USE OF A TACTILE BREAST IMAGER FOR MASS PRE-SCREENING

我们提出了一种新的触觉乳房成像仪（TBI），用于早期乳腺癌检测，旨在有效地进行低成本的大规模预筛查。该设备将建立在机械成像（MI）领域的发展基础上，MI是一种将组织的弹性特性转化为感兴趣区域组织的数字三维地图的方法。它不仅为临床使用提供了一种优越的方法，而且还提供了一种强大的筛查新范例，患者在家中收集数据并有效地将其传递给医生进行审查。正如本提案所示，基础技术已被证明可以产生远低于手动触诊可检测阈值的皮下病变图像。在这笔赠款下拟议的努力是证明这项技术可以纳入一种易于使用的形式，并确定可靠的数据收集所需的技能和培训要求。实现这一目标所需的关键发展分为两类：首先是检查程序的发展和设备功能的修改，以简化检查过程。以可靠的方式获得足够准确的数据的能力主要取决于三个方面：收集数据的程序，促进这一过程的设备设计，以及数据的后续处理，以尽量减少程序和解剖/生理变化的影响。虽然大多数必要的元素已经发展到足够的功能水平，但它们通常又大又麻烦，因此会妨碍TBI的易用性。TBI探针的小型化和产品化以及数据处理/传输组件的精细化是必要的。我们的目标是在原型TBI中实现这些发展，并评估病变检测的灵敏度，临床和家庭应用的有效性和易用性。在第一阶段的授权下，我们的目标是开发一种光学检查程序，一个合适的用户/TBI界面设计，以及强大的程序后数据处理算法，以便在最少的培训下获得可靠和敏感的数据。拟议的商业应用：拟议的TBI是一种易于使用的诊断工具，有可能有效地取代卫生保健专业人员的乳房自我检查。潜在的结果是，在检测到乳腺癌时，乳腺癌的体积会大大缩小，因此，治疗会更有效，患者发病率和死亡率会降低，保健费用也会降低。销售这款设备的潜在总收入是5.2亿美元。

We propose a new Tactile Breast Imager (TBI) for early breast cancer detection intended for effective low-cost mass pre-screening. The device will build on developments made in the field of mechanical imaging (MI), a method that translates the tissue's elastic properties into a digital 3-D map of the tissue in the region of interest. It enables not only a superior method for clinical use, but also a powerful new paradigm of screening in which the patient collects data at home and efficiently transfers it to her physician for review. As is shown in this proposal, the underlying technology has been demonstrated to yield images of subcutaneous lesions that are well below the threshold of detectability by manual palpation. The proposed effort under this grant is to demonstrate that this technology may be incorporated into an easy to use form and determine the requisite skill and training requirements for robust data collection. The key developments necessary to achieve this goal lie in two categories: First is the development of the examination procedure and modification of equipment functionality to simplify the examination process. The ability to acquire sufficiently accurate data in a reliable manner depends largely on three aspects: the procedure in which the data is collected, the design of the equipment to facilitate this process, and subsequent processing of the data to minimize the effects of procedural and anatomical/physiological variations. While the majority of the necessary elements have already been developed to an adequately functional level, they are generally large and cumbersome and so would impede the ease of use of the TBI. The miniaturization and productization of the TBI probe and refinement of the data processing/transfer components is necessary. We aim to implement these developments in a prototype TBI and evaluate the resulting sensitivity for lesion detection a effectiveness and ease of use for both the clinical and home-use applications. Under Phase I grant we aim to develop an optical examination procedure, a suitable user/TBI interface design, and robust post procedure data processing algorithms to allow reliable and sensitive data to be obtained with minimal training. PROPOSED COMMERCIAL APPLICATIONS: The proposed TBI is an easy-to-use diagnostic tool that has the potential to effectively replace breast self-examination by health care professionals. The potential result is a significant decrease of the size of breast cancers at detection and consequently, more effective treatment, decrease in patient morbidity and mortality, and reduced health care costs. The potential gross revenues on the sale of this device is $520,000,000.