Oxygen Mapping System for Enhanced Colonoscopic Neoplasm Detection

描述(申请人提供)：95%的结直肠癌是通过一系列众所周知的基因突变而发展起来的，在10-15年的时间框架内开始组织生长，通常被称为息肉。大约三分之一到一半的成年人在一生中会发展成一个或多个息肉，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。内窥镜检查是美国人筛查良性和癌前结肠息肉的主要手段。虽然结肠镜检查可以发现高达95%的癌症病变，但利用目前的标准和增强的技术，息肉大约有25%的时间被遗漏。我们的初步研究已经在癌前息肉和正常结肠组织之间建立了可定量测量的组织氧合差异。这项拟议的研究进一步开发了一种系统，以利用这种生理对比，最终目标是在保持临床效率的同时，通过改进结肠镜检查期间息肉的检测来减少结肠癌。目前还没有临床实用的方法来定量评估结肠镜检查过程中的组织氧合情况，也没有利用这些信息来改进肿瘤性息肉检测的方法。所提出的系统利用穿过传统结肠镜工作通道的成像束来检测和定量测量与正常结肠组织相比存在的息肉中的氧气差异。该系统将使用图形覆盖在传统范围视频图像上突出显示可疑病变。如果发现可疑病变，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。研究工作从开发一种“理想的”试验台系统开始，以克服可行性研究过程中遇到的限制。该试验台将用于研究和优化传感技术，并通过在已证实的基因诱导的结肠肿瘤啮齿动物模型中进行工作台和体内测试来确定关键的设计输入。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。商业候选将在基因定位的猪结肠癌模型中得到验证，并对照其他相关的结肠镜技术和病理真相进行评估，以检验这样一个假设，即在视频结肠镜检查期间，绘制组织氧合图可以更容易地发现肿瘤/癌前病变。在这项工作中开发的系统和获得的数据将成为申请豁免调查设备进行第一人试验的基础。

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.