreastScan?
This examination is recommended to all women over the age of 18 including women previously diagnosed with cancer, with implants, and especially women with dense or cystic breasts or family history of breast cancer.
No one in my family has been diagnosed with breast cancer. Why do I need to take another examination?
The majority of women diagnosed with breast cancer are the first members of their family to be diagnosed. Although family history is a high risk factor, an abnormal Digital Infrared BreastScan is 10 times more significant as a future risk factor than family history.
Does NHS or my insurance company cover Digital Infrared BreastScan?
No. NHS and insurance companies are currently not covering this screening test. This means that you will have to pay privately for the Digital Infrared BreastScan and for any follow-up treatment the Clinical Director may recommend and you decide to have.
What does Digital Infrared BreastScan cost?
Digital Infrared BreastScan £150. Screening report will be mailed to you and your GP of choice within 3-5 working days
What is the Digital Infrared BreastScan Well Women survey?
Approx. 1,000 women will be offered the opportunity to participate in a long term follow-up survey which key objective is to determine the long term success rate of Digital Infrared BreastScan in well women.
Well Women will be required to sign Consent Form and will thereafter once per year receive a 1 page form identifying general breast health and client satisfaction.
I have not recently had a mammogram but I want to take Digital Infrared BreastScan. What should I do?
Digital Infrared BreastScan has been approved by the EU (CE mark) and US authorities (FDA) as a diagnostic tool to be used in conjunction with mammography. For women too young to have a mammogram, Digital Infrared BreastScan can be used in conjunction with a clinical breast exam.
Can women too young to take mammograms take Digital Infrared BreastScan?
Yes. This exam is especially helpful for women not eligible yet for mammograms. Women in the 18 to 47 age category now have another tool in addition to a clinical breast examination that can detect breast cancer.
I have recently undergone radiation treatment; can I take Digital Infrared BreastScan today?
Women should wait at least one year after undergoing breast radiotherapy to take Digital Infrared BreastScan. However, if radiation was done on one breast, there is no need to wait 12 months to have Digital Infrared BreastScan results on the other breast.
Why haven’t I heard of Digital Infrared BreastScan before?
Some may have heard of breast thermography in past years. The tremendous advances in technology over the last 20 years have significantly increased the accuracy of infrared imaging tools. Digital Infrared BreastScan is a new examination and has been approved by the European (CE mark) and US authorities. In the coming months you can be sure you will receive more information from the news media as this exciting new tool becomes more widely use.
Can infrared imaging detect inflammatory breast cancer?
Inflammatory breast cancer (IBC) is a rare form of breast cancer that involves the skin of the breast and is rarely diagnosed easily with mammography. The only diagnosis is a biopsy, usually done after more advanced signs of the disease are observed clinically. One of the early signs of the disease includes an elevated breast temperature that increases over time as the disease advances. Digital Infrared BreastScan can detect even a slight increase in the breast temperature, and thus is an effective indicator of the potential for this condition. If significant temperature signs are observed with Digital Infrared BreastScan, and your breast surgeon suspects the possibility of IBC, he/she may order an early biopsy before other more advanced clinical signs become evident.
How is Digital Infrared BreastScan different from the thermography of the past?
Many GPs are aware of the past efforts to use thermography to detect breast cancer. The earliest investigations can be traced back to the 1950s. These early efforts, had varying degrees of success, wherein the effectiveness of the test was limited by two primary factors. The first was the sensitivity of the measurement device, and the second was the expertise of the person in reading the images. Despite these limitations, some doctors and researchers were able to demonstrate test effectiveness and have documented these results in numerous publications.
Digital Infrared BreastScan is unique, and unlike any system utilised in the past. It is the first of its kind, where there is no reading or interpretation of images, and it utilises the most advanced digital infrared camera and software technology available today. It further differs in that it provides a fully objective test report, and it does not require a specially qualified operator to conduct the test. The operator need not possess more knowledge than how to properly operate a computer mouse - BreastHealth UK, however only employs registered nurses for this job. Because Digital Infrared BreastScan is objective and under full computer control its results are repeatable. The report output cannot be influenced by the operator, and the computer self-tests the data to determine if it was recorded properly. The system even stores all operator input including mouse movement, so that a test can be repeated or re-analysed. Repeatability allows the Digital Infrared BreastScan to be used for establishment of a baseline, and then for comparison in future Digital Infrared BreastScans.
Have there been any published studies on infrared imaging for breast cancer detection?
There are approximately 800 published studies on infrared imaging involving over 300,000 women by some estimates. Two papers on Digital Infrared BreastScan have been published at the IEEE Engineering in Medicine and Biology Conference in 2003 and 2004. A third paper1 recently reported a 97% breast cancer detection rate using Digital Infrared BreastScan.
