Clinical trial NCT04632251: Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer
Official title: Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Lightpoint Medical Limited
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Length of study finish - 6 Months
Secondary outcomes:
measure: 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.
timeFrame: Length of study finish - 6 Months
measure: Diagnostic performance of the SENSEI® laparoscopic tethered gamma probe for detecting SLNs
timeFrame: Length of study finish - 6 Months
measure: Overall ease of use of the SENSEI® laparoscopic tethered gamma probe.
timeFrame: Length of study finish - 6 Months
measure: Radiation safety measurements for the staff.
timeFrame: Length of study finish - 6 Months
measure: Duration of surgery
timeFrame: Length of study finish - 6 Months
measure: In centres using a conventional rigid laparoscopic gamma probe:
timeFrame: Length of study finish - 6 Months
measure: Comparison of detection rates between robotic, open and manual laparoscopic surgery
timeFrame: Length of study finish - 6 Months
measure: Incidence of study-related Adverse Events
timeFrame: Length of study finish - 6 Months
measure: Complication rate as measured by Clavien-Dindo classification
timeFrame: Length of study finish - 6 Months
measure: In centres using a conventional rigid laparoscopic gamma probe: Overall ease of use of the conventional rigid laparoscopic gamma probe
timeFrame: Length of study finish - 6 Months
measure: Duration of Sentinel Lymph Node Biopsy separately for each probe used
timeFrame: Length of study finish - 6 Months
measure: Sentinel Lymph Node detection Rate
timeFrame: Length of study finish - 6 Months
measure: Number of Sentinel Lymph Nodes
timeFrame: Length of study finish - 6 Months
measure: 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.
timeFrame: Length of study finish - 6 Months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Marseille
country: France
facility: Institute Paoli-Calmettes
city: Essen
country: Germany
facility: University Hospital Essen
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
References: