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Multicenter Study
. 2023 Mar 1;48(3):213-220.
doi: 10.1097/RLU.0000000000004557. Epub 2023 Jan 14.

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

Jose M Abascal Junquera  1 , Nina N Harke  2 , Jochen C Walz  3 , Boris Hadaschik  4 , Jim Adshead  5 , Wouter Everaerts  6 , Karolien Goffin  7 , Maarten R Grootendorst  8 , Francesca Oldfield  9 , Kunal Vyas  9 , Antoni Mestre Fusco  10 , Nuria Juanpere  11 , Sergi Vidal-Sicart  12 , Lluis Fumado  1
Affiliations
Multicenter Study

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

Jose M Abascal Junquera et al. Clin Nucl Med. .

Abstract

Purpose: This study evaluated the performance of a drop-in gamma probe for prostate cancer (PCa) sentinel lymph node dissection (SLND) in a pelvic phantom, porcine model, and in PCa patients as part of an ongoing prospective multicenter clinical trial.

Methods: Two design variants of the drop-in gamma probe (SENSEI; Lightpoint Medical Ltd) were assessed in the pelvic phantom, and the preferred design was evaluated in a porcine model with clinically representative volumes and 99mTc activities. In the clinical trial, radical prostatectomy, SLND, and extended pelvic lymph node dissection were performed the day after 99mTc-nanocolloid injection and imaging. Sentinel lymph nodes (SLNs) were detected with the drop-in probe and a rigid laparoscopic gamma probe (RLGP). An interim analysis was performed after 10 patients were recruited.

Results: The narrow field of view probe design outperformed the wide field of view design in the pelvic phantom (detection rate, 100% vs 50%). In the porcine model, all activity concentrations could be successfully detected. The drop-in gamma probe successfully detected SLNs in all 10 patients (detection rate, 100%). Two of the SLNs identified by the drop-in gamma probe could not be found with the RLGP. No false-negative cases and no adverse events related to the SLND procedure or the drop-in gamma probe occurred.

Conclusion: The drop-in gamma probe meets the usability and performance requirements for SLND in PCa and provides performance advantages over the RLGP. The final clinical study results will confirm the performance of the technique across multiple sites.

Trial registration: ClinicalTrials.gov NCT04632251.

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Conflict of interest statement

Conflicts of interest and sources of funding: This research was supported by funding from Innovate UK (grants 105293 and 102840). Lightpoint Medical Ltd (Chesham, United Kingdom) provided material support in the form of the SENSEI drop-in gamma probe system. M.R.G., F.O., and K.V. are employees of and have equity in Lightpoint Medical Ltd. B.H. has had advisory roles for ABX, AAA/Novartis, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Janssen R&D, Lightpoint Medical Ltd, and Pfizer; has received research funding from Astellas, Bristol Myers Squibb, AAA/Novartis, German Research Foundation, Janssen R&D, and Pfizer; and has received compensation for travel from Astellas, AstraZeneca, Bayer and Janssen R&D. N.N.H. reports personal fees from Intuitive Surgical, Lightpoint Medical Ltd, Pfizer, and Janssen. W.E. has received research funding from Ipsen and fees from Lightpoint Medical Ltd and Janssen (to the institution, KU Leuven). The other authors have none declared.

References

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