Background Proliferative changes in breast epithelium are an intrinsic
aspect in the development of breast cancer, and result in regions of
epithelial electrical depolarisation within the breast parenchyma, whi
ch can extend to the shin surface. Diagnostic information might be obt
ained from a non-imaging and non-invasive test based on shin-surface e
lect ro potentials. Methods In 661 women, scheduled for open biopsy at
eight European centres, we studied whether measurements of breast ele
ctrical activity with surface sensors could distinguish benign from ma
lignant breast disease. A depolarisation index was developed. Results
We found a highly significant trend of progressive electrical changes
according to the proliferative characteristics of the biopsied tissue.
Discriminatory information was obtained in both premenopausal and pos
tmenopausal women, and the index was not related to age. The best test
performances were for women with palpable lesions. The median index w
as 0.398 for nonproliferative benign lesions, 0.531 for proliferative
benign lesions, and 0.644 for cancer (ductal carcinoma-in-situ and inv
asive). A specificity of 55% was obtained at 90% sensitivity for women
with palpable lesions when a discriminant based on age and the depola
risation index was used. Interpretation This new modality may have dia
gnostic value, especially in reducing the number of unnecessary diagno
stic tests among women with inconclusive findings on physical examinat
ion. Understanding and control of the biological variability of these
electrical phenomena will be important in the improvement of this test
. Studies in populations with a lower cancer prevalence are needed to
assess further the diagnostic value of this approach.