Abascal Junquera Jose M, Harke Nina N, Walz Jochen C, Hadaschik Boris, Adshead Jim, Everaerts Wouter, Goffin Karolien, Grootendorst Maarten R, Oldfield Francesca, Vyas Kunal, Fusco Antoni Mestre, Juanpere Nuria, Vidal-Sicart Sergi, Fumado Lluis
From the Department of Urology, Hospital Del Mar, Barcelona, Spain.
Department of Urology, Hannover Medical School, Hannover, Germany.
Clin Nucl Med. 2023 Mar 1;48(3):213-220. doi: 10.1097/RLU.0000000000004557. Epub 2023 Jan 14.
This study evaluated the performance of a drop-in gamma probe for prostate cancer (PCa) sentinel lymph node dissection (SLND) in a pelvic phantom, porcine model, and in PCa patients as part of an ongoing prospective multicenter clinical trial.
Two design variants of the drop-in gamma probe (SENSEI; Lightpoint Medical Ltd) were assessed in the pelvic phantom, and the preferred design was evaluated in a porcine model with clinically representative volumes and 99mTc activities. In the clinical trial, radical prostatectomy, SLND, and extended pelvic lymph node dissection were performed the day after 99mTc-nanocolloid injection and imaging. Sentinel lymph nodes (SLNs) were detected with the drop-in probe and a rigid laparoscopic gamma probe (RLGP). An interim analysis was performed after 10 patients were recruited.
The narrow field of view probe design outperformed the wide field of view design in the pelvic phantom (detection rate, 100% vs 50%). In the porcine model, all activity concentrations could be successfully detected. The drop-in gamma probe successfully detected SLNs in all 10 patients (detection rate, 100%). Two of the SLNs identified by the drop-in gamma probe could not be found with the RLGP. No false-negative cases and no adverse events related to the SLND procedure or the drop-in gamma probe occurred.
The drop-in gamma probe meets the usability and performance requirements for SLND in PCa and provides performance advantages over the RLGP. The final clinical study results will confirm the performance of the technique across multiple sites.
作为一项正在进行的前瞻性多中心临床试验的一部分，本研究评估了一种插入式γ探测器在盆腔模型、猪模型以及前列腺癌（PCa）患者中用于前列腺癌前哨淋巴结清扫术（SLND）的性能。
在盆腔模型中评估了插入式γ探测器（SENSEI；Lightpoint Medical Ltd）的两种设计变体，并在具有临床代表性体积和99mTc活度的猪模型中评估了首选设计。在临床试验中，于99mTc-纳米胶体注射和成像后次日进行根治性前列腺切除术、SLND和扩大盆腔淋巴结清扫术。使用插入式探测器和刚性腹腔镜γ探测器（RLGP）检测前哨淋巴结（SLN）。在招募10名患者后进行中期分析。
在盆腔模型中，窄视野探测器设计的表现优于宽视野设计（检测率分别为100%和50%）。在猪模型中，所有活度浓度均能成功检测到。插入式γ探测器在所有10名患者中均成功检测到SLN（检测率为100%）。插入式γ探测器识别出的2个SLN用RLGP未找到。未发生假阴性病例，也未发生与SLND手术或插入式γ探测器相关的不良事件。
插入式γ探测器满足PCa中SLND的可用性和性能要求，且与RLGP相比具有性能优势。最终临床研究结果将证实该技术在多个地点的性能。
