Low Cost Automated Ultrasound for Breast Cancer Detection and Diagnosis

描述(申请人提供)：乳腺癌是全世界女性癌症死亡的最常见原因，对于发展中国家的女性来说，这一数字高得不成比例。发展中国家需要低成本、便携的诊断工具，这些工具易于使用，不需要额外的专业人员就能发挥作用。我们提出了一种低成本、便携的自动化超声设备，其中包含软件来提高图像质量，并提供计算机辅助检测和诊断(CAD)来定位和区分明显良性和潜在恶性的可触及的乳腺肿块。虽然筛查在西方国家一直是诊断的重点，但乳腺癌通常出现在50岁以下的女性身上，在发展中国家表现为明显的肿块。这一年龄段常见的乳腺肿块类型(囊肿、纤维腺瘤、纤维囊性变和癌症)在超声上通常是明显的，在年轻女性中，不到10%代表恶性。我们的目标是开发一种设备，可以供当地的医疗援助机构使用，以确定哪些乳房肿块需要进行活组织检查，因为它们是可疑的，哪些可以不受影响。这将使紧张的医疗保健提供系统能够将资源集中在最有可能从她们的努力中受益的女性身上。为了给发展中国家的乳腺癌分诊提供一个有效的工具，我们建议做以下工作：1.介绍超声图像增强和计算机辅助检测与诊断(CAD)的新算法。这些算法利用实时超声扫描中可用的时间信息来确定恶性肿瘤的可能性。2.在加利福尼亚州进行的临床试验，以确定超声设备的灵敏度和特异度。在与发展中国家妇女相匹配的队列组上进行的临床试验将确定该技术的有效性。3.临床试验在LMIC环境中验证技术的有效性、可接受性和可行性临床试验将在墨西哥进行。这项工作是与乳腺癌专家和外科医生Susan Love博士，乳腺影像放射学家，临床试验专家文迪·伯格博士，医疗和软件产品开发和商业化专家，Christine Podilchuk博士，技术和商业化专家，Richard Mammone教授，以及外科教授和全球健康医学专家Ben Anderson博士的密切合作。

DESCRIPTION (provided by applicant): Breast cancer is the most common cause of cancer death among women worldwide and the numbers are disproportionately high for women in developing countries. Developing countries demand low-cost, portable diagnostic tools that are easy to use and do not require additional professional staff to be effective. We propose a low-cost, portable, automated ultrasound device containing software to improve the image quality and provide computer-aided detection and diagnosis (CAD) to locate and distinguish between clearly benign and potentially malignant palpable breast lumps. While screening has been the focus for diagnosis in western countries, breast cancer most commonly presents in women less than 50 years of age and as a palpable lump in developing countries. The common types of breast lumps in this age group (cysts, fibroadenomas, fibrocystic change and cancer) are usually distinct on ultrasound with fewer than 10% representing malignancy in young women. Our goal is to develop a device that could be used by a local health aid to determine which breast lumps need to be biopsied because they are suspicious and which can be left alone. This would enable stressed healthcare delivery systems to focus resources on the women most likely to benefit from their efforts. In order to provide an effective tool for breast cancer triage in developing countries we propose to do the following: 1. Introduce novel algorithms for ultrasound image enhancement and computer-aided detection and diagnosis (CAD). These algorithms take advantage of temporal information available in a live ultrasound scan to determine the probability of malignancy. 2. Clinical trial in California to determine the sensitiviy and specificity of the ultrasound device. A clinical trial on a cohort group that matches the women in developing countries will determine the effectiveness of the technology. 3. Clinical trial to validate effectiveness, acceptability and feasibility of technology in an LMIC environment The clinical trial will be performed in Mexico. This work is a close collaboration with breast cancer expert and surgeon, Dr. Susan Love, breast imaging radiologist, clinical trial expert Dr. Wendie Berg, medical and software product development and commercialization expert, Christine Podilchuk, PhD, technology and commercialization expert, Professor Richard Mammone, and professor of surgery and global health medicine expert, Dr. Ben Anderson.