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The role of infrared imaging in the detection of cancer

In order to determine the value of infrared imaging, two viewpoints must be considered: first, the sensitivity of Thermograms taken preoperatively in patients with known breast carcinoma; and second, the incidence of normal and abnormal Thermograms in asymptomatic population (specificity) and the presence or absence of malignancy in each of these groups.

In 1965, Gershon – Cohen, a radiologist and researcher from the Albert Einstein Medical Center, introduced infrared imaging to the USA [35]. Using a Barns thermograph, he reported on 4000 cases with a sensitivity of 94% and a false positive rate of 6%. This data was included in a review of the then current status of infrared imaging published in 1968 in California – A Cancer Journal for Physicians [36].

In prospective studies, Hoffman first reported on thermography in gynecologic practice. He detected 23 carcinomas in 1924 patients (a detection rate of 12.5 per 1000), with an 8.4% false negative (91.6% sensitivity) and 7.4% false positive (92.6% specificity) rate [37].

Stark and way screened 4621 asymptomatic women, 35% of whom women were under 35 years of old age, and detected 24 cancers (detection rate of 7.6 per 1000) with a sensitivity and specificity of 98.3 and 93.5% respectively [38].

In a study comprising 25,000 patients screened and 1878 histologically proven breast cancers, Amalric and Spitalier reported on their results with infrared imaging. From this group, a false-negative and false positive rate of 9% (91% sensitivity and specificity) was found [39].

In a mobile unit examination of rural Wisconsin, Hobbins screened 37,506 women using Thermography.
He reported the detection of 5.7 cancers per 1000 women screened with a 12% false-negative and 14% false positive rate. His findings also corroborated with others that Thermography is the sole early initial signal in 10% of breast cancers. [17, 40].

Reporting his Radiology division’s experience with 10,000 thermographic studies done concomitantly with mammography over a 3 year period, Isard reiterated a number of important concepts including the remarkable thermal and vascular stability of the infrared image from year to year in the otherwise healthy patient and the importance of recognizing any significant change. (41) . In his experience, combining these modalities increased the sensitivity rate of detection by approximately 10%; thus, underlining the complementarity of these procedures since each one did not always suspect the same lesion.
It was Isard’s conclusion that, had there been a preliminary selection of his group of 4393 asymptomatic patients by infrared imaging, mammography examination would have been restricted to the 1028 patients with abnormal infrared imaging, or 23% of this cohort. This would have resulted in a cancer detection rate of 24.1 per 1000 combined infrared and mammographic examinations as contrasted to the expected 7 per 1000 by mammography screening alone. He concluded that since infrared imaging is innocuous examination, it could be utilized to focus attention upon asymptomatic women who should be examined more intensely. Isard emphasized that, like mammography and other breast imaging techniques, infrared imaging does not diagnose cancer, but merely indicates the presence of an abnormality.

Spitalier and associates screened 61,000 women using thermography over 10 year period. The false negative and false positive rate was found to be 11% (89% sensitivity and specificity). Thermography also detected 91% of the non palpable cancers (grade T 0: tumors less than 1 cm in size). The authors noted that of all the patients with cancer, thermography alone was the first Alarm in 60% of the cases [42]. Two small scale studies by Moskowitz (150 patients) [43] and Treatt (515 patients) [44] reported on the sensitivity and reliability of infrared imaging. Both used unknown experts to review the images of breast cancer patients. While Moskowitz excluded unreadable images, data from Threatt’s study indicated that less than 30% of the images produced were considered well, the rest being substandard. Both of this studies produced poor results; however, this could be expected considering the lack of adherence to accepted imaging methods and protocols. The greatest error in these studies is found in the methods used to analyze the images. The type of image analysis consisted of the sole use of abnormal vascular pattern recognition. At the time these studies were performed, the accepted method of infrared image interpretation consisted of a combined vascular pattern and quantitative analysis of temperature variation across the breasts. Consequently, the data obtained from theses studies is highly questionable. Their findings were also inconsistent with numerous previous large scale multi center trials. The authors suggested that for infrared imaging to be truly effective as a screening tool, there needed to be a more objective means of interpretation and proposed that this would be facilitated by computerized evaluation. This statement is interesting considering that recognized quantitative and qualitative reading protocols (including computer analysis) were being used at the time.
In a unique study comprising 39,802 women screened over a 3 year period, Haberman and associates used thermography and physical examination to determine if mammography was recommended. They reported 85% sensitivity and 70% specificity for thermography.

