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: 10230372
• 负责人: calin caluser
• 金额: $ 5.5万
• 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/10230372
• 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.

摘要： 该项目需要开发一个位置跟踪系统， 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，以避免遗漏小的乳腺癌。扫描整个乳房 近年来，乳腺癌筛查的兴趣越来越大，因为研究表明， 在有密集乳房X线照片的妇女中进行补充筛查可以显著增加 小癌症的检出率。虽然检测亚厘米病变是必不可少的， 成功治疗乳腺癌，结果表明，大约一半的病变较小， 经验丰富的操作员无法检测到超过9 mm的缺陷12。这一重大缺陷可能 部分原因是由于操作员的不精确导致乳房扫描不完整 视觉估计以及手术期间乳房的大规模变形。的 所产生的定位误差可以是几厘米的量级 扫描乳房的缺失区域的可能性。当前手持式超声系统 无法跟踪和记录扫描的完整性，也无法提醒操作员 扫描不完整Metritrack Inc.开发了一种专有的方法， 乳腺超声图像被纳入其FDA批准的自动乳腺 超声系统BVN G-1000。拟议的项目旨在制定一种评估方法， 乳腺超声扫描的体积完整性，基于专有的 映射方法和获得的临床数据。该项目分为两个目标。为 目标1，我们将建立一个软件应用程序，旨在自动检测乳房区域 没有最佳覆盖率，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的情况下检测乳房区域的准确性和精确性。 为此，定制了具有多个小内部目标的超声乳腺体模， 模拟的小肿瘤将在不同的变形条件下建立和扫描， 由2名操作员模拟临床使用条件。我们希望本阶段的成果 1项目将论证建筑物扫描验证的完整性的可行性 和引导应用到自动乳房超声系统中，以克服 乳腺超声的局限性。该原型将被开发成一个商业 成功的产品，提供标准化，完整的乳腺超声检查的整体 乳腺癌的检出率比现在更高。