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

项目总结/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%的乳房肿瘤切除术患者 在初次手术中，在瘤床中留下未识别的肿瘤。这个残留的肿瘤只有在 当病理学家在手术后评估切除边缘并发现阳性边缘时。大多数 切缘阳性的患者（~87%）需要进行第二次手术，这沿着增加了医疗保健费用， 患者焦虑和不适。为了解决这一未满足的需求，Lumicell开发了一种术中成像技术， 由分子成像剂（LUM 015）组成的系统，在被癌症激活后发射荧光 相关的酶，一个紧凑的手持成像头（LUM 2.6设备），捕捉荧光 发射检测和显示浸润性癌（80%的乳腺癌）的试剂和软件 例），以实时指导外科医生。我们在马萨诸塞州总医院， 根据FDA批准的IDE在乳腺癌患者中进行的可行性研究。可行性研究的第一部分已 在15例患者中未观察到不良事件。可行性研究的初步结果显示， 无假阴性（100%灵敏度），假阳性约为10%。在这项研究中，一种用于检测 发展出小得多的导管原位癌（DCIS; 20%的乳腺癌病例）病灶。为 该项目的第一个目标是开发和实施实时检测DCIS的软件。的 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申请， LUM成像系统的有效性。该研究的主要终点是阳性边缘率的降低 对于使用LUM成像系统的手术与乳腺标准护理（SOC）治疗 接受保乳乳房肿块切除术的癌症患者。次要终点是降低 当使用LUM成像系统时，研究的两个分支将 由对照组和器械组组成。对照组将包括100名患者，而器械组将 包括300名病人。在对照组中，患者将接受常规乳房肿瘤切除术。在设备中 组中，患者将接受常规乳房肿瘤切除术，然后对乳房肿瘤切除术腔成像， LUM成像系统将从LUM区域移除额外的治疗性腔刮除物 成像系统确定包含癌症。

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.