Oxygen Mapping System for Enhanced Colonoscopic Neoplasm Detection

描述（由申请人提供）：95%的结直肠癌是由一系列众所周知的基因突变在10-15年的时间框架内发展而来的，从组织生长开始，通常被称为息肉。大约三分之一到一半的成年人在他们的一生中会患上一个或多个息肉，其中大约10%会发展成结肠癌。因此，绝大多数结直肠癌是可以通过在恶性转化前的早期发现和切除息肉来避免的。内镜检查是美国人群筛查良性和恶性前结肠息肉的主要手段。虽然结肠镜检查可以发现高达95%的癌性病变，但使用目前的标准和“增强”技术，息肉的漏诊率约为25%。我们的初步研究已经在恶性息肉前期和正常结肠组织之间建立了定量可测量的组织氧合差异。本研究进一步开发了一种利用这种生理对比的系统，其最终目标是在保持临床效率的同时，通过提高结肠镜筛查过程中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，也没有方法利用这些信息来提高肿瘤息肉的检测。该系统利用一个成像束，通过传统结肠镜的工作通道来检测和定量测量与正常结肠组织相比存在于息肉中的氧差异。该系统将使用图形叠加在传统的范围视频图像上突出可疑病变。如果识别出可疑病变，系统将允许将成像束交换到另一台仪器，同时保留/跟踪视频监视器上突出显示的病变。研究工作从开发一个“理想的”试验台系统开始，以克服可行性研究中遇到的限制。该试验台将用于研究和优化传感技术，并在经过验证的遗传诱导结肠肿瘤啮齿动物模型中使用台式和体内测试来确定关键的设计输入。结果将反馈到商业候选产品的开发中，满足既定的设计要求，同时保持商业可行性。商业候选药物将在基因定位的结肠癌猪模型中进行验证，并与其他相关结肠镜检查技术和病理真相进行评估，以验证在视频结肠镜检查过程中定位组织氧合可以更容易地检测肿瘤/肿瘤前病变的假设。在这项工作中开发的系统和获得的数据将构成申请研究器械豁免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.