Early Screening of Breast Lesion Trial (Phase III Pivotal)

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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 (Tamoxifen, 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 >2 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 improvement. 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 changes 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 angiogenesis, 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 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 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.