Near Infrared Technology for the Detection of Cancer

The proposed study will introduce new hardware and software to an existing prototype imaging system to allow for real-time nonlinear reconstruction of functional volumetric images of the breast using near-infrared optical sources. In preliminary studieswe have shown the basic approach of dynamic optical tomography (DYNOT) to exhibit excellent sensitivity to well-known functional disturbances in tumor perfusion and disturbances in the balance in tissue oxygen supply/demand. These anomolies serve as thebiological markers for the presence of malignant tumor growth. We hypothesize that the sensitivity of the technique can be further improved by incorporating a new design to the measuring head to allow for simultaneous bilateral monitoring. To accommodatethe additional measuring sites, we will also introduce and integrate additional sensing hardware. The cost of this update will initially be cost-shared during the Phase I study. Further integration and purchase of the hardware in preparation for a PhaseII study is proposed during the Option period. A second aim of the study is to evaluate a new nonlinear reconstruction method based on the analysis of relative measures. This technique introduces a novel approach to improve image resolution and accuracyand considers frequency encoding of spatial information. The newly introduced capabilities will be evaluated on a minimum of twenty volunteers (10 healthy, 10 cancer). The proposed project builds on the growing success of NIRx to apply time-seriesoptical tomography for the investigation of functional disturbances in 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 withoutthe need for exposure 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 adifferential response. This would serve to expand the overall utility of the imaging technology that continues to gain acceptance as a powerful new functional imaging method. We estimate that the commercial potential of our technology as ageneral-purpose research imager is on the order of 300 units @ 200K/unit within the next four years. The market size for clinical applications related to breast cancer evaluation is considerably larger and would involve sales of lower cost systems(80-100K/unit). Larger still is the overall clinical market (i.e., neonatal monitoring, peripheral vascular disease, pharmaceutical evaluation, cerebral vascular monitoring, muscle disorders, autonomic disease, etc.) for which we are identifying newapplications on a regular basis.