Early Screening of Breast Lesion Trial (Phase III Pivotal)

乳腺病变早期筛查试验（第三阶段关键）

• 批准号: 7664642
• 负责人: David A. Benaron
• 金额: $ 70.12万
• 依托单位: SPECTROS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-27 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7664642
• 关键词: Breast; Breast Cancer Detection; Cellularity; Clinic; Clinical Data; Clinical Trials; Colon Carcinoma; Computer software; Data; Data Analyses; Data Collection; Detection; Device Designs; Devices; Diagnosis; Diagnostic Neoplasm Staging; Early treatment; Enrollment; FDA approved; Funding; Goals; Hemoglobin; Image; Intellectual Property; Ischemia; Left; Lipids; Luciferases; Malignant neoplasm of prostate; Mammary Neoplasms; Marketing; Measures; Metabolism; Monitor; Optics; PSA screening; Pain; Palpation; Pathology; Patient observation; Patients; Performance; Phase; Phase III Clinical Trials; Publications; Radiology Specialty; Roche brand of trastuzumab; Safety; Screening for cancer; Screening procedure; Sensitivity and Specificity; Specificity; Spectrum Analysis; Staging; Sterility; System; Tamoxifen; Technology; Testing; United States National Institutes of Health; Water; Woman; Work; age related; angiogenesis; base; biomaterial compatibility; breast cancer diagnosis; breast lesion; breast scanner; calcification; design; experience; follow-up; improved; malignant breast neoplasm; meetings; men; millimeter; mortality; pilot trial; spectroscopic imaging

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.

描述（由申请人提供）：这项修改后的试验（先前评分 194）结合了 3 个 NCI 资助的光学乳腺癌小组的经验和知识产权，并提出了一项早期检测癌症试验。除了罕见的治疗例外（他莫昔芬、赫赛汀）之外，乳腺癌诊断后的长期分期死亡率在 50 年来没有明显变化。事实上，在美国，诊断时乳腺肿瘤的平均尺寸大于 2 厘米。传统放射学观点认为，微钙化和其他特征通常会导致亚毫米级乳腺癌诊断，但许多乳腺肿瘤 (30%) 仍处于诊断阶段。仅通过疼痛、分泌物和触诊发现，尤其是在年轻、致密的乳房中。这留下了很大的改进空间。在 NCI 资助的工作中，PI 联盟超出了所有目标，证实早期乳腺癌/结肠癌可以根据与病理学（细胞结构、血管生成）和功能（局部代谢）相关的特征进行光学检测，并且可以纠正与年龄相关的变化。 NCI 资助的试验结果显示： R43 临床试验快速通道的具体目标是： 目标 1：在 FDA 设计控制和软件要求下，减少制造对血管生成、细胞结构和代谢敏感的商业级非成像光谱乳腺扫描仪。如果该设备满足性能规格，则 3 年 R44 目标为： 目标 1：将提交前试点试验扩展到 NIH 定义的 FDA 提交设备的 III 期关键试验，招募统计上合理的至少 500 名患者根据 GLP 标准，在 3 个中心接受超过 36 个月的患者治疗，足以提交 FDA 申请，目标 2：根据 510(k) 提交临床或 PMA 状态并获得 FDA 批准资金。该提案的目标是将一种特定的乳腺癌筛查设备通过 FDA 批准推向市场，就像申请人 P.I. 一样。已成功将两项先前的光学技术推向审批并推向市场。