IMAGING NETWORK FOR BREAST CANCER MASS SCREENING

描述（由申请人提供）： 乳腺癌的早期发现仍然是卫生保健领域最重大的挑战之一。触觉乳房成像仪（TBI）是一种很有前途的解决方案，它以电子方式捕获触觉，为触诊乳房检查提供定量、灵敏和永久的记录。其固有的低成本，易于使用，以及迄今为止有希望的测试结果，使其成为乳腺癌检测的有效大规模预筛查工具。 在第一阶段，我们成功地开发和测试了一个原型设备，在各种测试条件下显示出远远超过手动触诊限制的灵敏度。该设备在物理组织模型上进行了测试，并证明可以稳健地检测各种尺寸和皮下深度的结节。开发了先进的数据处理算法，提供了底层机械组织结构的生动3-D图像。 在第二阶段，我们将进行初步的临床研究，以获取原始图像数据和相关的病变机械特性数据，用于改进图像处理和特征识别能力。我们将同时建立一个先进的TBI原型，大大提高传感器的性能。临床研究将涉及同时进行的乳腺X线摄影/ TBI成像，并对模式进行定性比较分析。我们将开展临床开发研究并构建物理乳腺模型，以改善数据收集和病变识别性能。然后将在盲法临床研究中测试TBI，以获得病变灵敏度、特异性和机械图像质量的统计学相关指标。将进行适当的监管测试，以便为FDA申请准备必要的工程文件。

DESCRIPTION (provided by applicant): Early detection of breast cancer remains one of the most significant challenges in health care. The tactile breast imager (TBI) is a promising solution that electronically captures the sense of touch to provide a quantitative, sensitive, and permanent record of palpatory breast examination. Its inherent low cost, ease of use, and promising test results to date, give it great potential as an effective mass pre-screening tool for breast cancer detection. In Phase I, we successfully developed and tested a prototype device that showed sensitivity well beyond the manual palpation limit in a variety of test conditions. The device was tested on physical tissue models and demonstrated to robustly detect nodules of various sizes and subcutaneous depths. Advanced data processing algorithms were developed providing vivid 3-D images of the underlying mechanical tissue structure. In Phase II we will perform an initial clinical study to acquire raw image data and correlated lesion mechanical property data for use in refining the image processing and feature identification capabilities. We will concurrently build an advanced TBI prototype with substantially improved sensor performance. Clinical studies will be performed involving concurrent mammography / TBI imaging with qualitative comparative analysis between the modalities. We will conduct clinical development studies and build physical breast models to improve the data collection and lesion discrimination performance. The TBI will then be tested in a blinded clinical study to obtain statistically relevant measures of lesion sensitivity, specificity, and mechanical image quality. Appropriate regulatory testing will be conducted in order to prepare necessary engineering documentation for a FDA application.