Abstract：
BACKGROUND: Evaluate whether the Breast Cancer Locator™ (BCL), a novel guidance system based on supine MRI images, can be safely and effectively deployed by several surgeons at multiple sites.
METHODS: Patients with palpable breast cancer underwent supine MRI at their local institution. A three dimensional (3D) digital image of the tumor in the breast was derived from supine MRI images and used to generate 1) an interactive 3D virtual image of the tumor in the breast (Visualizer) and 2) a plastic bra-like form that allowed the surgeon to place a central wire and bracketing wires in the breast (BCL). The primary objective was to determine the proportion of patients who had the central localization wire deployed within the cancer on specimen mammogram.
RESULTS: Fourteen patients were enrolled at 4 different sites by 6 surgeons. BCLs were successfully manufactured for all patients. The central wire was deployed within the tumor on specimen mammogram in 12 of the 13 patients who had a central wire placed (92%). The cancer was excised with negative margins in 14/14 cases (100%). No adverse events occurred.
CONCLUSIONS: Supine MRI image acquisition was accomplished successfully across multiple sites. Multiple surgeons utilized the BCL system to localize cancers accurately and safely.
METHODS: Patients with palpable breast cancer underwent supine MRI at their local institution. A three dimensional (3D) digital image of the tumor in the breast was derived from supine MRI images and used to generate 1) an interactive 3D virtual image of the tumor in the breast (Visualizer) and 2) a plastic bra-like form that allowed the surgeon to place a central wire and bracketing wires in the breast (BCL). The primary objective was to determine the proportion of patients who had the central localization wire deployed within the cancer on specimen mammogram.
RESULTS: Fourteen patients were enrolled at 4 different sites by 6 surgeons. BCLs were successfully manufactured for all patients. The central wire was deployed within the tumor on specimen mammogram in 12 of the 13 patients who had a central wire placed (92%). The cancer was excised with negative margins in 14/14 cases (100%). No adverse events occurred.
CONCLUSIONS: Supine MRI image acquisition was accomplished successfully across multiple sites. Multiple surgeons utilized the BCL system to localize cancers accurately and safely.
摘要：
背景：评估乳腺癌定位器™（BCL）一种基于仰卧MRI图像的新型引导系统，可以安全有效地部署在多个地点的几个外科医生。
方法：可触及的乳腺癌患者在当地机构接受仰卧位MRI检查。乳房肿瘤的三维（3D）数字图像来自仰卧MRI图像，用于生成1）乳房肿瘤的交互式3D虚拟图像（Visualizer）和2）塑料胸罩状形式允许外科医生在乳房中放置中心线和包围线（BCL）。主要目的是确定在标本乳房X线照片上在癌症内部署中央定位线的患者比例。
结果：由6名外科医生在4个不同部位招募了14名患者。为所有患者成功制造了BCL。在13位放置了中央线的患者中，有12位（92％）的中央线在标本乳房X线照片上部署在肿瘤内。14/14例(100%)切缘阴性。无不良事件发生。
结论：仰卧MRI图像采集在多个部位成功完成。多个外科医生利用BCL系统准确和安全地定位癌症。
方法：可触及的乳腺癌患者在当地机构接受仰卧位MRI检查。乳房肿瘤的三维（3D）数字图像来自仰卧MRI图像，用于生成1）乳房肿瘤的交互式3D虚拟图像（Visualizer）和2）塑料胸罩状形式允许外科医生在乳房中放置中心线和包围线（BCL）。主要目的是确定在标本乳房X线照片上在癌症内部署中央定位线的患者比例。
结果：由6名外科医生在4个不同部位招募了14名患者。为所有患者成功制造了BCL。在13位放置了中央线的患者中，有12位（92％）的中央线在标本乳房X线照片上部署在肿瘤内。14/14例(100%)切缘阴性。无不良事件发生。
结论：仰卧MRI图像采集在多个部位成功完成。多个外科医生利用BCL系统准确和安全地定位癌症。
