Diagnosis of Ovarian Cancer by Confocal Microendoscopy

描述(由申请人提供)： 本研究的目的是开发一种早期发现卵巢癌的筛查工具，能够使用微创手术途径诊断卵巢微小癌或异常区域。卵巢癌是所有妇科疾病中死亡率最高的，因为它通常在晚期被诊断出来，导致总体预后较差。荧光共聚焦显微内窥镜是一种在细胞水平上显示组织的新型仪器，在光学活检方面显示出巨大的前景。初步工作表明，这种仪器在成像和识别卵巢病理方面具有巨大的潜力。共焦显微镜能够提高医生的诊断能力，并最终提供一种自动图像分析工具，用于实时活体病理诊断。具体工作目标如下：1)研制可在临床上常规可靠使用的第三代共焦显微内窥镜仪器。该系统将紧凑、可移动，并包含高灵敏度的灰度和多光谱成像能力。2)建立可靠的外源性荧光造影剂局部给药机制。理想情况下，这将是一种非(或最小)接触技术，可以很好地控制组织暴露于外源性物质。3)将自动实时模式识别能力融入系统。这种能力将有助于外科医生在卵巢表面的连续成像过程中识别病理。4)评价卵巢表面局部注射特异性荧光化合物S作为造影剂的安全性和有效性。这项工作将在啮齿动物模型中完成。5)论证该仪器用于人体卵巢活体成像的可行性。这将证明基本制度概念是可行的，并指出需要解决的实际问题。6)评价临床卵巢病理检测仪器的有效性。这将是一项更广泛的研究，以评估这项技术在包括正常卵巢、良性肿瘤和癌症在内的一系列组织学诊断中的敏感性和特异性。临床评估将在一组计划接受卵巢切除术的女性中进行。

DESCRIPTION (provided by applicant): The objective of this research is to develop a screening tool for the early detection of ovarian cancer with the capability of diagnosing microscopic cancers or areas of abnormality in the ovary using minimally invasive surgical access. Ovarian cancer has the highest mortality of any of the gynecologic conditions because it is usually diagnosed in late stages leading to poor overall prognosis for survival. The fluorescence confocal microendoscope is a new type of instrument for visualizing tissue at the cellular level that has shown great promise for performing optical biopsy. Preliminary work suggests significant potential for this instrument in imaging and identifying pathology in the ovary. Confocal microscopy has the capability to enhance a physicians' diagnostic ability and ultimately provide an automated image analytic tool for real-time in vivo diagnosis of pathology. The specific aims of the work are as follows: 1) To build a third-generation confocal microendoscope instrument that can be used routinely and reliably in the clinic. The system will be compact, mobile, and incorporate high sensitivity grayscale and multi-spectral imaging capabilities. 2) To develop a reliable mechanism for localized delivery of exogenous fluorescence contrast agent. Ideally this will be a non- (or minimum) contact technique that will allow well-controlled exposure of tissue to the exogenous agents. 3) To incorporate automated real-time pattern recognition capability into the system. This capability will assist the operating physician in identifying pathology during continuous imaging of the surface of the ovary. 4) To evaluate the safety and efficacy of specific fluorescent compound(s) for use as contrast agents in the peritoneal cavity that will be delivered topically to the surface of the ovary. This work will be done in a rodent model. 5) To demonstrate the feasibility of using the instrument for in vivo imaging of human ovary. This will prove that the basic system concept works and to point out practical issues that need to be addressed. 6) To assess the efficacy of the clinical instrument for detection of pathology of the ovary. This will be a more extensive study to evaluate the sensitivity and specificity of this technique across a range of histologic diagnoses including normal ovary, benign neoplasms, and cancers. The clinical evaluations will be done in a cohort of women who are scheduled to undergo oophrectomy procedures.