Arora, N., Martins, D., Ruggerio, D., Tousimis, E., Swistel, A.J., Osborne, M.P., Simmons, R.M. Effectiveness of a noninvasive digital infrared thermal imaging system in the detection of breast cancer. The American Journal of Surgery (2008) 196: 523-526
Is infrared able to detect cancer early? What does infrared detect?
Numerous studies have shown that infrared can detect the signs of developing cancer years before modalities such as mammography; by up to 10 years.
Infrared is able to detect the physiologic changes that are often associated with developing disease, as well as the detection of angiogenesis (new blood vessels that develop to feed cancerous tumors). Much of the past and current uses of this technology made measurements that, in one way or another, assessed the differences when comparing both breasts. Symmetry between breasts is one of the most telling signs that can be measured and quantified by Digital Infrared BreastScan. The determination of areas within the breasts that show a high degree of blood perfusion, or vessels that may be angiogenic, are also of importance. Proprietary software has been developed that locates these areas accurately, and is able to assign a value for the degree of abnormality. In nearly 100% of cases where there was a localized cancer (excluding inflammatory breast disease which may involve the whole breast), Digital Infrared BreastScan has accurately identified the location. A doctor using this road map of sites that exhibit abnormal signs, can then make a very thorough evaluation of the area. In some cases where these sites are within dense tissue and a proper assessment cannot be made by mammography, other modalities, such as ultrasound or MRI, may be indicated.
Is infrared a good predictor of risk?
One of the best studies on infrared as a predictor of risk, was published in 1983 by Gauthrie (Pasteur Institute, France). This study took a look at several hundred women spanning a 10 year period of systematic follow-up. Three groups of women were selected, each woman having initially healthy breasts (normal mammogram):
Control Group n=486
Women with primary family history of breast cancer and with a normal thermogram
Study Group 1 n=31
Women with primary family history of breast cancer and with an abnormal thermogram
Study Group 2 n=106
Women without primary family history of breast cancer and with an abnormal thermogram.
This study showed astonishing results. In ten years, 3.9% of the Control Group women were diagnosed with breast cancer, contrasted with 36% and 27% for Study Group 1 and Study Group 2, respectively. In fact, the study showed that 32% and 25% of Study Group 1 and 2 respectively, developed cancer within 3 years.
This fact clearly shows that primary family history is not as robust an indicator of risk, as is an abnormal infrared. Studies have concluded that an abnormal infrared is 10 times better an indicator of risk than a primary family history.
Does infrared imaging form a good baseline test for comparison with future infrared testing? How early can infrared detect the signs of breast cancer?
Since Digital Infrared BreastScan is fully objective, and always utilises the same analysis techniques for every person every time, it is very useful for establishing a baseline report for comparison to future reports. This will allow the breast specialist to monitor for changes, which may be an advance warning for development of disease. Since infrared has been shown to detect these signs up to 10 years in advance, the woman and doctor can plan a careful program for follow-up testing or monitoring, and ample time to correct any lifestyle risk factors (smoking, obesity, HRT, etc.).
How many women have been clinically tested with Digital Infrared BreastScan?>
Development of BreastScan started in 1999, and since that time has tested over 2,500 women in clinical trials. These clinical tests took place in two mammography facilities, and one oncology center, over the years spanning 1999 to the present. The women, ranging in age from 35 to 80 years were included in these studies. They comprised three groups; those believed cancer free, those with newly discovered cancer, and those who previously had a diagnoses of cancer. The first group consisted of approximately 2,300 women with no known cancer (presumed normal). The second group was comprised of approximately 100 women with newly detected, biopsy proven cancer, and the third group included approximately 70 women who underwent treatment (includes any combination of surgical, chemo or radiation) for proven malignancy 0 to 10 years previously. Included in the cancer cases, were three cases undetectable by mammography alone and were found only on ultrasound examination. Various types of malignancy were represented in this sample, including, DCIS, LCIS, invasive ductal carcinoma, invasive lobular carcinoma, and inflammatory carcinoma; in some cases with lesions as small as 4 mm. Today more than 20,000 women have been screened.
What is the sensitivity of the test? What about false positives?
Digital Infrared BreastScan is approved for use as an adjunctive test in breast cancer detection and screening. It is NOT a diagnostic test. In fact, mammography, ultrasound, MRI, CT, etc. are also NOT diagnostic tests. None of these imaging tests have the ability to diagnose cancer. Only a biopsy can answer this question.
