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

LUM 成像系统的一项前瞻性、多中心关键研究，用于保乳手术中实时体内边​​缘评估

• 批准号: 9200487
• 负责人: W David Lee
• 金额: $ 103.31万
• 依托单位: LUMICELL, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-04 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9200487
• 关键词: Academic Medical Centers; Address; Adoption; Adverse event; Algorithms; Anxiety; Beds; Breast; Breast Cancer Patient; Breast-Conserving Surgery; Carcinoma; Caring; Characteristics; Clinical; Clinical Research; Clinical Trials; Computer software; Data; Detection; Devices; Diagnosis; Enzymes; Epidemic; Excision; FDA approved; Feasibility Studies; Fluorescence; General Hospitals; Hand; Head; Health Care Costs; Hour; Image; Image Analysis; Imaging Device; Institution; Label; Left; Malignant Neoplasms; Marketing; Massachusetts; Measures; Microscopic; Morbidity - disease rate; Morphology; Noninfiltrating Intraductal Carcinoma; Operative Surgical Procedures; Pathologist; Patients; Phase; Postoperative Period; Procedures; Randomized; Repeat Surgery; Reporting; Residual Cancers; Residual Tumors; Residual state; Safety; Site; Small Business Innovation Research Grant; Statistical Data Interpretation; Surgeon; System; Techniques; Technology; Testing; Therapeutic; Thick; Time; abstracting; arm; base; breast lumpectomy; cancer cell; cancer imaging; cancer surgery; efficacy trial; expedited review; imaging agent; imaging modality; imaging system; improved; in vivo; intraoperative imaging; malignant breast neoplasm; meetings; molecular imaging; novel; prospective; prototype; safety study; sarcoma; software systems; standard of care; tumor; verification and validation

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, more than 30% 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 one week later 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. Our collaborators 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, Lumicell developed an approach for detecting the much smaller foci of ductal carcinoma in situ (DCIS; 20% of breast cancer cases). As the first aim of this proposal, we will develop and implement software for real- time detection of DCIS. Our next proposed 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 positives 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 due to positive margins when the LUM Imaging System is used. The device arm will consists of 300 patients, while the control (SOC) arm will consists of 100 patients. In the SOC arm, patients will undergo a routine lumpectomy procedure. In the device arm, patients will undergo SOC treatment followed by imaging of the lumpectomy cavity with the LUM Imaging System. Additional therapeutic cavity shaves will be removed from regions that Lumicell's detection algorithm determines to contain cancer.

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，超过30%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 当病理学家在一周后评估切除边缘并发现阳性边缘时发现。 大多数切缘阳性的患者（~87%）需要进行第二次手术，这增加了医疗保健 伴随着患者的焦虑和不适而沿着付出代价。为了满足这一未满足的需求，Lumicell开发了一种 由分子成像剂（LUM 015）组成的术中成像系统，在 激活的癌症相关酶，一个紧凑的手持成像头（LUM 2.6设备），捕捉 检测和显示浸润性癌的试剂和软件的荧光发射（80%的 乳腺癌病例）来实时指导外科医生。我们在马萨诸塞州总医院的合作者 医院正在根据FDA批准的IDE在乳腺癌患者中进行可行性研究。第一部分 的可行性研究已经完成，在15名患者中未观察到不良事件。初步成效 可行性研究的结果显示，没有假阴性（100%灵敏度），假阳性率约为10%。在此 Lumicell研究开发了一种检测导管原位癌（DCIS; 20%的乳腺癌病例）。作为本提案的第一个目标，我们将开发和实施真实的软件- DCIS的时间检测。我们的下一个目标是进行一项双臂、多机构的关键性临床试验，以支持 我们的PMA申请，以衡量LUM成像系统的有效性。研究的主要终点是 与标准相比，使用LUM成像系统的手术的阳性边缘率降低 对接受保乳乳房肿块切除术的乳腺癌患者进行护理（SOC）治疗。的 次要终点是当LUM 使用成像系统。器械组将由300名患者组成，而对照（SOC）组将由 100个病人。在SOC组中，患者将接受常规乳房肿瘤切除术。在器械臂中， 患者将接受SOC治疗，然后使用LUM成像对乳房肿瘤切除术腔进行成像 系统将从Lumicell的检测算法 决定遏制癌症。