New clinical research shows that a noninvasive test, the Breast Biophysical Examination (BBE), may help physicians more effectively detect breast cancer, as well as identify women who do not have cancer. The research, funded in part by the National Cancer Institute, was presented at the 17th Annual San Antonio Breast Cancer Symposium.
"These studies indicate that the BBE has the potential to help physicians more effectively diagnose breast cancer," says Joseph P. Crowe, Jr., MD, Director of Breast Services at The Cleveland Clinic Foundation, and the study's lead investigator.
Each year, physical examination and mammography identify suspicious lesions in millions of women, the vast majority of whom do not have cancer. Yet many of these women will undergo an extensive diagnostic workup involving multiple tests, such as diagnostic mammography or fine needle aspiration. The next step for many of these women is surgical biopsy, which can cost up to $4,500 per procedure. According to the National Cancer Institute, 182,000 new breast cancers will be diagnosed in 1995 from an estimated 750,000 surgical biopsies.
"Most of the abnormalities found through screening are benign," notes Dr. Crowe. "Therefore, an important criterion for any new diagnostic test is that it accurately identify those patients who do not have cancer. In this way, additional diagnostic tests, and open biopsy, can be reserved for those patients most likely to benefit. This would improve the efficiency of the diagnostic process, and also significantly decrease the number of unnecessary biopsies."
The BBE technology is based on the fact that all cells have electrical charges; however, cancerous tissue contains cells that have different electrical properties than benign or normal tissue. The BBE noninvasively measures the electrical differentials between cancerous and benign tissue using specially designed sensors placed on the skin.
Dr. Crowe presented data on 457 women who participated in the research. Of these, 392 had breast lesions previously detected through physical examination or mammography, and were already scheduled for surgical biopsy. These patients were tested with the BBE device before going to biopsy. In order to study the test in women believed not to have breast cancer, an additional 65 patients who had no previously identified lesions were also included in the study. They were tested using the BBE, but no biopsy was performed subsequently.
The combined results of the two studies presented by Dr. Crowe demonstrated 98% sensitivity, identifying cancer in 178 of the 182 patients with cancer; and 86% specificity, indicating no cancer at all in 181 of the 210 patients without cancer.
"The results of our study indicate that the BBE could be an important tool in breast cancer diagnosis. It is simple to administer, does not involve x-rays or image interpretation, and provides an objective result in approximately 20 minutes. Additionally, this technology may have the potential in the future to be used as a screening test," adds Dr. Crowe.
The BBE device is being developed by Biofield Corp. of Roswell, Georgia.