3D Tracking for OCT Image Fusion in Gynecological Diagnosis

描述(由申请人提供)：该SBIR二期项目的目标是继续开发一个基于光学相干层析成像采集与实时3D空间定位相结合的令人兴奋的平台。在第一阶段，在妇科诊断成像的背景下，我们演示了阴道镜/阴道成像和宫颈OCT图像之间的原型图像融合的硬件和软件。我们还展示了一种很有前途的方法，可以简化三维OCT数据集的获取，具有广泛的应用前景。在这个项目中，我们在这些有希望的结果的基础上定义和开发两种新产品。第一个将是临床跟踪和软件系统，它将增强OCT成像系统，以提供OCT和镜图像之间的融合，以及用于分析、审查和报告图像发现的工具。第二个将由软件和成像/跟踪探头组成，该探头可以(由最终用户)容易地连接到市场上可获得的OCT系统，一旦安装，将允许从简单的手动扫描的2D数据重建3D OCT数据集。这些设备将在幻影和动物模型以及临床上进行验证。在这一应用继续聚焦于妇科诊断的同时，我们也将为这项技术未来在其他领域的发展奠定重要的实验基础。 公共卫生相关性：2010年，美国预计将诊断出大约12,200例浸润性宫颈癌，据估计，非浸润性宫颈癌(原位癌)的发病率约为[：//www.cancer.gov/cancertopics/types/cervical].的四倍2010年，美国预计将有大约4210名妇女死于宫颈癌。尽管与宫颈癌相关的死亡率在过去50年中大幅下降，但宫颈癌前病变的发病率却在上升，而且有人认为，如果不改进目前的筛查和诊断技术，与宫颈癌相关的死亡率可能会上升，特别是如果人类乳头状瘤病毒(HPV)血清阳性率继续上升的话。宫颈癌前期病变的早期发现可以对宫颈癌死亡率产生巨大影响，将五年存活率从70%提高到约100%。本项目致力于开发一种新的成像系统，以提高宫颈组织的诊断和定性。这项开发的技术在其他诊断领域也有广泛的应用，包括心脏病学、腹腔镜和胃肠病学。

DESCRIPTION (provided by applicant): The goal of this Phase II SBIR project is to continue development of an exciting platform based on integration of optical coherence tomography acquisition with real-time 3D spatial localization. In Phase I, in the context of gynecological diagnostic imaging, we demonstrated hardware and software for prototype image fusion between colposcopic/intravaginal imaging and OCT images of the cervix. We also demonstrated a promising methodology for simplified acquisition of 3D OCT data sets which may have broad application. In this project, we build upon these promising results to define and develop two new products. The first will be a clinical tracking and software system which augments an OCT imaging system to provide fusion between OCT and colposcopic images as well as tools for analyzing, reviewing, and reporting image findings. The second will consist of software and an imaging/tracking probe which can be readily coupled (by an end user) to commercially available OCT systems and which, when installed, will allow reconstruction of 3D OCT datasets from simple manually scanned 2D data. Devices will be validated in phantoms and animal models as well as clinically. While this application continues to be focused on gynecological diagnosis, we will also lay important experimental groundwork for future development of this technology in other fields. PUBLIC HEALTH RELEVANCE: In 2010, approximately 12,200 cases of invasive cervical cancer are expected to be diagnosed in the United States, and it is estimated that incidence of noninvasive cervical cancer (carcinoma in situ) is about four times as high [://www.cancer.gov/cancertopics/types/cervical]. Approximately 4,210 women are expected to die from cervical cancer in the United States during 2010. Though mortality rates associated with cervical cancer have decreased dramatically over the last 50 years, the incidence of cervical precancers has increased, and it has been suggested that without improvement in current screening and diagnostic techniques, mortality rates associated with cervical carcinoma could increase, especially if human papilloma virus (HPV) seroprevalence continues to rise. 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%. This project focuses on development of a novel imaging system for improving diagnosis and characterization of cervical tissue. The developed technology also has wide application in other diagnostic fields including cardiology, laparoscopy, and gastroenterology.