Nanodevice for Digital Imaging of Palpable Structure at Human-Finger Resolution f

描述(申请人提供)：根据自1963年以来的临床试验，乳房检查(CBE)与乳房X光摄影相结合似乎是在乳腺癌筛查中实现高灵敏度和高特异度的最佳策略，前提是CBE可以通过数字(和标准化)报告进行定量。肿瘤可触及的结构的定量成像可能有助于破译随着时间的推移乳房和前哨淋巴结的异常变化。一种廉价的、非侵入性的筛查工具，能够检测到小到5 mm的肿瘤，可以用于早期检测的序贯方法。这项研究的长期目标是开发一种薄膜纳米设备，即电子皮肤，它将物理接触上的压力分布转换为光，可以直接在数码相机上以与人类手指(~20&lt；m)同等的分辨率成像。通过使用手持工具扫描，类似于CBE，将获得乳房结节结构的定量图像和前哨淋巴结局部硬度的评分。图像将以数字方式存储，其中包含可触摸到的结节的大小和硬度的定量信息。本项目有三个具体目标：1)制作纳米器件，定量研究其性能，以测量高模数可触及肿块的大小(分辨率)，确定可检测到的可触及肿块的最低模数(对比度)，确定产生肿块定量图像所需的平均外加应力(灵敏度)和肿块的硬度(评分)；2)研究和量化可触及肿块表面下的深度对成像(深度分辨率)的影响，研究平均外加应力对深度分辨率的影响，并研究可触及肿块的性质；以及3)对具有结节结构的人工乳房进行类似于特定目标1和2中描述的分析，以便定量地了解曲率对测量图像的影响。 公共卫生相关性开发一种廉价、非侵入性的手持筛查工具，用于乳腺癌的早期检测，可以对肿瘤的触觉及其与周围组织的附着性质进行成像，使家庭医生和其他临床医生能够对无法使用更昂贵的筛查工具的患者进行筛查，并避免乳房X光检查中不必要的辐射暴露。肿块的大小、硬度和触觉的定量图像将提供一套正交测量，这将显著改善临床乳房检查(CBE)的程序，并提高特异性，即低假阳性，以帮助医生做出明智的决定，以便在乳腺癌的早期阶段进行进一步的测试和开始治疗。

DESCRIPTION (provided by applicant): Based on clinical trials since 1963, it appears that breast examination (CBE) in combination with mammography may be the best strategy for high sensitivity and specificity in breast cancer screening provided CBE can be quantitative with digital (and standardized) reporting. Quantitative imaging of the palpable structure of the tumor may help decipher the abnormal changes in the breast and sentinel lymph nodes over time. An inexpensive, noninvasive screening tool with the ability to detect tumors as small as ~5mm could be used in a sequential approach to early detection. The long- term objective of this research is to develop a thin-film nanodevice, i.e., electronic skin, that will convert the pressure distribution on physical contact to light that can be imaged directly on a digital camera at a resolution on par with the human finger (~20 <m). By scanning with the handheld tool, similar to CBE, a quantitative image of the nodular structure of the breast and sentinel lymph node scoring of the local hardness will be obtained. The image will be digitally stored containing quantitative information on both size and hardness of palpable nodules. There are three specific aims for this project: 1) to make a nanodevice to quantitatively study its performance to measure size of the high modulus palpable mass (resolution), determine the lowest modulus of palpable mass that is detectable (contrast), determine the average applied stress needed to produce a quantitative image of the mass (sensitivity), and hardness of the mass (scoring); 2) study and quantify the effect of the depth of the palpable mass beneath the surface on imaging (depth resolution), study the effect of average applied stress on depth resolution, and study the nature of the palpable mass; and 3) perform a similar analysis as described in Specific Aims 1 and 2 on an artificial breast with a nodular structure in order to quantitatively understand the effect of curvature on the measured image. PUBLIC HEALTH RELEVANCE Development of an inexpensive, noninvasive, handheld screening tool for early detection of breast cancer that can image the palpability of a tumor and the nature of its attachment to surrounding tissue will enable family physicians and other clinicians to screen patients who do not have access to the more expensive screening tool and avoid unnecessary exposure to radiation used in mammography. The quantitative image with size, hardness, and palpability of the mass will provide a set of orthogonal measurements that will significantly improve the procedure of clinical breast examination (CBE) and improve specificity, i.e., low false positives, to help physicians make well-informed decisions to perform further testing and initiate therapy at the earliest stages of breast cancer.