Haberman cautioned that the findings of thermographic specificity could not be extrapolated from this study as it was well documented that long term observation (8to 10 years or more) is necessary to determine a true false positive rate. The authors noted tat 30% of the cancers found would not have been detected if it were not for thermography [45] Gros and Gautherie reported on a large scale study comprising 85,000 patients screened. Culmination of the data resulted in a 90% sensitivity and 88% specificity for thermography. [46-49].

In a large scale multi center review of nearly 70,000 woman screened, Jones reported a false negative and false positive rate of 13% (87% sensitivity) and 15% (85% specificity), respectively for thermography [50].

In a study performed in 1986, Usuki reported on the relation of thermo graphic findings in breast cancer diagnosis. He noted an 88% sensitivity for thermography in the detection of breast cancers [51].
Parisky and associated published a study from a multi center 4 year clinical trial using infrared imaging to evaluate mammographically suspicious lesions. Data from a blinded subject set was obtained in 769 women with 875 biopsied lesions resulting in 187 malignant and 688 benign findings. The index of suspicion resulted in a 97% sensitivity in the detection of breast cancers [52].

In a study comparing clinical examination, mammography, and thermography in the diagnosis of breast cancer, three groups of patients were used: 4716 patients with confirmed carcinoma, 3305 patients with histologically diagnosed benign breast disease, and 8757 general patients (16,778 total participants). This paper also compared clinical examination and mammography to other well known studies in the literature including the National Cancer Institute (NCI) sponsored Breast Cancer Detection and Demonstration projects (BCDDPs). In this study, clinical examination had an average sensitivity of 75% in detecting all tumors and 50% in cancers less than 2 cm in size. This rate is exceptionally good when compared to many other studies at between 35 and 66% sensitivity. Mammography was found to have an average of 80% sensitivity and 73% specificity. Thermography had an average sensitivity of 88% (85%in tumors less than 1 cm in size) and specificity of 85%. An abnormal Thermogram was found to have a 94% predictive value. From the findings in this study, the authors suggested that “none of the techniques available for screening for breast carcinoma and evaluating patients with breast related symptoms is sufficiently accurate to be used alone. For the best results, a multimodal approach should be used [53]”.
In a series of 4000 confirmed breast cancers, Thomassin and associates observed 130 sub clinical carcinomas ranging in diameter of 3 to 5 mm. Both mammography and thermography were used alone and in combination. Of the 130 cancers, 10% were detected by mammography, 50% by thermography and 40% by both techniques. Thus, there was a thermal alarm in 90% of the patients and the only sign in 50% of the cases.(54)
In a simple review of over 15 large scale studies from 1967 to 1998, infrared imaging of the breast has showed an average sensitivity and specificity of 90%. With continued technological advances in infrared imaging in the past decade, some studies are showing even higher sensitivity and specificity values. However, until further large scale studies are performed, these findings remain in question.

INFRARED IMAGING AS A RISK INDICATOR

As early as 1976 at the Third International Symposium on Detection and Prevention of Cancer held in New-York, thermal imaging was established by consensus as the highest risk marker for the possibility of the presence of an undetected breast cancer. It had also been shown to predict such a subsequent occurrence (55-57). The Wisconsin Breast Cancer Detection Foundation presented summary of its findings in this area, which has remained undisputed (58). This, combined with other reports, has been confirmed that an abnormal infrared image is the highest risk indicator for the future development of breast cancer and is 10 times as significant as a first-order family history of the disease.(48)
In a study of 10,000 women screened, Gautherie found that, when applied to asymptomatic women, thermography was very useful in assessing the risk of cancer by dividing patients into low – and high risk categories. This was based on an objective evaluation of each patient’s thermograms using an improved reading protocol that incorporated 20 Thermo- pathological factors. (59)
A screening of 61,000 women using Thermograph was performed by Spitalier over a 10 year period. The authors concluded that “in patients having no clinical or radiographic suspicion of malignancy, a persistently
Abnormal breast thermogram represents the highest known risk factor for the future development of breast cancer”.(42)

