The sensitivity of iSense Medical Corp (IMC) sensor system for the detection of a lung cancer signature from breath will be enhanced and demonstrated, a new breath collection device completed and a modification of the Cleveland Clinic Foundation (CCF) protocol for the ELDDA study of 8000 lung cancer patients and controls will be completed. The first generation of this non-invasive, inexpensice and rapid assay for the presence of lunf cancer has already been tested at CCF wwith specificity and selectivity of detection in the 80s. The next generation of this sensor array,comprising optical indicators embedded in a nanoporous sol-gel matrix is now>100x more sensitive to a range of lung cancer breath markers, enhancing sensitivty for a breast sensor technology already proven effective in lung cancer detection. The approved CCF protocol will be refined to assess the specific claim that following an indeterminate lung CT witht he IMC breath test reduces lung cancer diagnosis false positives over 200%. Further, as lung cancer breath signature arises from active tumor metabolism, the protocol will be adapted to test the hypothesis that the IMC breath rest represents a rapid and low-cost assessment for the efficacy of chemotherapy.
