Braster

Opinion on usefulness of a medical device “BRASTER System of Home Prophylaxis of Breast Cancer”

The Polish Society of Gynecologists and Obstetricians was founded in 1922. It is a national scientific and professional association of obstetricians and gynecologists, including over 100 professors. The main idea behind the Society is to gather the best specialists in the field of gynecology, enabling them to exchange experiences, develop and analyze cases, and explore knowledge. In Poland, one of the tasks of gynecology as a scientific field and medical specialization is to provide medical care for women. This care includes health education, prophylaxis, diagnostics, and treatment.

Expert opinion of the Polish Society of Gynecologists and Obstetricians on the usefulness of the medical device “Braster In-home Breast Examination System”.

Breast cancer is the most common malignancy in women in Poland. In recent years, the number of new cases of this cancer has exceeded 16,500 per year and is estimated to increase to 20,000 over the next few years. Breast cancer is also the second leading cause of cancer death in women, preceded only by lung cancer. In Poland, approximately 5,500 women die from this cancer each year, and its standardized mortality rate is 14.5/100,000 [1,2]. Breast cancer is not only a huge social problem in Poland, it is also a considerable burden on healthcare systems throughout the world.

The main positive predictor for treatment outcome in breast cancer is its sufficiently early detection. In accordance with the guidelines of most scientific societies, it is recommended to perform population screening for breast cancer on the basis of mammographic examinations, which are the best method of early detection of this neoplasm. Properly planned screening should cover a large part of the population of women aged 50–69 years. Nevertheless, no consensus has been reached as to how often mammography should be performed. In the United States, most scientific societies recommend annual performance of mammography – only the American Cancer Society recommends mammography in women over 55 years of age at two-year intervals [3, 4, 5]. In Europe, all scientific societies recommend mammography every 2 years [6]. In most guidelines, it is not recommended to perform routine mammographic screening on women below 50 years of age, and in this age group the decision to perform this examination should be personalized. It is also not recommended to perform routine ultrasound examinations or magnetic resonance imaging (MRI) of the breasts, because those imaging methods may generate a large percentage of falsely positive results without simultaneously increasing the efficacy of screening. As for thermography, it is noted in the guidelines of most scientific societies that so far there have been no results from adequately planned research studies that would evaluate the usefulness of this method as a screening tool in breast cancer prophylaxis. Results of the existing studies evaluating the usefulness of thermography in breast cancer diagnostics are inconclusive. This arises mainly from numerous methodological errors in the design of those studies. Additionally, the studies published so far investigated only the method of remote (infrared) thermography, which gives results that are very difficult to interpret, generating a high percentage of inconclusive results that limit the usefulness of this method [7, 8].

The medical device Braster In-home Breast Examination System submitted for evaluation uses an innovative technology of contact thermography. Contact thermography is a fully non-invasive method of functional imaging testing of the examined organ. This method uses the so-called dermothermal effect, which makes it possible to record biothermal processes that occur in the observed organs inside the body from the surface of the skin. It is known that cancer cells, including breast cancer cells, are characterized by an increased metabolic rate. Additionally, a dense network of capillary vessels is being created within the neoplastic tumor, which leads to the formation of hyperthermal sites (with elevated temperature) that can be registered on the surface of the examined organ as the so-called thermal marker of the neoplastic lesion. Pathological lesions within the breast suspected for the presence of malignancy have a higher temperature than healthy sites and are visible on thermograms as colorful areas.

