Method and system for detecting electrophysiological changes in pre-cancerous and cancerous tissue and epithelium

Abstract

A method and system for determining a condition of a selected region of epithelial and stromal tissue, for example in the human breast. A plurality of electrodes are used to measure surface and transepithelial electropotential of breast tissue as well as surface electropotential and impedance at one or more locations and at several defined frequencies, particularly very low frequencies. An agent may be introduced into the region of tissue to enhance electrophysiological characteristics. Measurements made at ambient and varying suction and/or positive pressure applied to the epithelial tissue and/or positive pressure conditions applied to the breast are also used as a diagnostic tool. Tissue condition is determined based on the electropotential and impedance profile at different depths of the epithelium, stroma, tissue, or organ, together with an estimate of the functional changes in the epithelium due to altered ion transport and electrophysiological properties of the tissue. Devices for practicing the disclosed methods are also provided.

1 . A method for determining a condition of a region of epithelial or stromal tissue comprising:
 A. measurement of an impedance spectrum over a region of tissue where an abnormality is suspected (suspicious region);   B. measurement of an impedance spectrum over a region of tissue where no abnormality is suspected (control region);   C. application of mechanical pressure or compression over the suspicious region;   D. measurement of the impedance spectrum in the suspicious region following the application of mechanical pressure;   E. application of mechanical pressure or compression over the control region;   F. comparison of the impedance profile before and after compression in the suspicious region;   G. comparison of the impedance profile before and after compression in the control region; and   H. comparison of the impedance profile of the suspicious region to the control region.   
     
     
         2 . A computer-readable medium having computer-executable instructions for performing a method for determining the presence of a tumor in the human breast comprising:
 establishing a connection between a first electrode and a region of epithelial tissue within the duct of a breast;   establishing a connection between a second electrode on the surface of the breast;   establishing a signal between the first and second electrodes;   measuring an electrical property between the first and second electrode;   applying at least one form of pressure to at least one region of the breast, the form pressure selected from the group consisting of positive pressure, negative pressure and a combination of positive and negative pressure;   measuring an electrical property between the first and second electrode in response to the pressure; and   determining the presence of a tumor based on the signal, or the change in the signal in response to the pressure, between the first and second electrode.