Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 56
- 试验地点
- 8
- 主要终点
- Sentinel lymph node (SLN) detection rate with the SENSEI® laparoscopic tethered gamma probe. Detection rate is defined as the percentage of patients with at least one SLN detected intraoperatively.
研究概览
简要总结
This study is a prospective, open label, single-arm study to examine the performance and safety of the SENSEI® laparoscopic tethered gamma probe in patients undergoing 99mTc-nanocolloid SLNB for prostate cancer (PCa) during RP and ePLND surgery.
Patients scheduled for RP and ePLND using the standard treatment pathways at each centre will have preoperative 99mTc-nanocolloid imaging. RP and ePLND will be conducted as standard of care, with SLNB guided by the SENSEI® laparoscopic tethered gamma probe carried out after RP and prior to ePLND. The first 2 patients per site (N = 10 in total) are considered to be sufficient to enable further familiarisation with the procedure and use of the probe in addition to the usability work and training that the sites did prior to the start of this study. Subsequent patients will be evaluable for the PP population. The primary analysis of diagnostic performance will be performed using the PP population of patients with SLN identified on preoperative imaging
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects who are ≥ 18 years of age with histologically proven prostate cancer; and who have signed an informed consent form prior to any study related activity • Subjects who are scheduled for radical prostatectomy with ePLND.
排除标准
- •Subjects who have received prior prostate cancer treatment or prior pelvic surgery;
- •Subjects who have an existing medical condition that would compromise their participation in the study;
- •Subjects with a history of hypersensitivity to 99mTc-nanocolloid or any excipients;
- •Subjects who are unable to give voluntary, written informed consent to participate in this study;
- •Subjects who are unable to understand this study and are not willing to complete all the study assessments.
结局指标
主要结局
Sentinel lymph node (SLN) detection rate with the SENSEI® laparoscopic tethered gamma probe. Detection rate is defined as the percentage of patients with at least one SLN detected intraoperatively.
时间窗: Length of study finish - 6 Months
次要结局
- Radiation safety measurements for the staff.(Length of study finish - 6 Months)
- Duration of surgery(Length of study finish - 6 Months)
- In centres using a conventional rigid laparoscopic gamma probe:(Length of study finish - 6 Months)
- In centres using a conventional rigid laparoscopic gamma probe: Overall ease of use of the conventional rigid laparoscopic gamma probe(Length of study finish - 6 Months)
- Sentinel Lymph Node detection Rate(Length of study finish - 6 Months)
- Duration of Sentinel Lymph Node Biopsy separately for each probe used(Length of study finish - 6 Months)
- Comparison of detection rates between robotic, open and manual laparoscopic surgery(Length of study finish - 6 Months)
- Incidence of study-related Adverse Events(Length of study finish - 6 Months)
- Number of SLNs detected with the SENSEI® laparoscopic tethered gamma probe in comparison to preoperative planar LS and SPECT/CT in centres with a SPECT/CT scanner.(Length of study finish - 6 Months)
- Diagnostic performance of the SENSEI® laparoscopic tethered gamma probe for detecting SLNs(Length of study finish - 6 Months)
- Overall ease of use of the SENSEI® laparoscopic tethered gamma probe.(Length of study finish - 6 Months)
- Complication rate as measured by Clavien-Dindo classification(Length of study finish - 6 Months)
- Number of Sentinel Lymph Nodes(Length of study finish - 6 Months)
- Diagnostic performance and in vivo and ex vivo count rate of the SENSEI® laparoscopic tethered gamma probe in comparison to the conventional rigid laparoscopic gamma probe.(Length of study finish - 6 Months)