Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer (LPM-012)

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

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: SENSEI®

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Not yet recruiting
    • UZ Leuven
    • Contact: Wouter Evearaets; Phone Number: +3216346930; Email: wouter.everaerts@uzleuven.be
    • Principal Investigator: Wouter Evearaets
• France
  • Marseille, France, 13009
    • Not yet recruiting
    • Institute Paoli-Calmettes
    • Contact: Jochen Walz; Phone Number: +33 491 223532; Email: WALZJ@ipc.unicancer.fr
    • Principal Investigator: Jochen WALZ
• Germany
  • Essen, Germany, 45147
    • Not yet recruiting
    • University Hospital Essen
    • Contact: Boris Hadaschik; Phone Number: +492017233210; Email: Boris.HadaschikC@.uk-essen.de
    • Principal Investigator: Boris Hadaschik
• Spain
  • Barcelona, Spain, 08003
    • Recruiting
    • Hospital del Mar
    • Contact: Lluis Fumado Ciutat; Phone Number: +34 650 947 553; Email: LFumado@parcdesalutmar.cat
    • Principal Investigator: Lluis Fumado Ciutat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Familiarisation; 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®; SENSEI® laparoscopic tethered gamma probe is an intra-operative laparoscopic gamma probe system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Lightpoint Medical Limited

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Anticipated): February 16, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 11, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: LPM-012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No