From a patient base of 58,000 women screened with thermography, Gros and associates followed 1527 patients with initially healthy breasts and abnormal thermograms for 12 years. Of this group, 44% developed malignancies within 5 years. The study concluded that “an abnormal thermogram is the single most important marker of high risk category for the future development of breast cancer” [49]
Spitalier and associates followed 1416 patients with isolated abnormal breast thermograms. It was found that a persistently abnormal thermogram, as an isolated phenomenon, is associated with an actuarial breast cancer, a risk of 26% at 5 years. Within this study, 165 patients with no palpable cancers were observed. In 53% of these patients, thermography was the only test which was positive at the time of initial evaluation.
It was concluded that:

1. A persistently abnormal thermogram, even in the absence of any other sign of malignancy, is associated with a high risk of developing cancer.
2. This isolated abnormality also carries with it a high risk of developing interval cancer and as such the patient should be examined more frequently than the customary 12 months.
3. Most patients diagnosed as having minimal breast cancer have abnormal thermograms as the first warning sign.[60,61]
   In a study by Gautherie and associates, the effectiveness of thermography in terms of survival benefit was discussed. The authors analyzed the survival rates of 106 patients in whom the diagnosis of breast cancer was established as a result of the follow up of thermographic abnormalities found on the initial examination when the breasts were apparently healthy (negative physical and mammography findings). The control group consisted of 372 breast cancer patients. The patients in both groups were subjected to identical treatment and followed for 5 years. A 61% increase in survival was noted in the patients who were followed up due to initial thermographic abnormalities. The authors summarized the study by stating that “the findings clearly establish that the early identification of women at high risk of breast cancer based on the objective thermal assessments of breast health results in a dramatic survival benefit”. [62, 63]
   Infrared imaging provides a reflection of functional tumor – induced angiogenesis and metabolic activity rather than structurally based parameters (i.e., tumor size, architectural distortion, and micro calcifications). Recent advances in cancer research have determined that the biological activity of a neoplasm is far more significant an indicator of aggressiveness than the size of a tumor. As a direct reflection of the biological activity in the breast, infrared imaging has been found to provide a significant biological risk marker for cancer.

