Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer

Study Overview
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Brief Summary
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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

Official Title
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Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: SENSEI®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Familiarisation<br>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. | Device: SENSEI®<br>* SENSEI® laparoscopic tethered gamma probe is an intra-operative laparoscopic gamma probe system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Length of study finish - 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Diagnostic performance include sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV). Histopathological tumour status of lymph nodes excised based on the ePLND template will be used as reference standard. | Length of study finish - 6 Months | 
| Overall ease of use of the SENSEI® laparoscopic tethered gamma probe. |  | Length of study finish - 6 Months | 
| Radiation safety measurements for the staff. |  | Length of study finish - 6 Months | 
| Duration of surgery | Outcome will be measured from the first skin incision to skin closure (skin to skin). | Length of study finish - 6 Months | 
| In centres using a conventional rigid laparoscopic gamma probe: | SLN detection rate, number of SLNs, 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. 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 | 
| 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 | 
| Complication rate as measured by Clavien-Dindo classification |  | 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 | Outcome will be assessed using questionnaire and ethnographic observations, and at similar time points. | Length of study finish - 6 Months | 
| Duration of Sentinel Lymph Node Biopsy separately for each probe used | Duration of SLNB will be measured from the first in vivo measurement to completion of ex vivo measurements of excised SLN specimens and measured separately for each probe used. The end time of ex vivo measurements of the excised ePLND specimens will also be recorded. | Length of study finish - 6 Months | 
| Sentinel Lymph Node detection Rate | The 95% Confidence Interval (CI) around the detection rate will allow an estimate of the true detection rate. The sample size directly impacts the precision of the estimate. The sample size of 40 evaluable patients has been selected to provide a reasonable level of precision for the estimate of the SLN detection rate | Length of study finish - 6 Months | 
| Number of Sentinel Lymph Nodes | 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 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 |