Any test that is to be used in a screening role should have sensitivity as high as possible. The sensitivity of a test is to insure there are no false negatives, i.e. missed cancers. In order to determine the sensitivity of a test it is necessary to conduct studies on positive women whose outcome is known (or becomes known thereafter). Simply, all of the women in a study need to have a biopsy, and the pathology determined with a high degree of accuracy. This allows the test’s sensitivity to be determined as the percentage of correct positive determinations. Digital Infrared BreastScan continues to demonstrate a sensitivity of over 96%.
Questions are often asked about false positives in infrared imaging. The false positive rate is a measure of a test’s specificity, and a diagnostic test should have a specificity as high as possible.
Sensitivity and Specificity are two parameters that are often the inverse of one another, and rarely is there a test that exhibits outstanding performance in both categories simultaneously. There are no tests like that for screening of breast cancer. Mammography, being the only stand-alone FDA approved screening test, is only acceptable for women with fatty breast tissue, but lees so for women with dense breast tissue.
Digital Infrared BreastScan is unique among breast cancer screening, in that it is the only one with prognostic qualities, i.e. predictive ability. That being the case, it is inappropriate to measure specificity, or false positives, except in a very general way. Since infrared can warn of disease 10 years before current modalities can detect it, today’s false positive can become tomorrow’s true positive, so what is it properly called today? It is for this reason that a test that is prognostic should not have its specificity measured except over an appropriately long time frame.
Suffice to say that it is the opinion of those doctors expert in this area that about 25-30% of women should test positive on their initial infrared report. Only 8% of women fail Digital Infrared BreastScan examination with a highly abnormal report, and with no immediate cancer detected. It is believed that this group will be those that make up the population of women, of which 30-35% will get cancer within 10 years.
A woman that finds themselves in this category may experience additional anxiety. This is unavoidable; however consider that most women already believe they are at risk for breast cancer. This additional piece of breast health/risk data will allow the woman and her doctor to exercise the most rigorous monitoring program in order to detect the cancer at its earliest treatable size. With this level of advanced warning, early lifestyle changes combined with preventive treatment may be able to change the course of the disease. A positive infrared finding, when no cancer is detected serves as a clinical risk marker for the doctor and woman. No earlier detection can be made when being armed with the data that infrared imaging can provide, and watching as closely as possible with every detection modality at your disposal.
What are the risks to the woman? Is there any radiation?
Digital Infrared BreastScan is completely non-invasive and poses no risks whatsoever to the woman. The system does not emit any harmful radiation, but instead measures the infrared radiation that naturally emanates from the human body. Additionally, as there is no contact with the woman, no compression of the breasts is needed. During the administration of the test, the woman sits, disrobed from the waist up, in a chair facing Digital Infrared BreastScan camera. Once the automatic test sequence is commenced, the computer controls all aspects of the test. During the 4-minute recording phase, cool air is directed at the breasts. After recording, the woman is free to leave. The entire process takes about 5 minutes.
Who can benefit from Digital Infrared BreastScan? Does this test diagnose cancer and replace mammography? Is this test useful for young women that do not yet receive mammography?
Simply, all women can benefit from Digital Infrared BreastScan for breast cancer detection (including pregnant women and those breastfeeding). It is an adjunctive test that does not diagnose cancer, and is not a replacement for mammography.
Digital Infrared BreastScan can supplement the Clinical Breast Examination (CBE), if the women is not yet of age to receive a mammography. Digital Infrared BreastScan is a useful adjunct for women with dense breast tissue, where mammography is less effective, especially true in younger women.
The Digital Infrared BreastScan test helps the Clinical Director assess the overall breast health, and will serve as a clinical marker for the doctor to utilize in the examination of mammography, ultrasound, MR, or CBE, data. Based on the excellent negative predictive value demonstrated in our studies, and combined with the low prevalence of the disease, it is likely that any woman that tests negative with Digital Infrared BreastScan has that extra degree of assurance that nothing was missed.
What recommendations might be made by the woman's doctor following an abnormal infrared test in a young woman?
If a woman is of high risk, follow up testing is indicated with non-invasive tests being on the front line. This testing can be as simple as a very thorough CBE, or as involved as a breast MRI. Ultrasound, also non-invasive, may be utilised however with the understanding that the most prevalent breast cancer, DCIS, is not normally detected by this modality.
Clearly, just the knowledge that one is demonstrating additional risk with an abnormal Digital Infrared BreastScan report is useful in itself. Changes in lifestyle, improved frequency of CBE or BSE (breast self examination), or close monitoring, are all courses of action that can help avoid or detect the disease early. As previously stated, there can be no earlier detection than to know whom to watch, and where in the breast to focus on.