Clinical data from the initial study of the BreastAlert Differential Temperature Sensor support its usefulness for indicating the possibility of heat-emitting, medically significant breast disease, including cancer. The noninvasive device will be available to physicians from HumaScan Inc (Cranford, New Jersey) by mid-1997.

The clinical paper was written by medical experts with assistance from IDEAMed, a wholly owned technology and clinical research service of the University of Virginia Health Services Foundation, and has been submitted for peer-review journal publication.

"Prior to initiating additional prospective clinical trials, we find it informative to learn as much as possible about the performance characteristics of the BreastAlert Differential Temperature Sensor," states David Martin, phd, Executive Director of IDEAMed and Assistant Professor of Radiology at the University of Virginia. "We feel that HumaScan will gain new information which will refine and focus the scope of the future, multi-site clinical trials and additional technology evaluations in early 1997."

When early-stage breast cancer is present, metabolic activity increases, producing excessive heat, which most often escapes at the surface of the breast. The BreastAlert device records skin temperatures on three large areas of each breast, with an average temperature differential of 2 °F or more between three large mirror image segments alerting the physician to possible underlying breast disease in need of further examination.

Device Intended to Complement Clinical Breast Examination

Based on the initial evaluations of the clinical data, Martin and colleagues believe that the BreastAlert device, a 15-minute test, may provide a valuable adjunctive tool for alerting gynecologists and primary-care physicians to the possibility of underlying breast disease. As a complement to physical clinical breast examination, the product is designed to improve the chances of detecting fast-growing, heat-emitting active tumors in the intervals between mammographic screenings or when mammography is not indicated by screening guidelines for women under 50 years of age.

Device May Be of Particular Value in Women Under Age 50

HumaScan president and CEO Donald Brounstein points out, "BreastAlert Differential Temperature Sensor may be especially appropriate for younger women under 50 whose denser breast tissue makes it more difficult for mammography to pick up suspicious lesions. This product provides a 'red flag' to the physician just before clinical breast examination, as well as to the mammographer before the mammogram is performed, that a specific area of the breast needs particularly close examination."

Breast cancers tend to grow significantly faster in women under age 50. According to a study published in Cancer (71:3547-3551, 1993), the average tumor doubling time in women under age 50 is 80 days, as compared with 157 days in women 50 to 70 years old and 188 days in those over age 70.

"The faster a malignant tumor grows, the more heat it generates," adds Brounstein. "For younger women, in particular, results of the BreastAlert Differential Temperature Sensor test may lead to earlier detection and ultimately, longer life."

More than 90% of women diagnosed with early-stage cancer are alive 5 years later, and yet only 58% of cancers are diagnosed at this stage, according to the American Cancer Society. During a clinical breast examination, a physician must rely on palpation and eyesight to detect breast tumors, which, for women under age 50, may often occur when cancer is no longer localized or confined to the breast. The BreastAlert device can provide an alert just before clinical breast examination and possible referral to mammography so as to enhance early detection by the physician.