Novel Optical System for Early Cervical Cancer Detection

描述(由申请人提供)： 2002年，美国将诊断出大约13,000例浸润性宫颈癌，大约4,100名妇女将死于这种疾病。早期浸润性宫颈癌的5年相对生存率为91%。宫颈癌的总体(所有阶段加在一起)5年生存率约为70%。宫颈癌前病变的5年生存率接近100%。因此，早期发现宫颈癌前病变可以对宫颈癌死亡率产生巨大影响，将五年生存率从70%提高到约100%。 常规巴氏涂片(Pap)是目前宫颈癌和癌前筛查的标准，然而，许多研究表明，这种方法可能会漏掉多达20%-30%的宫颈癌。因此，宫颈组织的自体荧光检查被认为是提高对宫颈早期肿瘤性改变的敏感性的一种手段。虽然这项技术的敏感性可高达85-90%，但其特异性较低，导致大量假阳性。 光学相干层析成像(OCT)是一种新型的非侵入性成像技术，它能够以接近常规光学显微镜的分辨率成像软组织的形态细节。然而，OCT的时间和成像范围小，使其本身不适用于常规筛查。 此前，在上皮性癌的动物模型中，我们已经证明，使用组织自发荧光成像来指导OCT成像的选择性应用导致了一种比单独使用荧光成像具有更高的灵敏度和特异性的技术。我们推测，荧光图像引导的OCT(FIGOCT)可能成为一种有用的临床工具，用于宫颈组织的评估和筛查。在这个方案中，我们设计、制造和测试了一种新的光学探头，适用于探索FIG-OCT在人类宫颈中的可行性。这样的探头将有助于检测身体其他容易接触到的部位的上皮性癌症，包括尿路、膀胱、胃肠道、结肠和口腔。

DESCRIPTION (provided by applicant): Approximately 13,000 cases of invasive cervical cancer will be diagnosed in the United States, in 2002, and approximately 4,100 women will die from the disease. The 5-year relative survival rate for the earliest stage of invasive cervical cancer is 91%. The overall (all stages combined) 5-year survival rate for cervical cancer is about 70%. For cervical precancer the 5-year survival rate is nearly 100%. Thus, early detection of cervical precancerous lesions can have a dramatic impact on cervical cancer mortality rates, increasing five-year survival rates from 70% to about 100%. Routine Papanicolaou (Pap) smear is the current standard for cervical cancer and pre-cancer screening, however, a number of studies have indicated that this method may miss as many as 20-30% of cervical cancers. For this reason, tissue autofluorescence examination of cervical tissue has been examined as a means for increasing sensitivity to early neoplastic changes in the cervix. While sensitivity of this technique can be as high as 85-90%, its specificity is low resulting in significant numbers of false positives. Optical coherence tomography (OCT) is a new non-invasive imaging technique which can image morphological details of soft tissues with resolution close to that of conventional light microscopy. However, the time and small imaging field associated with OCT make it impractical for routine screening by itself. Previously, in an animal model of epithelial cancer, we have demonstrated that the use of tissue autofluorescence imaging used to guide selective application of OCT imaging results in a technique with superior sensitivity and specificity over fluorescence imaging alone. We hypothesize that fluorescence image guided OCT (FIGOCT) may become a useful clinical tool for the evaluation and screening of cervical tissues. In this proposal we design, build, and test a new optical probe suitable for exploring the feasibility of FIG-OCT in the human cervix. Such a probe would be useful in detecting epithelial cancers in other easily accessible sites in the body including the urinary tract, bladder, gastro-intestinal tract, colon, and oral cavity.