Evaluating the completeness of scanning in hand-held whole breast ultrasound exams

评估手持式全乳超声检查扫描的完整性

• 批准号: 10248630
• 负责人: calin caluser
• 金额: $ 0.06万
• 依托单位: METRITRACK, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-03-01 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10248630
• 关键词: Algorithms; Area; Breast; Breast Cancer Detection; Breast Cancer Treatment; Cancer Detection; Chest; Clinical; Clinical Data; Computer software; Custom; Detection; Development; Diagnosis; Feedback; Goals; Hand; Image; Lesion; Localized Lesion; Malignant Neoplasms; Mammary Ultrasonography; Mammography; Measures; Methods; Modification; Movement; Nipples; Operator Regions; Outcome; Peripheral; Phase; Population; Positioning Attribute; Procedures; Protocols documentation; Running; Scanning; Small Business Innovation Research Grant; Standardization; Surface; System; Technology; Testing; Time; Ultrasonics; Ultrasonography; Visual; Woman; Work; base; breast lesion; breast scan; design; experience; interest; malignant breast neoplasm; prevent; prototype; robotic system; screening; sensor; supplemental screening; tumor

ABSTRACT: The project entails the development of a position-tracking system compatible with existing hand-held ultrasound systems that can track the complete breast volume coverage with a sufficient level of precision to avoid missing small breast cancers. Scanning the entire breast for screening breast cancer gained increased interest in recent years, as it was shown that supplemental screening in women with dense mammograms can significantly increase the detection rate of small cancers. While detecting sub-centimeter lesions is essential for the successful treatment of breast cancer, it was shown that around half of all lesions smaller than 9 mm were not detected by experienced operators12. This significant shortcoming can be partly attributed to an incomplete scanning of the breast caused by operator's imprecise visual estimation and also by large-scale deformation of the breast during the procedure. The resultant localization error can be in the order of a few centimeters and will increase the likelihood of missing regions of the scanned breast. Current hand-held ultrasound systems cannot track and document completeness of scanning or alert operators of regions with incomplete scanning. Metritrack Inc. developed a proprietary method of mapping hand-held breast ultrasound images that was incorporated in its FDA-cleared automated breast ultrasound system BVN G-1000. The proposed project intends to develop a method to assess the volumetric completeness of breast ultrasound scanning, based on the proprietary mapping method and the obtained clinical data. The project is segmented into two aims. For aim 1, we will build a software application designed to automatically detect the breast regions without optimal coverage and guide the operator to obtaining a complete exam. Aim 2 will evaluate the accuracy and precision of detecting breast regions without optimal coverage. For this purpose, a customized ultrasound breast phantom with multiple small internal targets simulating small tumors will be built and scanned under different conditions of deformation, by 2 operators to simulate clinical conditions of use. We expect that the outcome of this Phase 1 project will demonstrate the feasibility of building the completeness of scanning verification and guidance application into an automated breast ultrasound system to overcome the current limitations of breast ultrasound. The prototype will be developed into a commercially successful product to provide standardized, complete breast ultrasound exams of the whole breast with a higher cancer detection rate than possible today.

抽象的： 该项目需要开发与现有的位置跟踪系统兼容的位置跟踪系统 手持式超声系统，可以跟踪完整的乳房体积覆盖范围 足够的精确度以避免遗漏小乳腺癌。扫描整个乳房 近年来，乳腺癌筛查引起了越来越多的关注，因为有研究表明 对进行密集乳房X光检查的女性进行补充筛查可以显着提高 小癌症的检出率。虽然检测亚厘米病变对于 乳腺癌的成功治疗表明，大约一半的病灶变小 经验丰富的操作员无法检测到超过 9 毫米12。这个显着的缺点可以 部分原因是操作者的不精确导致乳房扫描不完整 视觉估计以及手术过程中乳房的大规模变形。这 由此产生的定位误差可能约为几厘米，并且会增加 扫描乳房缺失区域的可能性。当前的手持式超声系统 无法跟踪和记录扫描的完整性或警告区域操作员 扫描不完整。 Metritrack Inc. 开发了一种专有的手持式测绘方法 乳房超声图像已纳入 FDA 批准的自动化乳房 超声系统 BVN G-1000。拟议项目旨在开发一种评估方法 基于专有技术的乳房超声扫描的体积完整性 绘图方法和获得的临床数据。该项目分为两个目标。为了 目标 1，我们将构建一个软件应用程序，旨在自动检测乳房区域 没有最佳覆盖范围并指导操作员获得完整的检查。目标2将 评估在没有最佳覆盖范围的情况下检测乳房区域的准确性和精确度。 为此，需要定制具有多个小型内部目标的超声乳腺模型 将建立模拟小肿瘤并在不同变形条件下进行扫描， 由 2 名操作员模拟临床使用条件。我们预计这一阶段的结果 1个项目将论证构建扫描验证完整性的可行性 和引导应用到自动化乳腺超声系统中，以克服 目前乳腺超声检查的局限性。该原型机将被开发成商业化的 成功的产品提供标准化、完整的乳腺整体超声检查 乳腺癌的癌症检出率比今天更高。