Spectroscopic Diagnostic for Barrett's Dysplasia

描述(申请人提供)：Barrett‘s食道(BE)是一种后天性的食道下段病变，正常的鳞状组织被化生的柱状粘膜所取代。BE本身不是恶性的，但它是食管腺癌的主要危险因素，而且相当数量的BE患者在第一次内窥镜检查时就会发生腺癌。目前，对不典型增生的检查需要大量随机的活检样本。这项工作将完成Barrett‘s发育不良检测和分级光学仪器的研制和临床试验。光散射光谱(LSS)已经被证明可以区分BE患者的正常和病变组织状况，但分析是复杂的，所以数据要在程序结束后进行分析。这项工作开发的仪器将基于白光LSS，但它将使用由NLI开发的特殊探头设计和数据简化算法，从而实现实时结果。探针设计利用了细胞核和其他组织成分的光散射特性，从而能够分离和减去干扰效应，并基于散射过程的光谱、角度和偏振特性来表征细胞核。组织特征是根据仪器对表面粘膜细胞的核大小和数密度的定量测定得出的，这两种特性通常由病理学家使用。具体地说，NLI将(I)生产探头，(Ii)计算实时算法的数据库，(Iii)生产带有光源、光谱仪和嵌入式计算机的仪器(适合与标准临床视频内窥镜接口)，(Iv)使用标准散射材料在实验室验证仪器的操作，(V)使用正常和病变切除的结肠组织验证背景减去特性，以及(Vi)对Barrett‘s食道患者进行临床研究。

DESCRIPTION (provided by applicant): Barrett's esophagus (BE) is an acquired condition of the lower esophagus in which the normal squamous tissue is replaced by a metaplastic columnar mucosa. BE itself is not malignant, but it is the primary risk factor for esophageal adenocarcinoma, and a significant number of patients with BE will have adenocarcinoma at the time of first endoscopy. Currently, examination for dysplasia requires numerous random biopsy samples. This work will complete the development and clinically test an optical instrument for detecting and grading Barrett's dysplasia. Light scattering spectroscopy (LSS) has already been shown to differentiate between normal and diseased tissue conditions in BE patients, but the analysis is complex so the data is analyzed after the procedure is over. The instrument developed by this work will be based on white light LSS, but it will use a special probe design and data reduction algorithm, developed by NLI, enabling real-time results. The probe design makes use of the properties of light scattering by cell nuclei and other tissue components to enable the separation and subtraction of interfering effects, and the characterization of the nuclei, based on using spectral, angular, and polarization characteristics of the scattering processes. The tissue characterization follows from the instrument's quantitative determination of the nuclear size and number density for the surface mucosal cells - two properties commonly used by pathologists. Specifically, NLI will (i) produce the probe, (ii) calculate the data base for the real-time algorithm, (iii) produce the instrument with light source, spectrometer, and embedded computer (suitable for interface with a standard clinical video endoscope), (iv) verify the instrument operation in the laboratory using standard scattering materials, (v) verify the background subtraction properties by using normal and diseased resected colon tissue, and (vi) conduct clinical studies on patients with Barrett's Esophagus.