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

NCT04632251 | Unknown

• 1 other identifier: LPM-012
• Study Type: interventional
• Target: 56
• Locations: 4 countries
• Sites: 4

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

• Radiation safety measurements for the staff.

  Length of study finish - 6 Months

• Duration of surgery

  Length of study finish - 6 Months

Study Arms (1)

Familiarisation

OTHER

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®

Interventions

SENSEI® DEVICE

SENSEI® laparoscopic tethered gamma probe is an intra-operative laparoscopic gamma probe system

Familiarisation

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lightpoint Medical Limited: lead

Study Sites (4)

UZ Leuven

Leuven, 3000, Belgium

NOT YET RECRUITING

Institute Paoli-Calmettes

Marseille, 13009, France

NOT YET RECRUITING

University Hospital Essen

Essen, 45147, Germany

NOT YET RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Related Publications (1)

• Abascal Junquera JM, Harke NN, Walz JC, Hadaschik B, Adshead J, Everaerts W, Goffin K, Grootendorst MR, Oldfield F, Vyas K, Fusco AM, Juanpere N, Vidal-Sicart S, Fumado L. A Drop-in Gamma Probe for Minimally Invasive Sentinel Lymph Node Dissection in Prostate Cancer: Preclinical Evaluation and Interim Results From a Multicenter Clinical Trial. Clin Nucl Med. 2023 Mar 1;48(3):213-220. doi: 10.1097/RLU.0000000000004557. Epub 2023 Jan 14.

  PMID: 36723880 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Lluis Fumado Ciutat

CONTACT

+34 650 947 553; LFumado@parcdesalutmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: November 17, 2020
• Study Start: September 16, 2020
• Primary Completion: February 16, 2021
• Study Completion: August 1, 2021
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

BE (1); FR (1); ES (1); DE (1)