Safety and Feasibility of Direct Magnetic Resonance Imaging-guided Transperineal Prostate Biopsy Using a Novel Magnetic Resonance Imaging-safe Robotic Device
Safety and Feasibility of Direct Magnetic Resonance Imaging-guided Transperineal Prostate Biopsy Using a Novel Magnetic Resonance Imaging-safe Robotic Device
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DOI：
10.1016/j.urology.2017.07.010
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发表时间：
2017-11-01
期刊：
影响因子：
2.1
通讯作者：
Allaf, Mohamad E.
中科院分区：
文献类型：
--
作者：
Ball, Mark W.;Ross, Ashley E.;Allaf, Mohamad E.
目的评估直接磁共振成像（MRI）引导下前列腺活检使用一种新型的机器人device.MrBot是一种MRI安全的机器人设备，完全由非导电，非金属和非金属材料和我们的小组开发的首次在人体试验的安全性和可行性。设计了一项安全性和可行性临床试验，以评估使用MrBot进行直接MRI引导活检的安全性和可行性，并确定其靶向准确性。前列腺特异性抗原水平升高、既往前列腺活检阴性和MRI上癌症可疑区域（CSR）的男性入选研究。针对CSR的活检，除了六分仪的位置，进行了performed.Results五名男子进行活检与MrBot。两名男子在手术后需要插入Foley导管，没有其他并发症或不良事件。尽管这不是一项旨在检测前列腺癌的研究，但活检证实了2例患者存在具有临床意义的癌症。在总共30个活检位点上，机器人实现了基于MRI的2.55 mm的靶向准确度和1.59 mm的垂直于针的精度，没有轨迹校正，也没有失败的尝试靶向site.Conclusion机器人辅助MRI引导下前列腺活检是安全可行的。这项研究证实，MRI中描绘的临床显著前列腺癌（>= 5 mm半径，0.5 cm（3））可以准确定位。在CSR中直接确认穿刺针放置可能比基于融合的技术更具优势，并对阴性活检结果更具信心。需要进行更多的研究来评估这种方法的有效性。(c)2017爱思唯尔公司
OBJECTIVE To evaluate safety and feasibility in a first-in-human trial of a direct magnetic resonance imaging (MRI)-guided prostate biopsy using a novel robotic device.METHODS MrBot is an MRI-safe robotic device constructed entirely with nonconductive, nonmetallic, and nonmagnetic materials and developed by our group. A safety and feasibility clinical trial was designed to assess the safety and feasibility of a direct MRI-guided biopsy with MrBot and to determine its targeting accuracy. Men with elevated prostate-specific antigen levels, prior negative prostate biopsies, and cancer-suspicious regions (CSRs) on MRI were enrolled in the study. Biopsies targeting CSRs, in addition to sextant locations, were performed.RESULTS Five men underwent biopsy with MrBot. Two men required Foley catheter insertion after the procedure, with no other complications or adverse events. Even though this was not a study designed to detect prostate cancer, biopsies confirmed the presence of a clinically significant cancer in 2 patients. On a total of 30 biopsy sites, the robot achieved an MRI-based targeting accuracy of 2.55 mm and a precision of 1.59 mm normal to the needle, with no trajectory corrections and no unsuccessful attempts to target a site.CONCLUSION Robot-assisted MRI-guided prostate biopsy appears safe and feasible. This study confirms that a clinically significant prostate cancer (>= 5-mm radius, 0.5 cm(3)) depicted in MRI may be accurately targeted. Direct confirmation of needle placement in the CSR may present an advantage over fusion-based technology and gives more confidence in a negative biopsy result. Additional study is warranted to evaluate the efficacy of this approach. (c) 2017 Elsevier Inc.