Electrical Impedance Imaging of the Breast: Correlation with MRI, US, Sestamibi, and Histology With Measures of Cell Proliferation and Vascular Density

摘要

This project was designed to test a new method for the evaluation of lesions suspected as possible cancers after their initial detection. Electrical Impedance Imaging (EII) is a novel method for the evaluation of breast lesions that relies on measurements of the electrical impedance and capacitance of breast tissues. It showed, in previous trials, good ability to distinguish benign and malignant lesions. The system received FDA approval 4116/99. The work on this project was delayed because we have not yet received approval from the U.S. Army to start the clinical trial. New information also indicates the need for protocol modification and we have submitted the new protocol for approval. Because the system is FDA approved, we have been using it both clinically and in other clinical trials and have discovered that the system is not ready for the type of use originally proposed. The main problem is that the system has a very large number of false positive findings, that is findings that are positive by EII criteria, but are not cancer. In some breasts four or more such false positives can be found.