This study evaluated the safety and performance of a drop-in gamma probe for prostate cancer (PCa) sentinel lymph node biopsy (SeLNB) in a prospective, open-label, multicentre, single-arm clinical trial.
The main objective was to determine the sentinel lymph node (SeLN) detection rate with the drop-in gamma probe system. The secondary objectives were overall performance and safety.
At three European centres, patients received an ultrasound-guided systemic and tumour-targeted injection of [99mTc]Tc-nanocolloid followed by planar lymphoscintigraphy and/or single-photon emission computerised tomography. The next day, manual laparoscopic or robot-assisted radical prostatectomy was performed, including SeLN dissection (SeLND) and extended pelvic lymph node dissection (ePLND).
SeLNs were detected with the drop-in probe and a rigid laparoscopic gamma probe (RLGP). The primary endpoint of the study was the SeLND rate defined as the percentage of patients with at least one SeLN detected in vivo by the drop-in probe. The secondary endpoints included diagnostic performance, ease of SeLN detection, number of SeLNs detected, and safety. The first two patients at each site (six in total) were used for familiarisation.
A total of 27 patients were included in the main analysis. SENSEI successfully detected at least one SeLN in all 27 patients, resulting in a detection rate of 100% (95% confidence interval 87.2-100%). The total number of SeLNs identified with SENSEI was 85 (median three SeLNs per patient, range 1-6); of these 85 SeLNs, 12 were located outside of the ePLND template. In the nine patients in whom the RLGP was used, SENSEI detected two SeLNs that could not be detected with the RLGP due to manoeuvrability restrictions. Ten of the 27 patients were pN1; four patients had a false-negative SeLNB. No adverse events or complications were related to the use of the drop-in probe.
The study demonstrated that the drop-in gamma probe meets the performance and safety requirements for SeLNB in PCa. The device provided improved manoeuvrability and SeLN detection compared with the conventional RLGP.
A novel device was tested for detecting sentinel lymph nodes during minimally invasive surgery for prostate cancer. In this first evaluation, the performance and safety of the device were evaluated positively.
European urology focus. 2023 Jul 24 [Epub ahead of print]
Wouter Everaerts, Jochen Walz, Jose M Abascal Junquera, Karolien Goffin, Maarten R Grootendorst, Klaas van 't Klooster, Nuria Juanpere, Raquel Valhondo-Rama, Sergi Vidal-Sicart, Lluis Fumado
Laboratory of Ion Channel Research, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium; Department of Urology, University Hospitals Leuven, Leuven, Belgium., Department of Urology, Institute Paoli-Calmettes Cancer Centre, Marseille, France., Department of Urology, Hospital Del Mar, Barcelona, Spain; Department of Medicine and Life Sciences, Universitat Pompeu Fabra, Barcelona, Spain., Department of Nuclear Medicine, University Hospitals Leuven and KU Leuven, Leuven, Belgium., Department of Clinical Operations, Lightpoint Medical Ltd., Amsterdam, The Netherlands., Department of Pathology, Hospital Del Mar, Barcelona, Spain., Department of Nuclear Medicine, Hospital Del Mar, Barcelona, Spain., Department of Urology, Hospital Del Mar, Barcelona, Spain; Department of Medicine and Life Sciences, Universitat Pompeu Fabra, Barcelona, Spain. Electronic address: .