Hand-held optical imager for breast cancer imaging

描述(由申请人提供)：乳腺癌的早期诊断对于提高美国受影响妇女的存活率(八分之一)至关重要。近红外(NIR)光学成像是一种非侵入性和非电离的成像方式，正在成为乳腺癌的一种诊断工具。近年来，手持式光学成像仪向临床推广该技术，不能沿着组织曲率绘制轮廓，也不能执行三维(3D)断层成像来诊断深层和/或早期肿瘤。这项拟议工作的总体目标是实施最近开发的基于CART的便携式手持式光学成像仪，用于组织模型和活体乳腺成像研究(在正常和乳腺癌受试者中)，以演示近实时的2D肿瘤检测和3D断层分析，用于乳腺癌诊断。具体目标包括：(I)使用一种新型手持式光学成像器，在组织模体和活体中实时同时进行双侧乳房成像，以便近乎实时地检测模拟肿瘤的目标。(Ii)通过使用手持光学成像仪的3D断层成像研究，证明在组织模体和体内进行3D目标定位的可行性；以及(Iii)与黄金标准的X光乳房X光照相比较，确定使用手持光学成像仪在乳腺癌受试者中检测肿瘤的有效性。该应用程序的假设依赖于三重创新实施：(I)“分叉”探头设计有助于同时对两个乳房组织进行双侧成像，以提高正常组织和病变组织之间的信噪比；(Ii)使用手持探头对任何组织的体积和曲率进行联合配准测量，有助于近实时目标检测以及3D断层成像；以及(Iii)组织上多个位置的同时照明和检测将允许快速成像时间，适合临床环境。研究设计涉及以下内容：(I)对乳房模体、健康受试者和乳腺癌受试者体内同时进行双侧成像，以确定具有最大信噪比的2D靶点(肿瘤)可探测性的有效性。(Ii)实施共同配准的成像方法，以获得探头(S)的位置信息，用于体模和活体的3D断层分析。(Iii)通过体模和活体断层分析确定3D靶点(肿瘤)位置(S)；及(Iv)将光学图像与乳腺癌研究中的黄金标准X射线乳房X光图像进行比较，以评估手持光学成像仪在临床环境中的可行性。这项拟议的研究加速了新兴光学成像技术向早期乳腺癌诊断的临床转化，这是因为使用便携式和廉价的手持光学成像仪进行3D目标定位的独特和创新方法。这项技术还有可能用于预测预后的乳房成像、图像引导的乳腺癌治疗，以及对化疗试验做出反应的肿瘤的体积分析。

DESCRIPTION (provided by applicant): Early-stage diagnosis of breast cancer is essential for improving the survival rate of women affected (1 in 8) in the United States. Near-infrared (NIR) optical imaging is a non-invasive and non-ionizing modality that is emerging as a diagnostic tool for breast cancer. In recent years, hand-held based optical imagers developed towards clinical translation of the technology are not capable of contouring along tissue curvatures, nor perform three-dimensional (3D) tomographic imaging to diagnose deep and/or early stage tumors. The overall objective of the proposed work is to implement the recently developed portable cart-based hand-held optical imager for tissue phantom and in-vivo breast imaging studies (in normal and breast cancer subjects), in order to demonstrate near-real time 2D tumor detection and 3D tomographic analysis, towards breast cancer diagnosis. The specific aims include: (i) Demonstrate real-time simultaneous bilateral breast imaging in tissue phantoms and in-vivo, using a novel hand-held optical imager, in order to detect tumor-mimicking targets in near real-time. (ii) Demonstrate the feasibility of 3D target localization in tissue phantoms and in-vivo, via 3D tomographic imaging studies using the hand-held optical imager; and (iii) Determine the effectiveness of tumor detection in breast cancer subjects using the hand-held optical imager, in comparison to the gold-standard x- ray mammography. The hypothesis of the application relies on a three-fold innovative implementation: (i) the "forked" probe design aids in performing simultaneous bilateral imaging of both the breast tissues, in order to improve the signal-to-noise (SNR) ratio between the normal and diseased tissue; (ii) co-registered measurements using a hand-held probe on any tissue volume and curvature aids in near real-time target detections as well as 3D tomographic imaging; and (iii) simultaneous illumination and detection at multiple locations on the tissue will allow rapid imaging time, appropriate for a clinical environment. The study design involves the following: (i) Perform simultaneous bilateral imaging on breast phantoms, in-vivo on healthy and breast cancer subjects to determine the effectiveness of 2D target (tumor) detectability with maximum SNR. (ii) Implement a coregistered imaging approach to obtain positional information of the probe(s) towards 3D tomographic analysis in phantom and in-vivo. (iii) Determine the 3D target (tumor) location(s) via tomographic analysis in phantoms and in-vivo; and (iv) Compare the optical images to the gold standard x-ray mammography images in breast cancer subject studies, in order to assess the feasibility of the hand-held optical imager in a clinical environment. The proposed research significantly impacts by accelerating the clinical translation of the emerging optical imaging technology towards early-stage breast cancer diagnosis, due to the unique and innovative method of 3D target localization using a portable and inexpensive hand-held optical imager. The technology also has potential towards prognostic breast imaging, image-guided breast cancer therapy, and volumetric analysis of tumors in response to chemotherapeutic trials.