Thermography is a diagnostic technique in which an infrared camera (also called digital infrared thermal imaging) is used to measure temperature variations on the surface of the body, producing images that reveal sites of abnormal tissue growth. Tumors may exhibit higher metabolic activity (manifested in heat and increased blood flow) and the increase in body temperature is suggested to be used to screen and diagnose breast abnormalities. An alternate method of thermography involves the placement of liquid crystal sheets directly onto the skin (eg, BreastCare/BreastAlert Differential Temperature Sensor).

Based on the evaluation of initial clinical data, the Food and Drug Administration has approved the BreastAlert Differential Temperature Sensor (Scantek Medical, Inc., Denville, NJ) for indicating the possibility of heat-emitting, medically significant breast disease, including cancer. The BreastAlert device consists of a pair of soft, lightweight pads that a woman wears inside her bra for 15 minutes while at the doctor's office as an adjunct to standard breast cancer screening. They record skin temperatures on 3 large segments of each breast. An averaged temperature differential of 2 degrees Fahrenheit or more between mirror-image segments alerts the physician to possible underlying breast disease in need of further examination.

As with thermography, there is a lack of evidence in the medical literature demonstrating an acceptable level of sensitivity and specificity in using the BreastAlert differential temperature sensor device as a physiologic imaging method for detecting a possible thermally active cancer. The clinical utility of this technique has not been compared to other readily available methods to screen for breast cancer. Well-designed clinical studies are needed to ascertain the diagnostic accuracy and clinical usefulness of the BreastAlert differential temperature sensor device.

Hoeg and associates (2021) noted that patient-reported outcomes (PRO) may facilitate prompt treatment. These researchers described the development and psychometric properties of the 1st instrument to monitor for symptoms of breast cancer (BC) recurrence. This study was nested in the MyHealth randomized trial of nurse-led follow-up based on electronically-collected PROs. These investigators constructed items evaluating symptoms of potential recurrence via expert interviews with 6 BC specialists in Denmark. Semi-structured cognitive interviews were performed with a patient panel to examine acceptability and comprehensibility. Items were subsequently tested in a population of 1,170 women 1 to 10 years after completing BC treatment. These researchers conducted multiple-groups confirmatory factor analysis (CFA) and Rasch analysis to test dimensionality, local dependence (LD) and differential item functioning (DIF) according to socio-demographic and treatment-related factors. Clinical data were obtained from the Danish Breast Cancer Group registry. A total of 21 items were generated for the Breast Cancer Recurrence instrument (BreastCaRe). Cognitive testing resulted in clearer items; 7 subscales based on general, bone, liver, lung, brain, loco-regional and contralateral recurrence symptoms were proposed. Both CFA and Rasch models confirmed the factor structure. No DIF was identified; 5-item pairs showed LD; but all items were retained to avoid loss of clinical information. Rasch models taking LD into account were used to generate a standardized scoring table for each subscale. The authors concluded that the BreastCaRe had good content and structural validity, patient acceptability and measurement invariance. These researchers are preparing to examine the predictive validity of this new instrument.

Scope of Policy

This Clinical Policy Bulletin addresses BreastCare/BreastAlert differential temperature sensor.

Experimental and Investigational

The BreastCare DTS device (Life Medical Technologies, Fishkill, NY), previously known as BreastAlert Differential Temperature Sensor device (HumaScan, Inc., Cranford, NJ), which has been used to detect cancer and other heat-emitting medically significant breast disease, is considered experimental and investigational because there is insufficient scientific evidence in the medical literature to support its routine use in clinical practice and the effectiveness of this device has not been established.