9.5 INFRARED IMAGING AS A PROGNOSTIC INDICATOR

Studies exploring the biology of cancers have shown that the amount of thermovascular activity in the breast is directly proportional to the aggressiveness of the tumor. As such, infrared imaging provides the clinician with an invaluable tool in prognosis and treatment monitoring.
In a study of 209 breast cancers, Dilhuydy and associates found a positive correlation between the degree of infrared abnormalities and the existence of positive axillary lymph nodes. It was reported that the amount of thermovascular activity seen in the breast was directly related to the prognosis. The study concluded that infrared imaging provides a highly significant factor in prognosis and that it should be included in the pre therapeutic assessment of a breast cancer.(64)
Amalric and Spitalier reported on 25,000 patients screened and 1878 histological proven breast cancers investigated with infrared imaging. The study noted that the amount of infrared activity in the breast was directly proportional to the survival of the patient. The “hot” cancers showed a significantly poorer prognosis with a 24% survival rate at 3 years. A much better prognosis with an 80% survival rate at 3 years was seen in more biologically inactive or “cooler” cancers. The study also noted a positive association between the amount of thermal activity in the breast and the presence of positive axillary nodes (65).
Reporting on a study of breast cancer doubling times and infrared imaging, Fournier noted significant changes in the thermovascular appearance of the images. The shorter the tumor doubling time, the more thermographic pathological signs were evident. It was concluded that infrared imaging served as a warning signal for the faster-growing breast cancers.(66)
A retrospective analysis of 100 normal patients, 100 living cancer patients, and 126 deceased cancer patients was published by Head.
Infrared imaging was found to be abnormal in 28% of the normal patients, compared to 65% of the living cancer patients and 88% of the deceased cancer patients. Known prognostic indicators related to tumor growth rate were compared to the results of the infrared images.
The concentration of tumor ferreting, the proportion of cells in DNA synthesis and proliferating, and the expression of the proliferation-associated tumor antigen Ki – 67 were all found to be associated with an abnormal infrared image. It was concluded that “the strong relationships of thermographic results with this three growth rate related prognostic indicators suggest that breast cancer patients with abnormal thermograms have faster growing tumors that are more likely to have metastasized and to recur with a shorter disease free interval”. (20)
In a paper by Gros and Gautherie, the use of infrared imaging in the prognosis of treated breast cancers was investigated. The authors considered infrared imaging to be absolutely necessary for assessing pre therapeutic prognosis or carrying out the follow-up of breast cancers treated by exclusive radiotherapy.
They noted that before treatment, infrared imaging yields evidence of the cancer growth rate (aggressiveness) and contributes to the therapeutic choice. It also indicates the success of radio- sterilization or the suspicion of a possible recurrence or radio- resistance. The authors also noted a weaker 5 years survival with infrared images that showed an increase in thermal signals.(67)
In a recent study by Keyserlingk, 20 women with core biopsy proven locally advanced breast cancer underwent infrared imaging before and after chemohormono-therapy. All 20 patients were found to have abnormal thermovascular signs prior to treatment. Upon completion of the final round of chemotherapy, each patient underwent curative-intent surgery. Prior to surgery, all 20 patients showed improvement in their initial infrared scores. The amount of improvement in the infrared images was found to be directly related to the decrease in tumor size. A complete normalization of pre chemotherapy infrared scores was seen in five patients. In these patients, there was no histological evidence of cancer remaining in the breast. In summary, the authors stated that “Further research will determine whether lingering infrared detected angiogenesis following treatment reflects tumor aggressiveness and ultimately prognosis, as well as early tumor resistance, thus providing an additional early signal for the need of a therapeutic adjustment”.(68)

9.7. Mammography and infrared imaging

From a scientific standpoint, mammography and infrared imaging are completely different screening tests. As a structural imaging procedure, mammography cannot be compared to a functional imaging technology such as infrared imaging. While mammography attempts to detect architectural tissue shadows, infrared imaging observes for changes in the subtle metabolic milieu of the breast. Even though mammography and infrared imaging examine completely different aspects of the breast, research has been performed that allows for a statistical comparison of the two technologies. Since a review of the research on infrared imaging has been covered, Data on the current state of mammography is presented. In a study by Rosenberg, 183,134 screening mammograms were reviewed for changes in sensitivity due to age, breast density, ethnicity, and estrogen replacement therapy.
Out of these screening mammograms 807 cancers were discovered at screening. The results showed that the sensitivity for mammography was 54% in women younger than 40 years, 77% in women aged 40 to 49, 78% in women aged 50 to 64, and 81% in women older than 64 years. Sensitivity was 68% in women with dense breasts and 74% in estrogen replacement therapy users.(73)
Investigating the cumulative risk of a false positive result in mammographic screening, Elmore and associates performed a 10 year retrospective study of 2400 women aged 40 to 69 years of age. A total of 9762 mammograms were investigated. It was found that a woman had an estimated 49.1% cumulative risk of having a false positive result after ten mammograms. Even though no breast cancer was present, over one third of the women screened were required to have additional evaluations.(74)
In a review of the literature, Head investigated the sensitivity, specificity, positive predictive value, and negative predictive values for mammography and infrared imaging. The average reported performance for mammography was 86% sensitivity, 79% specificity, 28% positive predictive value, and 92% negative predictive value. For infrared imaging the averaged performance was: 86% sensitivity, 89% specificity, 23% positive predictive value, and 99.4 % negative predictive value.(75)

