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

描述（由申请人提供）：喉癌是最常见的原发性头颈部恶性肿瘤。柔性光纤或刚性内窥镜通常通过鼻子或咽部插入进行常规体检，但内窥镜不能单独用于区分良性，癌前病变和早期恶性病变，其特征在于相同的症状，如咽喉疼痛，咳嗽或声音嘶哑，以及几乎相同的物理外观。传统的检查和内窥镜检查都缺乏可视化疾病渗透到更深层的能力 的组织，并提供声带上皮结构的信息。因此，喉癌的诊断必须依靠活检，这需要全身麻醉和手术内窥镜。为了增加诊断率，多次和重复活检是常见的，并且随着这种增加，手术的发病率也增加。 无论对患者及其家属造成多大的损失，手术都有很大的成本，而且患者离开工作的时间也很长。因此，迫切需要开发一种快速、移动的和非侵入性的技术，以帮助早期发现和监测喉恶性病变，帮助选择患者进行手术活检。 OCT在处理早期喉上皮癌中的使用将类似于宏观成像模式的使用（即，MR、CT）在治疗体内大型实体瘤中的应用。 利用多项授权专利，OCT Medical Imaging Inc. （OCTMI）提出使用被称为光学相干断层扫描（OCT）的基于光的光纤成像技术来解决早期喉癌的治疗和诊断，该技术以接近组织病理学分辨率产生横截面图像（Fujimoto et.al 2000）。1997年报道了动物和人类的第一个体内内窥镜OCT图像（Tearney等人，1997年））。 许多临床应用需要大面积或3-D成像，这是非常困难的。 因此，OCTMI提出使用先进的傅立叶域（FD）OCT技术，该技术提供高速和高灵敏度的3D成像（Leitgeb等人，2003年）。其次，从基于OR的成像到基于办公室的成像的范式转变是必要的，以使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。为了验证这项技术，OCTMI提出开发一种先进的紧凑型、具有成本效益的基于办公室的实时3D功能傅立叶域功能OCT系统，该系统不仅可以以接近组织病理学的分辨率采集图像，而且还可以提供临床上重要的结构信息， 可疑病变、潜在活检部位和喉部癌缘，无需全身麻醉或镇静。OCTMI在开发这项技术方面处于有利地位，因为其创始人和合作者已经开发了几种基于办公室的实时3D-OCT系统，并且据我们所知，首先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