Department of Gynecology and Obstetrics, University Breast Unit, Heidelberg, Germany.
Siemens Healthcare GmbH, Forchheim, Germany.
Arch Gynecol Obstet. 2021 Aug;304(2):559-566. doi: 10.1007/s00404-021-06081-z. Epub 2021 May 10.
The FUSION-X-US-II prototype was developed to combine 3D-automated breast ultrasound (ABUS) and digital breast tomosynthesis in a single device without decompressing the breast. We evaluated the technical function, feasibility of the examination workflow, image quality, breast tissue coverage and patient comfort of the ABUS device of the new prototype.
In this prospective feasibility study, the FUSION-X-US-II prototype was used to perform ABUS in 30 healthy volunteers without history of breast cancer. The ABUS images of the prototype were interpreted by a physician with specialization in breast diagnostics. Any detected lesions were measured and classified using BI-RADS scores. Image quality was rated subjectively by the physician and coverage of the breast was measured. Patient comfort was evaluated by a questionnaire after the examination.
One hundred and six scans were performed (61 × CC, 23 × ML, 22 × MLO) in 60 breasts. Image acquisition and processing by the prototype was fast and accurate. Breast coverage by ABUS was approximately 90.8%. Sixteen breast lesions (all benign, classified as BIRADS 2) were identified. The examination was tolerated by all patients.
The FUSION-X-US-II prototype allows a rapid ABUS scan with mostly high patient comfort. Technical developments resulted in an improvement of quality and coverage compared to previous prototype versions. The results are encouraging for a test of the prototype in a clinical setting in combination with tomosynthesis.
开发 FUSION-X-US-II 原型机，以在不压迫乳房的情况下将三维自动乳房超声（ABUS）和数字乳腺断层合成技术结合在一个设备中。我们评估了新原型的 ABUS 设备的技术功能、检查工作流程的可行性、图像质量、乳房组织覆盖范围和患者舒适度。
在这项前瞻性可行性研究中，使用 FUSION-X-US-II 原型机对 30 名无乳腺癌病史的健康志愿者进行 ABUS 检查。原型机的 ABUS 图像由具有乳腺诊断专业知识的医生进行解读。使用 BI-RADS 评分对任何检测到的病变进行测量和分类。医生对图像质量进行主观评估，并测量乳房覆盖范围。检查后通过问卷调查评估患者舒适度。
在 60 个乳房中进行了 106 次扫描（61×CC、23×ML、22×MLO）。原型机的图像采集和处理快速准确。ABUS 的乳房覆盖率约为 90.8%。共发现 16 个乳房病变（均为良性，分类为 BIRADS 2）。所有患者均能耐受检查。
FUSION-X-US-II 原型机允许快速进行 ABUS 扫描，患者舒适度高。技术改进使质量和覆盖范围得到了提高，与之前的原型版本相比有所改善。这些结果为在与断层合成技术联合的临床环境中测试原型机提供了令人鼓舞的结果。
