It has been known for some time that many tumors have a significantly different conductivity and permittivity from surrounding normal tissue. This high ldquocontrastrdquo in tissue electrical properties, occurring between a few kilohertz and several megahertz, may permit differentiating malignant from benign tissues. Here we show the ability of electrical impedance spectroscopy (EIS) to roughly localize and clearly distinguish cancers from normal tissues and benign lesions. Localization of these lesions is confirmed by simultaneous, in register digital breast tomosynthesis (DBT) mammography or 3-D mammograms.

Two randomized trials were conducted in Canada in the 1980s to test the efficacy of breast cancer screening. Neither of the trials demonstrated benefit. Concerns were raised regarding serious errors in trial design and conduct. Here we describe the conditions that could allow subversion of randomization to occur and the inclusion of many symptomatic women in a screening trial. We examine anomalies in data where the balance would be expected between trial arms. “Open book” randomization and performance of clinical breast examination on all women before allocation to a trial arm allowed women with palpable findings to be mis-randomized into the mammography arm. Multiple indicators raising suspicion of subversion are present including a large excess in poor-prognosis cancers in the mammography trial arm at prevalence screen. Personnel described shifting of women from the control group into the mammography group. There is compelling evidence of subversion of randomization in Canadian National Breast Screening Study. Mis-randomization of even a few women with advanced breast cancer could markedly affect measured screening efficacy. The Canadian National Breast Screening Study trials should not influence breast screening policies.