目的:我们已经研究了使用聚甲基丙烯酸甲酯(PMMA)作为替代活检标记,在体外的情况下,可以通过超声多普勒闪烁很容易地检测到,离体,或在体内设置有限的持续时间。这项研究调查了在6个月动物实验中局部扰动和不同停留时间后,PMMA乳腺活检标记物的长期安全性和超声多普勒闪烁检测能力。
方法:本研究,这是由我们的机构动物护理和使用委员会批准的,涉及三头猪,并利用各种标记,包括PMMA(ZimmerBiomet),3D打印,和TumarkQ标记。每只猪在不同时间植入标记物。使用网状材料或乙醇在某些标志物附近诱导局部炎症反应。半定量闪烁评分评估了每月超声检查中可操作定位的闪烁。在主端点,使用可检测的标志物对淋巴结进行超声引导定位.手术切除局部结节后,进行组织形态计量学分析以评估组织向内生长和标记物周围组织外皮的形成。
结果:无不良事件发生。所有三只猪的所有标记的闪烁分数随时间逐渐降低。Q标记表现出最高的平均闪烁得分,其次是PMMA标记,带网眼的PMMA,和Q与乙醇。具有网格的3D打印标记和具有乙醇的PMMA的得分最低。所有钢丝定位淋巴结均成功切除。尽管标记物周围的组织外皮百分比不同,并且随着时间的推移整体闪烁显着减少(p<0.001),使用GeneralElectricC1-6探针和9L探针,平均PMMA闪烁评分在6个月和5个月时保持临床可操作,分别。
结论:在该猪模型中,PMMA标记物显示出可接受的安全性。即使在猪淋巴结中停留6个月后,临床上可操作的闪烁也有助于PMMA标记的检测。与所研究的所有其他标记物相比,Q标记物随时间保持最大的闪烁。
OBJECTIVE: We have studied the use of polymethyl methacrylate (PMMA) as an alternative biopsy marker that is readily detectable with ultrasound Doppler twinkling in cases of in vitro, ex vivo, or limited duration in vivo settings. This study investigates the long-term safety and ultrasound Doppler twinkling detectability of a PMMA breast biopsy marker following local perturbations and different dwell times in a 6-mo animal experiment.
METHODS: This study, which was approved by our Institutional Animal Care and Use Committee, involved three pigs and utilized various markers, including PMMA (Zimmer Biomet), 3D-printed, and Tumark Q markers. Markers were implanted at different times for each pig. Mesh material or ethanol was used to induce a local inflammatory reaction near certain markers. A semiquantitative twinkling score assessed twinkling for actionable localization during monthly ultrasounds. At the primary endpoint, ultrasound-guided localization of lymph nodes with detectable markers was performed. Following surgical resection of the localized nodes, histomorphometric analysis was conducted to evaluate for tissue ingrowth and the formation of a tissue rind around the markers.
RESULTS: No adverse events occurred. Twinkling scores of all markers for all three pigs decreased gradually over time. The Q marker exhibited the highest mean twinkling score followed by the PMMA marker, PMMA with mesh, and Q with ethanol. The 3D-printed marker with mesh and PMMA with ethanol had the lowest scores. All wire-localized lymph nodes were successfully resected. Despite varying percentages of tissue rind around the markers and a significant reduction in overall twinkling (p < 0.001) over time, mean PMMA twinkling scores remained clinically actionable at 6 and 5 mo using a General Electric C1-6 probe and 9L-probe, respectively.
CONCLUSIONS: In this porcine model, the PMMA marker demonstrates an acceptable safety profile. Clinically actionable twinkling aids PMMA marker detection even after 6 mo of dwell time in porcine lymph nodes. The Q marker maintained the greatest twinkling over time compared to all the other markers studied.