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

描述（由申请人提供）：基于自1963年以来的临床试验，乳腺检查（CBE）结合乳房X线摄影似乎是乳腺癌筛查中高灵敏度和特异性的最佳策略，前提是CBE可以通过数字（和标准化）报告进行定量。可触及的肿瘤结构的定量成像可能有助于解释乳腺和前哨淋巴结随时间的异常变化。一种廉价的、非侵入性的筛查工具，能够检测到小至~ 5 mm的肿瘤，可以用于早期检测的顺序方法。这项研究的长期目标是开发一种薄膜纳米器件，即，电子皮肤，将物理接触的压力分布转换为可以直接在数码相机上成像的光，其分辨率与人类手指相当（~20 μ m）。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局部硬度的前哨淋巴结评分。图像将以数字方式存储，其中包含可触及结节的大小和硬度的定量信息。本计画有三个具体目标：1）制作一奈米装置，以定量研究其量测高模数可触知肿块大小的效能（分辨率），确定可检测到的可触及肿块的最低模量（对比），确定产生质量定量图像所需的平均施加应力（敏感性）和肿块硬度（评分）; 2）研究并量化可触及肿块表面下的深度对成像的影响（深度分辨率），研究平均施加应力对深度分辨率的影响，研究可触及肿块的性质;以及3）对具有结节结构的人造乳房执行与特定目的1和2中所述类似的分析，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、手持式筛查工具，用于早期检测乳腺癌，可以对肿瘤的可触知性及其与周围组织的附着性质进行成像，这将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，并避免不必要的乳腺X线摄影辐射暴露。具有肿块的大小、硬度和可触知性的定量图像将提供一组正交测量，其将显著改善临床乳腺检查（CBE）的程序并提高特异性，即，低假阳性，帮助医生做出明智的决定，在乳腺癌的最早阶段进行进一步的测试和启动治疗。

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.