Endoscopic OCT Imaging Technology for Surveillance

描述（由申请人提供）： 该研究项目是开发和研究光学相干断层扫描（OCT）成像技术在胃肠道（GI）内窥镜检查中的应用的更大努力的一部分，其主要目的是检测常见人类癌前GI疾病中的发育不良。在许多GI病症中，发育不良是癌症的前兆，并且基本上是基于粘膜的细胞和结构的特定变化的显微镜诊断。一个关键问题是，发育不良的GI粘膜通常不能通过标准GI内窥镜检查检测到。研究者最近的研究已经证明，内窥镜OCT（EOCT）能够以前所未有的分辨率和质量对GI粘膜成像，并且EOCT成为诊断发育异常病变的有力工具的潜力很大。然而，当前EOCT原型的一个显著限制是其有限的视场。它不能对肠腔的整个圆周成像，因此不适合于需要全面覆盖一段管腔的监视应用。该提案的重点是EOCT技术的开发和建立，这将使EOCT的临床试验能够作为在具有癌前GI病症的患者中进行监测的工具。Barrett食管的异型增生是该项目的主要临床目标，而异常结肠隐窝病灶是次要目标。具体目标是：（1）开发新一代EOCT引擎，具有更高的分辨率、更快的图像采集速度和数字信号处理;（2）开发EOCT探头，以提高图像分辨率并实现回撤监测程序;（3）完善EOCT异型增生分类标准，并开发高效准确的计算机辅助诊断（CAD）算法。该技术将逐步发展，并将进行严格的表征和校准，并将通过仔细的体外和体内研究进行验证。该项目的成功完成将使技术的临床评价，预计将显着提高检测胃肠道癌前病变或早期恶性病变的能力，并允许早期治疗干预，这将对患者的护理和生存产生积极影响。

DESCRIPTION (provided by applicant): This research project is part of a larger effort to develop and investigate optical coherence tomography (OCT) imaging technology for applications in gastrointestinal (Gl) endoscopy for the primary purpose of detecting dysplasia in common human pre-malignant Gl conditions. Dysplasia is the precursor of cancer in a number of Gl disorders, and is fundamentally a microscopic diagnosis based on specific changes in the cells and architecture of the mucosa. A key problem is that dysplastic Gl mucosa is usually not detectable by standard Gl endoscopy. Recent studies by the investigators have demonstrated that endoscopic OCT (EOCT) is capable of imaging Gl mucosa with unprecedented resolution and quality, and that the potential is strong for EOCT to become a powerful tool for diagnosis of dysplastic lesions. A significant limitation of the current EOCT prototype, however, is its limited field of view. It is not capable of imaging the entire circumference of the lumen of the gut, and is therefore not suitable for surveillance applications where comprehensive coverage of a segment of lumen is desirable. This proposal is focused on development and establishment of EOCT technology that will enable clinical trials of EOCT as a tool for surveillance in patients with premalignant Gl conditions. Dysplasia in Barrett's Esophagus is the primary clinical target for this project, and aberrant colonic crypt foci are the secondary target. The specific aims are: (1) to develop a new generation EOCT engine featuring improved resolution, improved image acquisition speed, and digital signal processing; (2) to develop EOCT probes to improve image resolution and to enable pull-back surveillance procedures; and (3) to refine the criteria for EOCT classification of dysplasia and develop efficient and accurate computeraided diagnosis (CAD) algorithms. The technology will be developed incrementally and will be rigorously characterized and calibrated and will be validated by careful in vitro and in vivo studies. Successful completion of this project will enable the clinical evaluation of technology that is expected to significantly improve the capacity to detect pre-malignant or early malignant lesions in the Gl tract and allow early therapeutic interventions that will positively impact on patient care and survival.