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

 描述（由申请人提供）：保乳手术通常用于局部乳腺恶性肿瘤，但已知的问题是不确定是否已切除整个癌症。今天，大约三分之一的患者被召回进行第二次再次切除，因为在初次手术后的几天内进行病理学分析时，在标本表面或其1-2 mm范围内发现了残留癌或DCIS。需要一种精确的外科医生辅助装置，其可以确定切除的标本在边缘处没有癌症的可能性。这可以通过针对宽场和体积扫描进行优化的技术解决方案以及计算机辅助决策来直接解决。在这个学术界和工业界的合作伙伴关系中，宽场光学散射光谱成像与标本的体积CT扫描相结合，在一个包中集成了PerkinElmer团队的大量临床前经验，以及达特茅斯团队的大量原型和临床标本成像工作。散射成像允许通过组织的高空间频率成像进行表面扫描，这消除了来自组织表面上的血液、流体或墨水的错误信号，这对于大组织野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，因为体积CT是识别乳房X线摄影上看到的癌症内部轨迹的关键，并且可以用于帮助识别样本的哪些面最接近内部病变。该组合系统将在最初几年完成，并在来自乳腺病变组织库的已知组织样本上测试训练数据集。验证后，将对系统进行前瞻性试验，以帮助确定边缘识别的准确性。总之，这将是第一个全面的方法，体积和表面扫描在一个单一的包，并来自两个小组在癌症成像和系统开发方面的大量经验。

 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.