Validation and commercialization of a/LCI for detection of esophageal neoplasia

用于检测食管肿瘤的 a/LCI 的验证和商业化

• 批准号: 8333979
• 负责人: Steven Charles Gebhart
• 金额: $ 98.04万
• 依托单位: ONCOSCOPE, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-29 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8333979
• 关键词: Ablation; Acids; Barrett Esophagus; Biopsy; Cessation of life; Characteristics; Chronic; Clinical; Clinical Trials; Computer software; Contracts; Coupling; Data; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic Neoplasm Staging; Discrimination; Disease; Disease Progression; Dysplasia; Early Diagnosis; Endoscopic Biopsy; Endoscopy; Enrollment; Epithelial; Epithelium; Esophageal; Esophageal Adenocarcinoma; Esophageal Intraepithelial Neoplasia; Esophagus; Evaluation; Excision; Excision biopsy; Feedback; Focal Dysplasia; Frequencies; Future; Gastroesophageal reflux disease; Goals; Health; Health Care Costs; Histopathology; Image; In Situ; Incidence; Instruction; Interferometry; Lead; Lesion by Stage; Light; Malignant neoplasm of esophagus; Manufacturer Name; Measurement; Methods; Modeling; Nature; Neoplasms; Nuclear; Optics; Outcome; Output; Pathology; Patients; Phase; Prevalence; Probability; Procedures; Process; Production; Quality of life; Rattus; Reflux; Relative (related person); Research; Research Design; Risk; Risk Factors; Screening for cancer; Small Business Innovation Research Grant; Speed; Staging; Sterilization; Stratum Basale; Survival Rate; System; Techniques; Technology; Testing; Time; Tissues; United States National Institutes of Health; Validation; Work; arm; base; clinical practice; clinical research site; commercialization; cost; design; improved; in vivo; instrument; manufacturing process; meetings; millisecond; novel; pilot trial; product development; programs; prospective; prototype; research clinical testing; standard of care; tool; tumor progression; verification and validation

Project Summary The objective of this research is to commercialize a device (the Oncoscope Panocyte" system) used to guide biopsy selection in patients with Barrett's esophagus (BE) during standard endoscopy surveillance for early- stage esophageal cancer. Barrett's esophagus most often develops in patients with chronic acid reflux and is the strongest risk factor for development of esophageal adenocarcinoma. The current standard of care for surveillance, random biopsy guided by white-light endoscopy, is severely limited, since early-stage lesions are not visible during imaging and only a small amount of at-risk tissue can be screened during a single procedure. The Panocyte" system utilizes technology based on angle-resolved low coherence interferometry (a/LCI). It provides a highly sensitive tool for cancer screening through its ability to make quantitative measurements of cellular characteristics, such as nuclear size, that are known to be highly correlated to cancer progression. The non-invasive and real-time nature of the Panocyte" system allows clinicians to examine a greater portion of at-risk tissue, and its ability to selectively probe the basal layer of tissue, where disease first manifests, allows them to detect esophageal cancer in its pre-cancer stages when it is effectively treatable. With these capabilities, using Panocyte" to guide biopsy selection during esophageal endoscopy procedures could ultimately deliver earlier detection via more thorough examination, a reduction in health-care costs by minimizing biopsy of non-dysplastic tissue, and overall improvement in patient outcomes and quality of life. In Phase I of the NIH SBIR program, Oncoscope successfully developed a commercial prototype a/LCI device capable of discriminating between non-dysplastic and dysplastic tissues in a rat Barrett's esophagus model. In Phase II, we expanded on the Phase I work by improving the Panocyte" system design for enhanced commercial and clinical viability, while also demonstrating its clinical operating characteristics in vivo as part of a 175-patient pilot trial. With the following specific aims, our research plan for Phase IIB will build further toward full commercialization by conducting product verification and validation of the esophageal a/LCI clinical system, culminating in the submission of our regulatory application to the FDA for a/LCI-guided excisional biopsy in the esophagus: (1) Finalize product development and perform initial manufacturing and assembly in order to complete design verification of the esophageal a/LCI clinical system, (2) Conduct pivotal clinical trial and user interface study for design validation of using a/LCI to guide excisional biopsy in the esophagus, and (3) Complete manufacturing process validation and design transfer of the esophageal a/LCI clinical system.

项目摘要 本研究的目的是商业化的设备（Oncoscope Panocyte系统），用于引导 在标准内镜监测期间Barrett食管（BE）患者的活检选择， 食管癌分期巴雷特食管最常见于慢性酸反流患者， 是食管腺癌发生的最强危险因素。的当前标准治疗 白光内镜引导下的随机活检是非常有限的，因为早期病变 在成像过程中不可见，并且在单个过程中只能筛选少量的风险组织。 Panocyte”系统利用基于角度分辨低相干干涉测量（a/LCI）的技术。它 提供了一种高灵敏度的癌症筛查工具，通过其定量测量的能力， 已知与癌症进展高度相关的细胞特征，如核大小。的 Panocyte”系统的非侵入性和实时性使临床医生能够检查更大部分的 风险组织，以及其选择性探测疾病首先显现的组织基底层的能力， 他们发现食管癌在其癌前阶段时，它是有效的治疗。与这些 功能，使用Panocyte”在食管内窥镜检查过程中指导活检选择， 通过更彻底的检查，最终实现更早的检测， 最大限度地减少非异型增生组织的活检，以及患者结局和生活质量的总体改善。 在NIH SBIR计划的第一阶段，Oncoscope成功开发了一种商业原型a/LCI设备 能够在大鼠巴雷特食管模型中区分非发育异常组织和发育异常组织。在 在第二阶段，我们通过改进Panocyte系统设计， 商业和临床可行性，同时也证明了其作为 一个175名患者的试点试验我们的第二B期研究计划会进一步发展以下的具体目的， 通过对食管a/LCI临床进行产品验证和确认， 系统，最终我们向FDA提交了监管申请，要求进行LCI引导的切除术 食管活检：（1）完成产品开发，并在 完成食管a/LCI临床系统的设计验证，（2）进行关键临床试验 和使用/LCI引导食管切除活检的设计确认的用户界面研究，以及 (3)完成食管a/LCI临床系统的制造过程确认和设计转移。