Near Infrared Technology for the Detection of Cancer

The proposed study will extend advances made during Phase I in hardware and software design to an existing real-time optical tomography system for the purpose of early breast cancer detection. In preliminary studies we have shown the basic approach ofdynamic optical tomography (DYNOT) exhibits excellent sensitivity to well-known functional disturbances in tumor perfusion and to disturbances in tissue oxygen supply/demand. These anomalies can serve as the biological markers for the presence ofmalignant tumor growth. The new system will provide for simultaneous bilateral imaging studies of the breast and incorporate a nonlinear image update scheme developed under Phase I support. Preliminary studies indicate that the new update scheme isrobust, highly efficient and applicable to a broad spectrum of inverse problems having commercial and military interest. Specific aims of this Phase II study include integration and testing of new hardware, upgrades to software modules includingadditional testing of the nonlinear scheme and expanded clinical trials to include studies on healthy women, those with benign breast pathology and cancerous tumors. The proposed project builds on the growing success of NIRx to apply time-series opticaltomography for the investigation of functional responses of the vascular bed of tissue for research and clinical studies. Successful demonstration of the proposed system could result in more rapid and reliable breast cancer screening without the need forexposure to ionizing sources or painful compression. Significantly, these capabilities can be extended to allow for simultaneous multi-site monitoring of other target tissues (e.g., limbs, head) for which there is a need to assess a differential response.This would serve to expand the overall utility of the imaging technology that continues to gain acceptance as a powerful new functional imaging tool. The commercial potential of our proprietary technology continues to expand with our increasingdemonstration of its general utility. Sizable markets (>$10 M) have already been identified for uses in neonatal monitoring, peripheral vascular disease, pharmaceutical evaluation, cerebral vascular monitoring, muscle disorders, and veterinary uses.Adding to this potential is the genuine interest expressed by established strategic partners who seek to aid in our specialized product development.