Office based real-time high speed 3D-OCT system for diagnosis of early laryngeal

描述(申请人提供)：喉癌是最常见的头颈部原发恶性肿瘤。柔性光纤或硬质内窥镜通常通过鼻子或咽部插入进行常规体检，但仅使用内窥镜不能区分良性、癌前和早期恶性病变，这些病变的特征是相同的症状，如喉咙痛、咳嗽或声音嘶哑，以及几乎相同的身体外观。常规检查和内窥镜检查都缺乏显示疾病深入深层的能力。 并提供有关声带上皮结构的信息。因此，喉癌的诊断必须依靠活检，这需要全身麻醉和外科内窥镜检查。为了提高诊断率，多次和重复的活组织检查是很常见的，而且手术的发病率也在增加。不管给患者及其家人造成了多大的损失，与手术相关的主要成本，以及患者离开工作岗位的大量时间。因此，迫切需要开发一种快速、移动和非侵入性的技术来辅助喉部恶性病变的早期发现和监测，帮助选择接受手术活检的患者。OCT在治疗早期喉上皮癌中的使用将类似于在体内使用宏观成像方式(即MR、CT)来处理大型实体肿瘤。OCT医学成像公司(OCTMI)利用几项获得许可的专利，建议使用基于光的光纤成像技术来治疗和诊断早期喉癌，该技术称为光学相干断层扫描(OCT)，它可以产生接近组织病理学分辨率的横断面图像(Fujimoto et.al 2000)。1997年首次报道了动物和人类的活体内窥镜OCT图像(Tearney等人，1997)。许多临床应用需要大面积或3D成像，这是 使用时间域(TD)OCT很难实现。因此，OCTMI建议使用先进的傅立叶域(FD)OCT技术，该技术提供高速和灵敏的3D成像(Leitgeb等人，2003)。其次，为了使OCT成为头颈部癌症筛查、早期检测和疾病进展监测的有用技术，必须将OCT的范式从基于OR的成像转变为基于办公室的成像。结合这项技术，OCTMI建议开发一种先进的紧凑、经济高效的基于办公室的实时3D功能傅立叶域功能OCT系统，该系统不仅将获得接近组织病理学分辨率的图像，而且将提供临床上重要的结构信息 可疑的病变、潜在的活检部位和喉癌边缘在办公室内，而不需要全身麻醉或镇静。OCTMI处于开发这项技术的有利地位，因为它的创始人和合作者已经开发了几个基于办公室的实时3D-OCT系统，并据我们所知首次对喉癌进行了大规模临床试验

DESCRIPTION (provided by applicant): Laryngeal carcinoma is the most common primary head and neck malignancy. Flexible fiber-optic or rigid endoscopes are normally inserted through the nose or into the pharynx for conventional physical examinations, but endoscopy alone cannot be used to differentiate between benign, pre-malignant and early malignant lesions, which are characterized by identical symptoms such as throat pain, coughing, or hoarseness, and nearly identical physical appearance. Both conventional examination and endoscopy lack the ability to visualize the depth of penetration of disease into the deeper layers of the tissue, and provide information on vocal fold epithelial structure. Therefore, laryngeal cancer diagnosis has to rely on biopsies, which requires general anesthesia and surgical endoscopy. Multiple and repeated biopsies are common in order to increase diagnostic yield, and with this increasing morbidity form surgery. Regardless of the toll exacted on patients and their families, there are major costs associated with surgery, and significant patient time away from work. Hence, there is a huge need to develop a fast, mobile and noninvasive technology to aid in the early detection and monitoring of laryngeal malignant lesions, assist in selecting patients to undergo surgical biopsy. The use of OCT in managing early laryngeal epithelial cancer will be analogous to the use of macroscopic imaging modalities (i.e., MR, CT) in managing large solid tumors in the body. Using several licensed patents, OCT Medical Imaging Inc. (OCTMI) proposes to address the treatment and diagnosis of early laryngeal cancer using light based fiber optic imaging technology known as optical Coherence tomography (OCT), which produces a cross- sectional images at near histopathological resolution(Fujimoto et.al 2000). The first in vivo endoscopic OCT images in animals and humans were reported in 1997 (Tearney et.al., 1997)). Many clinical applications require a large area or 3-D imaging, which is difficult to achieve with the Time Domain (TD) OCT. Hence, OCTMI proposes to use advanced Fourier domain (FD) OCT technology which provides 3D imaging at high speed and sensitivity ( Leitgeb et.al., 2003). Second, the paradigm shift from OR based to office-based imaging is necessary to make OCT a useful technology for head and neck cancer screening, early detection, and monitoring of disease progression. Incorporating this technology, OCTMI proposes to develop an advanced compact, cost-effective office based real-time 3D-functional Fourier domain functional OCT system that will not only acquire images at near histopathological resolution, but also will provide clinically important structural information on suspect lesions, potential biopsy sites, and cancer margins of larynx in the office without the need for general anesthesia or sedation. OCTMI is well positioned to develop this technology since its founders and collaborators have developed several office-based real-time 3D-OCT systems and were first to conduct large scale clinical trials on laryngeal cancer to the best of our knowledge