Endoscopic OCT Imaging Technology for Surveillance

描述(由申请人提供)： 这项研究是开发和研究光学相干断层扫描(OCT)成像技术在胃肠道(Gl)内窥镜检查中应用的更大努力的一部分，主要目的是检测常见的人类癌前病变Gl情况下的异型增生。异型增生是许多G1疾病的癌症先兆，从根本上说是一种基于粘膜细胞和结构的特定变化的显微镜诊断。一个关键的问题是，标准的G1内窥镜检查通常不能发现发育不良的G1粘膜。研究人员最近的研究表明，内窥镜OCT(EOCT)能够以前所未有的分辨率和质量成像Gl粘膜，EOCT有很强的潜力成为诊断异常增生性病变的有力工具。然而，目前的EOCT原型的一个重大限制是它的视野有限。它不能成像肠道管腔的整个周长，因此不适合需要全面覆盖一段管腔的监视应用。这项建议的重点是开发和建立EOCT技术，使EOCT能够作为监测癌前G1疾病患者的一种工具进行临床试验。Barrett‘s食道异型增生是该项目的主要临床靶点，而迷走性结肠隐窝病灶是次要靶点。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退监视程序；(3)完善EOCT对异型增生的分类标准，开发高效和准确的计算机辅助诊断(CAD)算法。这项技术将逐步开发，并将经过严格的表征和校准，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这项技术的临床评估成为可能，预计这项技术将显著提高发现胃肠道癌前病变或早期恶性病变的能力，并允许进行早期治疗干预，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.