Pisano, along with a large investigational group, provided a detailed report on the digital mammographic imaging Screening Trial (DMIST). The study investigated the diagnostic performance of digital vs. film mammography in breast cancer screening. Both, digital and film mammograms were taken on 42,760 asymptomatic women presenting for screening mammography. Data was gathered from 33 sites in the united state and Canada. Digital mammography was found to be more accurate in women under age 50 and in women whose breasts were radiographically dense. The sensitivity for both film and digital mammography was found to be 69%.(76).
Keyserlingk and associates published a retrospective study reviewing the relative ability of clinical examinations, Mammography, and infrared imaging to detect 100 new cases of ductal carcinoma in situ stage 1 and 2 breast cancers. Results from the study found that the sensitivity for clinical examination alone was 61%, mammography alone was 66%, and infrared imaging alone was 83%. When suspicious and equivocal mammograms were combined the sensitivity was increased to 85%. A sensitivity of 95% was found when suspicious equivocal mammograms were combined with abnormal infrared images. However, when clinical examination, mammography, and infrared images were combined a sensitivity of 98% was reached.(77)
From a review of a cumulative literature database, it can be found that the average sensitivity and specificity for mammography is, at best, 80 and 79%, respectively, for women over the age of 50. (78-80)
A significant decrease in sensitivity and specificity is seen in women below this age. This same research also shows that mammography routinely misses interval cancers (cancers that form between screening exams)(80) that may be detected by infrared imaging. Taking into consideration all the available data, mammography leaves much to be desired as the current gold standard for breast cancer screening. As a stand alone screening procedure, it is suggested that mammography may not be the best choice. In the same light, infrared imaging should also not be used alone as a screening test. The two technologies are of a complimentary nature. Neither used alone are sufficient, but when combined each builds on the deficiencies of the other. In reviewing the literature it seems evident that a multimodal approach to breast cancer screening would serve women best. A combination of clinical examination, mammography, and infrared imaging would provide the greatest potential for breast conservation and survival.

9.10 Conclusion

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The large patient populations and long survey periods in many of the above clinical studies yields a high significance to the various statistical data obtained. This is especially true for the contribution of infrared imaging to early cancer diagnosis, as an invaluable marker of high risk populations, and in therapeutic decision making.

Currently available of high resolution digital infrared imaging technology benefits greatly from enhanced image production, computerized image processing and analysis and standardized image interpretation protocols. Over 40 years of research and 800 indexed papers encompassing well over 300,000 women participants has demonstrated infrared imaging’s abilities in the early detection of breast cancer. Infrared imaging has distinguished itself as the earliest detection technology for breast cancer. It has the ability to signal an alarm that a cancer may be forming up to 10 years before any other procedure can detect it. In seven out of ten cases, infrared imaging will detect signs of a cancer before it is seen on a mammogram. Clinical trials have also shown that infrared imaging significantly augments the long term survival rates of its recipients by as much as 61%. And when used as part of a multimodal approach (clinical examination, mammography and infrared imaging), 95% of all early stage cancers will be detected. Ongoing research into the thermal characteristics of breast pathologies will continue to investigate the relationships between Neoangiogenesis, chemical mediators, and the neoplastic process.
It is unfortunate, but many clinicians still hesitate to consider infrared imaging as a useful tool in spite of the considerable research database, steady improvements in both infrared technology and image analysis, and continued efforts on the part of the infrared imaging societies. This attitude may be due in part to the average clinician’s unfamiliarity with the physical and biological basis of infrared imaging. The other methods of cancer investigations refer directly to topics of medical teaching. For instance, radiography and ultrasonography refer to structural anatomy. Infrared imaging, however, is based on thermodynamics and thermokinetics, which are unfamiliar to most clinicians; though man is experiencing heat production and exchange in every situation he undergoes or creates.
Considering the contribution that infrared imaging has demonstrated thus far in the field of early breast cancer detection, all possibilities should be considered for promoting further technical, biological, and clinical research along with the incorporation of the technology into common clinical use.

Refrences:

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Source:
Medical Infrared Imaging by Nicholas A. Diakides & Joseph D.
Bronzino. CRC Press, Taylor & Francis Group.