Early Screening of Breast Lesion Trial (Phase III Pivotal)

DESCRIPTION (provided by applicant): This amended trial (prior score 194) combines the experience and intellectual property of 3 NCI-funded Optical Breast Cancer groups, and proposes an early-detection cancer trial. With rare treatment exceptions (Tamoxife n, Herceptin), the long-term stage-specific mortality after breast cancer diagnosis has not appreciably changed in 50 years. In fact, the average breast tumor measures gt2 cm at diagnosis in the U.S. In contrast to conventional radiology wisdom that micro- calcifications and other features have routinely led to sub-millimeter diagnosis of breast cancer, many breast tumors (30%) are still only found by pain, discharge, and palpation, especially in the young, dense breast. This leaves large room for improvemen t. In NCI-funded work, consortium PI's exceeded all aims, confirmed that early breast/colon cancers are optically detectable based upon features correlated to pathology (cellularity, angiogenesis) and function (local metabolism), and that age-related chang es can be corrected for. Results of NCI-funded trials showed: The specific aims of this Clinical Trial Fast-Track for R43 Aims are: Aim 1: To reduce to manufacture a commercial-grade non-imaging spectroscopic breast scanner, sensitive to an giogenesis, cellularity, and metabolism, under FDA-design control and software requirements. If this device meets performance specifications, then the 3-year R44 aims are: Aim 1: To expand the pre-submission Pilot Trial into a NIH- defined Phase III pivota l 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 2: To submit and obtain FDA approval under 510(k) with clinicals or PMA status under this funding. The goal of this proposal is to bring a specific breast cancer screening device past FDA approval to market, just as applicant P.I. has successfully brought 2 prior optical technologies to approval and market.