Laboratory of Ion Channel Research, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium; Department of Urology, University Hospitals Leuven, Leuven, Belgium.
Department of Urology, Institute Paoli-Calmettes Cancer Centre, Marseille, France.
Eur Urol Focus. 2024 Jan;10(1):32-40. doi: 10.1016/j.euf.2023.07.001. Epub 2023 Jul 24.
This study evaluated the safety and performance of a drop-in gamma probe for prostate cancer (PCa) sentinel lymph node biopsy (SeLNB) in a prospective, open-label, multicentre, single-arm clinical trial.
The main objective was to determine the sentinel lymph node (SeLN) detection rate with the drop-in gamma probe system. The secondary objectives were overall performance and safety.
DESIGN, SETTING, AND PARTICIPANTS: At three European centres, patients received an ultrasound-guided systemic and tumour-targeted injection of [Tc]Tc-nanocolloid followed by planar lymphoscintigraphy and/or single-photon emission computerised tomography. The next day, manual laparoscopic or robot-assisted radical prostatectomy was performed, including SeLN dissection (SeLND) and extended pelvic lymph node dissection (ePLND).
SeLNs were detected with the drop-in probe and a rigid laparoscopic gamma probe (RLGP). The primary endpoint of the study was the SeLND rate defined as the percentage of patients with at least one SeLN detected in vivo by the drop-in probe. The secondary endpoints included diagnostic performance, ease of SeLN detection, number of SeLNs detected, and safety. The first two patients at each site (six in total) were used for familiarisation.
A total of 27 patients were included in the main analysis. SENSEI successfully detected at least one SeLN in all 27 patients, resulting in a detection rate of 100% (95% confidence interval 87.2-100%). The total number of SeLNs identified with SENSEI was 85 (median three SeLNs per patient, range 1-6); of these 85 SeLNs, 12 were located outside of the ePLND template. In the nine patients in whom the RLGP was used, SENSEI detected two SeLNs that could not be detected with the RLGP due to manoeuvrability restrictions. Ten of the 27 patients were pN1; four patients had a false-negative SeLNB. No adverse events or complications were related to the use of the drop-in probe.
The study demonstrated that the drop-in gamma probe meets the performance and safety requirements for SeLNB in PCa. The device provided improved manoeuvrability and SeLN detection compared with the conventional RLGP.
A novel device was tested for detecting sentinel lymph nodes during minimally invasive surgery for prostate cancer. In this first evaluation, the performance and safety of the device were evaluated positively.
本研究评估了一款用于前列腺癌（PCa）前哨淋巴结活检（SeLNB）的即插即用伽马探针的安全性和性能，这是一项前瞻性、开放标签、多中心、单臂临床试验。
主要目的是确定即插即用伽马探针系统的前哨淋巴结（SeLN）检出率。次要目标是评估整体性能和安全性。
设计、地点和参与者：在三个欧洲中心，患者接受了超声引导的全身和肿瘤靶向[Tc]Tc-纳米胶体注射，随后进行平面淋巴闪烁显像和/或单光子发射计算机断层扫描。第二天，进行手动腹腔镜或机器人辅助根治性前列腺切除术，包括前哨淋巴结解剖（SeLND）和扩展盆腔淋巴结清扫术（ePLND）。
使用即插即用探针和刚性腹腔镜伽马探针（RLGP）检测 SeLNs。该研究的主要终点是 SeLND 率，定义为通过即插即用探针在体内检测到至少一个 SeLN 的患者百分比。次要终点包括诊断性能、SeLN 检测的容易程度、检出的 SeLN 数量和安全性。每个中心的前两名患者（共 6 名）用于熟悉操作。
共有 27 名患者纳入主要分析。SENSEI 成功地在所有 27 名患者中检测到至少一个 SeLN，检出率为 100%（95%置信区间 87.2-100%）。使用 SENSEI 共检出 85 个 SeLNs（中位数每位患者 3 个 SeLNs，范围 1-6）；其中 85 个 SeLNs中有 12 个位于 ePLND 模板之外。在使用 RLGP 的 9 名患者中，SENSEI 检测到 2 个由于操作限制无法用 RLGP 检测到的 SeLNs。27 名患者中有 10 名 pN1；4 名患者有假阴性 SeLNB。与使用即插即用探针相关的不良事件或并发症。
研究表明，即插即用伽马探针满足 PCa 前哨淋巴结活检的性能和安全性要求。与传统 RLGP 相比，该设备提供了更好的操作灵活性和 SeLN 检测能力。
一种新型设备用于检测前列腺癌微创手术期间的前哨淋巴结。在首次评估中，该设备的性能和安全性得到了积极评价。
