Papa Moshe, Allweis Tanir, Karni Tami, Sandbank Judith, Konichezky Myriam, Diment Judith, Guterman Assaf, Shapiro Moshe, Peles Zachi, Maishar Roi, Gur Assaf, Kolka Eyal, Brem Rachel
Assuta Medical Center, Tel-Aviv, Israel.
Sackler School of Medicine, Tel Aviv University, Tel-Aviv, Israel.
J Surg Oncol. 2016 Jul;114(1):22-6. doi: 10.1002/jso.24246. Epub 2016 Apr 15.
BACKGROUND AND OBJECTIVES: One of the major unmet needs in Breast Conserving Surgery (BCS) is a rapid and accurate margin assessment of the lumpectomy specimen. This study evaluates the ability of a novel MRI system (prototype of the ClearSight™ system; Clear-Cut Medical Ltd., Rehovot, Israel) to distinguish malignant and non-malignant tissues in freshly excised breast specimen by comparing MR measurements to histopathology results. METHODS: Seventy-seven samples were obtained from 22 patients undergoing BCS enrolled in the study. A T2* (T2 Star) value in milliseconds (ms) was calculated for each sample and correlated with histopathology results. RESULTS: Of the 77 samples, 35 samples were classified by histopathology as malignant and 42 as non-malignant. T2* values were significantly higher in malignant samples compared to non-malignant samples (15.3 ± 2.72 ms and 10.6 ± 1.47 ms, respectively [P < 0.00001]). Analysis for a determined cutoff of 11.7 ms revealed 91% sensitivity, 93% specificity, and 92% accuracy. ROC curve analysis yielded AUC of 0.97. CONCLUSIONS: This study demonstrates that the system is sensitive and specific in differentiating malignant and non-malignant tissues in freshly excised breast specimen. The system has the potential to be used for breast specimen margin assessment during BCS, with the goal of decreasing the need for re-operation. J. Surg. Oncol. 2016;114:22-26. © 2016 Wiley Periodicals, Inc.
背景与目的:保乳手术(BCS)中尚未满足的主要需求之一是对肿块切除标本进行快速准确的切缘评估。本研究通过将磁共振测量结果与组织病理学结果进行比较,评估一种新型磁共振成像系统(ClearSight™系统原型;Clear-Cut Medical Ltd.,以色列雷霍沃特)区分新鲜切除乳腺标本中恶性和非恶性组织的能力。 方法:从纳入研究的22例行BCS的患者中获取77个样本。计算每个样本的T2*(T2星)值(单位为毫秒),并与组织病理学结果相关联。 结果:77个样本中,组织病理学分类为恶性的有35个,非恶性的有42个。恶性样本的T2*值显著高于非恶性样本(分别为15.3±2.72毫秒和10.6±1.47毫秒[P<0.00001])。对确定的截断值11.7毫秒进行分析,结果显示灵敏度为91%,特异性为93%,准确率为92%。ROC曲线分析得出AUC为0.97。 结论:本研究表明,该系统在区分新鲜切除乳腺标本中的恶性和非恶性组织方面具有敏感性和特异性。该系统有潜力用于BCS期间的乳腺标本切缘评估,目标是减少再次手术的需求。《外科肿瘤学杂志》2016年;114:22 - 26。©2016威利期刊公司。
Eur J Surg Oncol. 2004-4
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