A prospective, multi-center pivotal study of the LUM Imaging System for real-time, in vivo margin assessment in breast conserving surgery

项目摘要/摘要 目前的术前和术中切缘评估技术不能充分指导乳腺癌 外科医生在保乳手术中切除所有癌症。因此，20%-40%的肿块切除术患者 在最初的手术中有未被识别的肿瘤残留在肿瘤床上。这个残留的肿瘤只被发现 当病理学家在手术后评估切除切缘并发现切缘阳性时。大多数人 利润率为正的患者(~87%)需要进行第二次手术，这增加了医疗保健成本 病人焦虑和不适。为了解决这一未得到满足的需求，Lumicell开发了一种术中成像 由分子显像剂(LUM015)组成的系统，该系统在被癌症激活后发出荧光 相关的酶，一个紧凑的手持成像头(Lum 2.6设备)，可以捕获荧光 检测和显示浸润性癌的试剂和软件的发射(80%的乳腺癌 病例)，以实时指导外科医生。我们在马萨诸塞州综合医院正在进行一项 在FDA批准的IDE下对乳腺癌患者进行可行性研究。可行性研究的第一部分有 均已完成，15例患者未观察到不良反应。可行性研究的初步结果表明 无假阴性(100%敏感性)，假阳性约10%。在这项研究中，一种检测 导管原位癌(DCIS；20%的乳腺癌病例)的病灶要小得多。作为 这项提议的首要目标是，该小组将开发和实施实时检测DCIS的软件。这个 第二个目标是一项双臂、多机构的关键临床试验，以支持我们的PMA应用程序来衡量 LUM成像系统的功效。这项研究的主要终点是降低正保证金比率 对于使用Lum成像系统的手术与标准护理(SOC)治疗的乳房 接受保乳肿块切除术的癌症患者。次要终点是速率的降低 当使用Lum成像系统时，第二次手术的利润率为正。这项研究的两个分支将 由控制臂和装置臂组成。控制臂将包括100名患者，而设备臂将包括 包括300名患者。在对照组，患者将接受常规的肿块切除术。在设备中 ARM，患者将接受常规的肿块切除程序，然后对肿块切除腔进行成像 Lum成像系统。将从隆起的区域移除额外的治疗性空洞剃须刀 成像系统确定要遏制癌症。

Project Summary/Abstract Current pre-operative and intraoperative margin assessment techniques fail to adequately guide breast cancer surgeons to remove all cancer during breast conserving surgeries. As a result, 20-40% of lumpectomy patients have unrecognized tumor left in the tumor bed during the initial surgery. This residual tumor is only discovered when the pathologist evaluates the resection margins after surgery and finds a positive margin. The majority of patients with positive margins (~87%) require a second surgery, which increases health care costs along with patient anxiety and discomfort. To address this unmet need, Lumicell has developed an intraoperative imaging system consisting of a molecular imaging agent (LUM015) that emits fluorescence after activation by cancer associated enzymes, a compact hand-held imaging head (LUM 2.6 Device) that captures the fluorescence emission of the agent and software that detects and displays invasive carcinomas (80% of the breast cancer cases) in real-time to guide the surgeon. We, at the Massachusetts General Hospital, are conducting a feasibility study in breast cancer patients under an FDA-approved IDE. The first part of the feasibility study has been completed with no adverse events observed in 15 patients. Initial results from the feasibility study show no false negatives (100% sensitivity) with ~10% false positives. During this study, an approach for detecting the much smaller foci of ductal carcinoma in situ (DCIS; 20% of breast cancer cases) was developed. As the first aim of this proposal, the team will develop and implement software for real-time detection of DCIS. The second aim is a two arm, multi-institution pivotal clinical trial in support of our PMA application to measure the efficacy of the LUM Imaging System. The primary endpoint of the study is the reduction in positive margin rates for surgeries in which the LUM Imaging System is used versus standard of care (SOC) treatment for breast cancer patients undergoing breast conserving lumpectomies. The secondary endpoint is a reduction in the rate of second surgeries for positive margins when the LUM Imaging System is used. The two arms of the study will consist of a control arm and a device arm. The control arm will include 100 patients, while the device arm will include 300 patients. In the control arm, patients will undergo a routine lumpectomy procedure. In the device arm, patients will undergo a routine lumpectomy procedure followed by imaging of the lumpectomy cavity with the LUM Imaging System. Additional therapeutic cavity shaves will be removed from regions that LUM Imaging System determines to contain cancer.