The bases for the present opinion are the results of the ThermaALG study (BRA/11/2014) and the results of our own observations made after an analysis of data obtained from 50 women who have used the Braster System for 12 weeks [9]. The ThermaALG study is the first prospective study in the world assessing the method of contact thermography according to the currently valid diagnostic standards of breast diseases. The study included 274 women aged 25 to 83 years, who were divided into two groups: women below 50 years of age (50-) and women above 50 years of age (50+). The results of that study evidenced higher usefulness of the Braster System in detection of potential breast lesions in women in the 50- group in comparison with the older women in the 50+ group. In women below 50 years of age, in whom an abnormal result of breast ultrasound and a positive result of the thermographic examination of the breast (presence of hyperthermal areas) was obtained, the risk of breast cancer development was twice as high in comparison with the group of patients with an abnormal result of breast ultrasound and a negative result of the thermographic examination of the breast (no hyperthermal areas). The authors of that study concluded that the contact thermography method might be a valuable method used for verification of abnormal results of an ultrasound examination of the breasts in women below 50 years of age. In the future, inclusion of this method in the diagnostic algorithm of breast disorders will hopefully reduce the still very high percentage of falsely positive results obtained in the ultrasound examination. During the ThermaALG study, no side effects associated with the use of the contact thermography method (Braster System) were found.

The results of our own observations based on the assessment of data collected from 50 women using the Braster System for 12 weeks also did not evidence any side effects of the use of this medical device. Women assessed the Braster System as a very friendly and comfortable method of breast self-control in the home setting.

In conclusion, on the basis of the observational and patient satisfaction studies conducted so far, the contact thermography method used in the Braster System is complementary to such examinations as X-ray mammography or breast ultrasound. In the future, this method may potentially become an adjunctive diagnostic tool in the protocol of prophylactic examinations for breast cancer. Currently, in the absence of clear guidelines for breast cancer screening in women below 50 years of age, this method combined with an ultrasound examination of breasts may constitute an interesting diagnostic algorithm for breast diseases. Nevertheless, it is necessary to conduct subsequent clinical trials in sufficiently large populations of women to be able to unequivocally determine the possibilities of using this method in the breast cancer screening program.

References:

1. Breast Cancer. Estimated Incidence, Mortality and Prevalence Worldwide in 2012. http://globocan.iarc.fr/old/FactSheets/cancers/breast-new.asp

2. Wojciechowska U, Olasek P, Czuderna K, Didkowska J. Cancer in Poland in 2014. Krajowy Rejestr Nowotworów. Warszawa 2016

3. Lee CH, Dershaw DD, Kopans D, Evans P, Monsees B, Monticciolo D, Brenner RJ, Bassett L, Berg W, Feig S, Hendrick E, Mendelson E, D’Orsi C, Sickles E, Burhenne LW. Breast cancer screening with imaging: recommendations from the Society of Breast Imaging and the ACR on the use of mammography, breast MRI, breast ultrasound, and other technologies for the detection of clinically occult breast cancer. Journal of the American College of Radiology 2010;7(1):18–27.

4. Wilt TJ, Harris RP, Qaseem A; High Value Care Task Force of the American College of Physicians. Screening for cancer: advice for high-value care from the American College of Physicians. Annals of Internal Medicine 2015;162(10):718–725.

5. Committee on Practice Bulletins – Gynecology. Breast Cancer Risk Assessment and Screening in Average-Risk Women. The American College of Obstetricians and Gynecologists Practice Bulletin. Number 179, July 2017.

6. Sardanelli F et al. Position paper on screening for breast cancer by the European Society of Breast Imaging (EUSOBI) and 30 national breast radiology bodies from Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Israel, Lithuania, Moldova, The Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Switzerland and Turkey. Eur Radiol (2017) 27:2737–2743 DOI 10.1007/s00330-016-4612-z

7. Sforza M, Ballerini A, Russo R, Carzaniga PL, Vertemati G. Contact thermography in breast pathology. A critical review. Minerva chirurgica 1991;46.8:375-7.

8. Bothmann G. Liquid crystal thermography of the breast. European Journal of Gynaecological Oncology 1986;7:88-92.

9. Liquid crystal thermography in breast cancer detection. Diana Hodorowicz-Zaniewska, Agnieszka Kotlarz, Piotr Kasprzak, Jan Skupień, Anna Ćwierz, Wojciech Rudnicki, Tadeusz J. Popiela, Paweł Basta. In press.

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