IRCCS Ospedale Policlinico San Martino, Genova, Genoa, Italy.
IRCCS Ospedale Policlinico San Martino, Genova, Genoa, Italy; Department of Surgical Sciences and Integrated Diagnostic (DISC), University of Genoa, Genoa, Italy.
Clin Radiol. 2019 Dec;74(12):974.e1-974.e6. doi: 10.1016/j.crad.2019.08.004. Epub 2019 Sep 11.
To compare a standard intra-operative mammography (IM) device with digital breast tomosynthesis using a dedicated device (Mozart system) in the evaluation of surgical margins at first excision.
The study received institutional review board approval and written informed consent was obtained from participants. From January 2018 to December 2018, a prospective analysis of the images of IM device and intra-operative digital breast tomosynthesis with a dedicated device (Mozart system) in n=89 breast cancer patients (average patients age: 58 years, age range: 35-76 years) was undertaken. Images were evaluated by two expert breast radiologists independently of each other and blinded to each other's interpretation, who indicated the positive cases requiring surgical re-excision intra-operatively.
Mean cancer size was 12.5±4.5 mm. Radiological signs of the lesions were microcalcifications (n=71), nodules (n=10), and architectural distortions (n=8). A total of 20/89 (17%) patients underwent intra-operative re-excision for positive margins. Intra-operative digital breast tomosynthesis with a dedicated device and IM showed discrepancies in 15/89 cases (17%). Mozart system results informed the necessity to perform a re-excision (n=15). Overall, receiver operating characteristic (ROC) curve analysis showed and area under the ROC curve (AUC) of 0.82 for the Mozart system versus 0.65 for IM. ROC analysis of radiological findings with microcalcifications showed an AUC of 0.92 for the Mozart system versus 0.74 for IM, whereas AUC in cases with no microcalcifications were 0.87 and 0.75, respectively.
Intra-operative digital breast tomosynthesis with a dedicated device provides more information (better accuracy) than IM and facilitated a reduction in re-excision rates.
比较标准术中乳腺摄影（IM）设备与专用设备（Mozart 系统）下数字乳腺断层合成在首次切除时评估手术切缘的作用。
该研究获得了机构审查委员会的批准，并获得了参与者的书面知情同意。2018 年 1 月至 2018 年 12 月，前瞻性分析了 89 例乳腺癌患者（平均患者年龄：58 岁，年龄范围：35-76 岁）的 IM 设备和专用设备（Mozart 系统）术中数字乳腺断层合成的图像。两位专家乳腺放射科医师独立评估图像，彼此不了解对方的解释，并在术中指示需要再次手术切除的阳性病例。
平均癌症大小为 12.5±4.5mm。病变的放射学征象为微钙化（n=71）、结节（n=10）和结构扭曲（n=8）。共有 20/89（17%）例患者因阳性切缘而行术中再次切除。专用设备术中数字乳腺断层合成和 IM 显示差异 15/89 例（17%）。Mozart 系统结果提示需要进行再次切除（n=15）。总体而言，接收器工作特征（ROC）曲线分析显示 Mozart 系统的 ROC 曲线下面积（AUC）为 0.82，而 IM 的 AUC 为 0.65。ROC 分析显示，微钙化的放射学发现的 AUC 为 0.92，而 IM 的 AUC 为 0.74，而无微钙化的 AUC 分别为 0.87 和 0.75。
专用设备的术中数字乳腺断层合成提供了更多信息（更高的准确性），并降低了再次切除率。
