Early Screening of Breast Lesion Trial (Phase III Pivotal)

描述(由申请人提供)：这项修订后的试验(之前的分数为194)结合了3个NCI资助的光学乳腺癌组织的经验和知识产权，并提出了一项早期发现癌症的试验。除了罕见的治疗例外(他莫昔芬、赫赛汀)，乳腺癌诊断后的长期特定阶段死亡率在50年内没有明显变化。事实上，在美国，乳腺肿瘤诊断时的平均尺寸为2厘米。与传统的放射学智慧不同的是，微钙化和其他特征通常导致乳腺癌的诊断为亚毫米级，许多乳腺肿瘤(30%)仍然只能通过疼痛、分泌物和触诊才能发现，特别是在年轻、致密的乳房。这就留下了很大的改进空间。在NCI资助的研究中，Pi‘s财团超越了所有目标，证实早期乳腺癌/结肠癌可以根据与病理(细胞性、血管生成)和功能(局部新陈代谢)相关的特征进行光学检测，并且与年龄相关的变化可以纠正。NCI资助的试验结果显示： 这项针对R43目标的临床试验Fast-Track的具体目标是：目标1：在FDA的设计控制和软件要求下，减少对血管生成、细胞密度和新陈代谢敏感的商业级非成像光谱乳腺扫描仪的制造。如果该设备符合性能规格，则为期3年的R44目标是：目标1：将提交前的试点试验扩大到NIH定义的FDA提交的设备的第三阶段关键试验，根据GLP标准，在36个月内在3个中心招募至少500名患者，足以提交FDA，目标2：根据510(K)提交并获得FDA批准，在此资金下具有临床试验或PMA状态。这项提案的目标是将一种通过FDA批准的特定乳腺癌筛查设备推向市场，就像申请者P.I.成功地将两项先前的光学技术推向批准和市场一样。

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.