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
"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.