Background: One way to improve the cost-benefit ratio for breast cancer screening in younger women is to identify those at high-risk of breast cancer and manage them in an optimal manner. The purpose of this study is to evaluate the sensitivity and specificity of Electrical Impedance Scanning (EIS) for identifying young women who are at risk for having breast cancer and should be followed with directed imaging technologies.
Methods: A prospective, observational, two-arm, multi-site clinical trial was performed on women aged 30-45 years. The 'Sensitivity Arm' included Clinical Breast Examinations (CBE) and EIS (T-Scan 2000ED) on 189 women prior to scheduled breast biopsy. The 'Specificity Arm' included 1361 asymptomatic women visiting clinics for routine annual well-woman examination. Sensitivity and specificity were determined. Relative probability for a woman with a positive EIS examination was computed and compared with other approaches commonly used to define 'high-risk' in this population.
Results: Fifty of 189 women in the Sensitivity arm had verified cancers, 19 of whom had positive EIS examination resulting in sensitivity of 38% (19/50). Of the 1361 women in the Specificity arm, 67 had positive EIS examination resulting in a specificity of 95% (1294/1361). The relative probability of a woman with a positive EIS examination was 7.68, which compares favorably with other established risk identifiers (e.g. two first-degree relatives with breast cancer or atypical ductal hyperplasia).
Conclusion: EIS may have an important role as a screening tool for identifying young women that should be followed more closely with advanced imaging technologies for early detection of breast cancer.