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

基于办公室的早期喉癌实时高速3D-OCT诊断系统

• 批准号: 8525019
• 负责人: Tirunelveli Ramalingam
• 金额: $ 92.85万
• 依托单位: OCT MEDICAL IMAGING, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8525019
• 关键词: Address; Animals; Appearance; Area; Asia; Automation; Benign; Beryllium; Biomedical Engineering; Biopsy; California; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Contracts; Coughing; Detection; Development; Diagnosis; Diagnostic; Disease; Disease Progression; Dysphonia; Early Diagnosis; Endoscopes; Endoscopic Surgical Procedures; Endoscopy; Engineering; Ensure; Environment; Epithelial; Family; Fiber Optics; Funding; Future; General Anesthesia; Goals; Hand; Head and Neck Cancer; Head and neck structure; Hoarseness; Housing; Human; Image; Image Analysis; Imagery; Imaging technology; Laboratories; Larynx; Lasers; Lead; Legal patent; Length; Lesion; Letters; Licensing; Light; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of larynx; Manuals; Marketing; Medical Device; Medical Imaging; Microanatomy; Microsurgery; Modeling; Modification; Monitor; Morbidity - disease rate; Morphologic artifacts; Motion; Nose; Operative Surgical Procedures; Optical Coherence Tomography; Optics; Otolaryngologist; Outcome; Pain; Patients; Penetration; Pennsylvania; Pharyngeal structure; Phase; Physical Examination; Pilot Projects; Positioning Attribute; Premalignant; Probability; Problem Solving; Procedures; Radiology Specialty; Reporting; Research; Research Personnel; Resolution; Sales; Scanning; Screening for cancer; Sedation procedure; Sensitivity and Specificity; Side; Solid Neoplasm; Source; Speed; Structure; Surface; Symptoms; System; Systems Development; Technology; Testing; Three-Dimensional Imaging; Time; Tissues; Tremor; United States National Institutes of Health; Universities; Visual; Work; abstracting; base; cancer diagnosis; cancer site; cancer therapy; clinical application; clinically relevant; commercialization; cost; cost effective; design; flexibility; high risk; human study; imaging modality; improved; in vivo; larynx Carcinoma; millimeter; mortality; optical imaging; point of care; programs; public health relevance; response; screening; software development; two-dimensional; vocal cord

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

描述（由申请人提供）：喉癌是最常见的原发性头部和颈部恶性肿瘤。通常通过鼻子或咽部插入柔性纤维或刚性内窥镜进行常规的身体检查，但仅单独内窥镜检查不能用来区分良性，身体恶化和早期恶性病变，这些病变的特征是，这些症状具有相同的症状，例如喉咙疼痛，咳嗽，court脚，嘶哑的身体外观，以及几乎识别的物理性。常规检查和内窥镜检查都无法能够可视化疾病渗透到更深层的深度 组织的内容，并提供有关声带上皮结构的信息。因此，喉癌诊断必须依靠活检，这需要全身麻醉和手术内窥镜检查。多次和重复的活检是常见的，以增加诊断产量，并且随着发病率的增加手术。 不管对患者及其家人造成的损失如何，手术的重大费用以及大量的患者离开工作时间。因此，非常需要开发快速，移动和无创的技术来帮助早期发现和监测喉恶性病变，并有助于选择患者进行手术活检。 使用OCT在管理早期喉上皮癌中的使用将类似于使用宏观成像方式（即MR，CT）来管理体内大型实体瘤。 OCT Medical Imaging Inc.（OCTMI）使用几项许可的专利提议使用基于光的光纤成像技术（OCT）（OCT）来解决早期喉癌的治疗和诊断，该技术可在近组织病理学分辨率（Fujimoto et.Al 2000）上产生横截面图像。 1997年报道了动物和人类中第一个体内内窥镜OCT图像（Tearney等，1997））。 许多临床应用需要大面积或3D成像，即 很难通过OCT时域（TD）实现。因此，OctMI建议使用高级傅立叶域（FD）OCT技术，该技术可在高速和灵敏度下提供3D成像（Leitgeb等，2003）。其次，必须从基于办公室的成像或基于办公室成像的范式转移，以使OCT成为头颈癌筛查，早期检测和监测疾病进展的有用技术。 Octmi纳入了这项技术，建议开发一个高级紧凑的，具有成本效益的办公室的实时3D功能傅里叶域功能性OCT系统，该系统不仅将在接近组织病理学分辨率下获取图像，而且还将提供有关临床上重要的结构信息 可疑病变，潜在的活检部位和喉部的癌症边缘，而无需全身麻醉或镇静。 OCTMI非常有能力开发这项技术，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，并且首先对我们的喉癌进行了大规模的临床试验，据我们所知