Optical Scatter Imaging System for Surgical Specimen Margin Assessment during Breast Conserving Surgery

 描述(申请人提供)：保乳手术是为局部乳腺癌提供的常规手术，但存在一个已知的问题，即是否整个癌症都已被切除。今天，大约三分之一的患者被召回进行第二次切除，因为当在第一次手术后的几天进行病理分析时，在标本表面或其周围1-2毫米范围内发现了残留的癌或DCIS。需要一种准确的外科医生辅助设备，它可以确定切除的标本在边缘没有癌症的可能性。这可以通过一个技术解决方案直接解决，该解决方案针对广域和体积扫描进行了优化，再加上计算机辅助决策。在这一学术和行业合作关系中，广域光学散射光谱成像与标本的体积CT扫描相结合，将PerkinElmer团队的大量临床前经验与达特茅斯团队的大量原型和临床标本成像工作整合在一起。散射成像允许通过对组织的高空间频率成像来进行表面扫描，这否定了来自组织表面的血液、液体或墨水的错误信号，这对于大组织领域的快速原位成像至关重要。这将与集成显示软件中的快速体积CT成像相结合。表面分子结构特征是外科医生识别潜在癌症区域的关键，体积CT也是关键，它可以识别在乳房X光检查中看到的癌症内部轨迹，并可用于帮助识别标本的哪些面最接近内部病变。联合系统将在最初几年内完成，并对来自乳腺病变组织库的已知组织样本的训练数据集进行测试。验证后，将在该系统上进行预期试验，以帮助确定保证金识别的准确性。总而言之，这将是第一批在单个组件中进行体积和表面扫描的综合方法之一，来自两个在癌症成像和系统开发方面具有丰富经验的小组。

 DESCRIPTION (provided by applicant): Breast conserving surgery is routinely offered for localized breast malignancies, but has a known problem of uncertainty about if the entire cancer has been removed. Today, approximately one third of all patients are recalled for a second re-excision because either residual cancer or DCIS was found on the specimen surface or within 1-2 mm of it, when analyzed in pathology in the days after the initial procedure. There is a need for an accurate surgeon assist device, which can determine the potential that the resected specimen is clear of cancer at the margins. This can be directly solved through a technological solution which is optimized for wide- field and volumetric scanning, coupled with computer-aided decision making. In this academic-industry partnership, wide-field optical scatter spectroscopic imaging is coupled to volumetric CT scanning of specimens, in a package which integrates a substantial pre-clinical experience by the PerkinElmer team, with substantial prototyping and clinical specimen imaging work of the Dartmouth team. Scatter imaging allows surface scanning through high-spatial frequency imaging of the tissue, which negates erroneous signals from blood, fluid or ink on the tissue surface, which is critically important for fast in situ imaging o large tissue fields. This will be coupled with fast volumetric CT imaging in integrated display software. The surface molecular- structural features are key to identifying potential cancer regions for the surgeon, as is the volumetric CT key to identifying the internal tracks of the cancer which were seen on mammography and can be used to help identify which faces of the specimen are closest to the internal lesion. The combined system will be completed in the first few years, and tested for training data sets on known tissue samples from the breast lesion tissue bank. Following validation, a prospective trial will be carried out on the system, to help determine the accuracy in margin identification. Taken together this will be one of the first comprehensive approaches to volumetric and surface scanning in a single package, and comes from two groups with substantial experience in the aspects of cancer imaging and system development.