Clinical trial · Interventional
Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SENSEI® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Familiarisation
- description
- 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.
- interventionNames
- Device: SENSEI®
Primary outcomes (1)
- 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 (14)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDEveraerts W, Walz J, Abascal Junquera JM, Goffin K, Grootendorst MR, van 't Klooster K, Juanpere N, Valhondo-Rama R, Vidal-Sicart S, Fumado L. A Multicentre Clinical Trial Evaluating a Drop-in Gamma Probe for Minimally Invasive Sentinel Lymph Node Dissection in Prostate Cancer. Eur Urol Focus. 2024 Jan;10(1):32-40. doi: 10.1016/j.euf.2023.07.001. Epub 2023 Jul 24. PMID 37495459
- DERIVEDAbascal 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