Spectroscopic Localization of Breast Cancer

DESCRIPTION (provided by applicant): This Multi-Center Phase II R44 Competing Renewal addresses the late diagnosis of breast cancer. With rare treatment exceptions (such as Tamoxifen and Herceptin), the long-term stage-specific mortality after breast cancer diagnosis has not appreciably changed over the past 50 years. Recently, many have concluded that the single major factor in improved survival in breast cancer has been a shift toward earlier diagnosis. Despite this, the average breast tumor currently measures 2.3 cm across in the U.S. at diagnosis. In contrast to conventional wisdom that micro-calcifications and other features have led to sub- millimeter diagnosis of breast cancer, many breast tumors (30%) are still only found by pain, discharge, and palpation rather than by radiological screening programs. This leaves a large margin for improvement. In the prior R44, we met all R44 aims, and confirmed our hypothesis that early colon and breast cancers are optically detectable. Results of the prior R44 Pilot Clinical Trials are as follows: The specific aims of this Phase II (R44) continuation proposal are: Aim 1: To manufacture a commercial-grade non-imaging spectroscopic breast scanner, sensitive to angiogenesis and cellularity, under FDA-design control and software requirements; Aim 2: To expand the pre-submission Pilot Trial into a NIH-defined Phase III pivotal trial of the FDA-submitted device enrolling a statistically-justified minimum of 500 patients at 3 centers over 36 months under GLP standards, sufficient for FDA submission, and Aim 3: To submit and obtain FDA approval under 510(k) with clinicals or PMA status during this competing renewal.