Oxygen Mapping System for Enhanced Colonoscopic Neoplasm Detection

描述（由申请人提供）：95%的结直肠癌在10-15年的时间范围内由一系列众所周知的基因突变发展而来，最初是组织生长，通常称为息肉。大约三分之一到一半的成年人在一生中会发展出一个或多个息肉，其中大约10%会发展为结肠癌。因此，绝大多数结直肠癌可以通过在恶变之前的早期阶段识别和切除息肉来避免。内镜检查是美国人群筛查良性和癌前病变结肠息肉的主要手段。虽然结肠镜检查可以检测到高达95%的癌性病变，但使用当前的标准和“增强”技术，大约25%的时间会错过息肉。我们的初步研究已经建立了一个定量测量的差异，组织氧癌前病变息肉和正常结肠组织。拟议的研究进一步开发了一种系统，以利用这种生理对比，最终目标是通过在筛查结肠镜检查期间改善息肉检测来减少结肠癌，同时保持临床效率。目前还没有在结肠镜检查期间定量评估组织氧合的临床实用方法或使用这种信息来改善肿瘤性息肉检测的方法。所提出的系统利用延伸通过传统结肠镜的工作通道的成像束来检测和定量测量当与正常结肠组织相比时存在于息肉中的氧差异。该系统将使用图形叠加在传统内窥镜视频图像上突出显示可疑病变。如果识别出可疑病变，系统将允许将成像束更换为另一台仪器，同时保留/跟踪视频监视器上突出显示的病变。研究工作从开发“理想”试验台系统开始，以克服可行性研究期间遇到的限制。该试验台将用于研究和优化传感技术，并在经证实的遗传诱导结肠肿瘤啮齿动物模型中使用实验室和体内试验确定关键设计输入。这些结果将用于开发符合既定设计要求的商业候选产品，同时保持商业可行性。将在基因映射的结肠癌猪模型中验证商业候选物，并根据其他相关结肠镜检查技术和病理学事实进行评价，以检验视频结肠镜检查期间映射组织氧合可以更容易检测肿瘤/肿瘤前病变的假设。在此过程中开发的系统和获得的数据将构成申请试验用器械豁免以进行首次人体试验的基础。

DESCRIPTION (provided by applicant): Ninety five percent of colorectal cancer develops by a well understood series of genetic mutations over a 10-15 year time frame beginning as a tissue growth, commonly termed a polyp. Approximately one third to one half of adults will develop one or more polyps over their lifetime, approximately ten percent of which will progress to colon cancer. Therefore the overwhelming majority of colorectal cancers can be avoided by identification and removal of polyps at an early stage before malignant conversion. Endoscopy is the predominant means by which the US population is screened for benign and pre- malignant colonic polyps. While colonoscopy can detect up to 95% of cancerous lesions, polyps are missed approximately 25% of the time utilizing current standard and "enhanced" techniques. Our preliminary studies have established a quantitatively measurable difference in tissue oxygenation between pre-malignant polyps and normal colonic tissue. The proposed research further develops a system to exploit this physiologic contrast with an ultimate goal of reducing colon cancer through improved detection of polyps during screening colonoscopy while maintaining clinical efficiency. There is currently no clinically practical method of quantitativel assessing tissue oxygenation during colonoscopy or method of using such information to improve neoplastic polyp detection. The proposed system utilizes an imaging bundle that extends through the working channel of a traditional colonoscope to detect and quantitatively measure oxygen differences that exist in polyps when compared to normal colonic tissue. The system will highlight suspicious lesions on traditional scope video images using graphic overlay. If a suspicious lesion is identified the system will allow for exchange of the imaging bundle for another instrument, while retaining / tracking the lesion highlighted on the video monitor. The research effort commences with the development of an "ideal" testbed system to overcome limitations experienced during feasibility studies. The testbed will be utilized to study and optimize sensing technique and determine critical design inputs using both bench top and in-vivo testing in a proven rodent model of genetically induced colonic neoplasms. The results will feed forward into development of a commercial candidate meeting established design requirements while maintaining commercial viability. The commercial candidate will be validated in a gene-mapped porcine model of colon cancer, and evaluated against other relevant colonoscopy technologies and pathological truth to test the hypothesis that mapping tissue oxygenation, during video colonoscopy, can more readily detect neoplastic / pre-neoplastic lesions. The system developed and data obtained in this effort will form the basis to apply for investigational device exemption to conduct first-in-man trials.