From the Departments of Surgery (J.W.J.), Radiology (G.K.H., M.W.U., C.U.L.), Quantitative Health Sciences, Division of Clinical Trials and Biostatistics (N.B.L.), Orthopedic Surgery (M.J.Y., A.L.M.), and Physiology and Biomedical Engineering (J.F.G., M.W.U.), Mayo Clinic, 4500 San Pablo Blvd, Jacksonville, FL 32224.
Radiol Imaging Cancer. 2022 Nov;4(6):e220053. doi: 10.1148/rycan.220053.
Purpose To evaluate the short-term safety of a nonmetallic twinkle marker and compare its conspicuity at color Doppler US with that of standard breast biopsy clips and radioactive seeds by using B-mode US in axillary lymph nodes. Materials and Methods This prospective study (November 2020-July 2021) of participants with node-positive breast cancer who completed chemotherapy involved placing a twinkle marker at the time of preoperative radioactive seed localization. A five-point scoring system (1 = easiest, 5 = most difficult) was used to rate the ease of identifying the clip, seed, and twinkle marker on postlocalization sonograms, mammograms, specimen radiographs, and gross pathologic specimens. Descriptive statistics were used. Results Eight women (mean age, 57 years ± 16 [SD]) were enrolled. The median scores for US conspicuity of each device were 3.9 (range, 3.7-5.0) for the radioactive seed, 2.4 (range, 1.0-5.0) for the clip, and 2.0 (range, 1.0-4.3) for the twinkle marker. In six of eight participants, the twinkle marker was the most identifiable at US. The seeds, clips, and twinkle markers were scored "very easy" to identify on seven of eight postlocalization mammograms. The surgeon retrieved all eight twinkle markers 1-3 days after localization. In all 16 interpretations, the seeds, clips, and twinkle markers were rated as very easy to identify on specimen radiographs. The clip was the most difficult device to identify at pathologic examination in all participants, and the twinkle marker was the easiest to identify in seven of eight participants. Conclusion This pilot study demonstrates that the safety and ease of US detection of a twinkling tissue marker may be comparable to a biopsy clip. Ultrasonography, US-Doppler, Breast, Localization, Surgery Clinical trial registration no. NCT04674852 © RSNA, 2022.
目的 评估一种非金属闪烁标记物的短期安全性,并通过 B 型超声在腋窝淋巴结中比较其与标准乳腺活检夹和放射性种子的彩色多普勒超声显影效果。
材料与方法 本研究为前瞻性研究(2020 年 11 月至 2021 年 7 月),纳入了完成化疗的淋巴结阳性乳腺癌患者,在术前放射性种子定位时放置闪烁标记物。采用 5 分制评分系统(1=最容易,5=最难)对定位后超声、乳房 X 线摄影、标本 X 线片和大体病理标本上夹、种子和闪烁标记物的识别难度进行评分。采用描述性统计学方法。
结果 共纳入 8 名女性(平均年龄,57 岁±16[标准差])。每个设备的超声显影中位评分分别为放射性种子 3.9 分(范围,3.7-5.0 分)、夹 2.4 分(范围,1.0-5.0 分)和闪烁标记物 2.0 分(范围,1.0-4.3 分)。在 8 名参与者中的 6 名,闪烁标记物在超声检查中最易识别。在 8 名参与者中的 7 名,7 名中的 8 次定位后乳房 X 线摄影检查中,种子、夹和闪烁标记物均被评为“非常容易”识别。外科医生在定位后 1-3 天内取回了 8 个闪烁标记物。在所有 16 次解读中,种子、夹和闪烁标记物在标本 X 线片上的识别度均被评为“非常容易”。在所有参与者中,夹是最难识别的器械,而在 7 名参与者中,闪烁标记物是最容易识别的。
结论 本初步研究表明,闪烁组织标记物的超声检测安全性和易检测性可能与活检夹相当。超声,超声多普勒,乳腺,定位,手术临床试验注册号 NCT04674852 © RSNA,2022.