Breast tumor detection using piezoelectric fingers: first clinical report.

Background: Mammography is key to detection of breast cancer in high-risk populations. Currently, aside from palpation and risk-assessment questionnaires, there is no prescreening test that can improve the accuracy, safety, and cost effectiveness of screening low-risk populations. The piezoelectric finger (PEF) is a radiation-free, portable, and low-cost breast tumor detector we developed to be used as a prescreening tool.

Study Design: Patients presenting with breast abnormalities detected by palpation or imaging were enrolled in this IRB-approved study. The PEF testing was performed with the patient in supine position before undergoing biopsy or surgical excision. The locations of the lesions detected by PEF were compared with those confirmed on imaging or pathology.

Results: A total of 40 patients were enrolled and 46 lesions were confirmed by imaging or pathology. The PEF reported 55 lesions, with 9 false positives and 2 true positives not originally found on imaging or palpation. The overall sensitivity of the PEF test was 87% (40 of 46). In women 40 years old or younger, overall sensitivity was or 100% (19 of 19). In women who had a lesion visible on mammography, PEF had a sensitivity of 83% (24 of 29). Of these, in women aged 40 years or younger, PEF identified all 7 mammographically visible lesions, including 2 malignant lesions. When compared with ultrasound, PEF correctly identified 87% (34 of 39) in this group. Of these, in women aged 40 years or younger, PEF identified 100% (19 of 19) of all ultrasound-visible lesions.

Conclusions: The PEF identified abnormalities in all 39 patients who presented with breast abnormalities and did not demonstrate any false negatives that would prevent the patients from additional evaluation, which makes it a good prescreening tool. In addition, PEF demonstrated 100% sensitivity in women aged 40 years or younger, a traditionally low-risk population.