A Multicentre Clinical Trial Evaluating a Drop-in Gamma Probe for Minimally Invasive Sentinel Lymph Node Dissection...

Area of Science:

• Urology
• Surgical Oncology
• Nuclear Medicine

Background:

• Prostate cancer (PCa) management often involves sentinel lymph node biopsy (SeLNB) to assess nodal metastasis.
• Accurate detection of sentinel lymph nodes (SeLNs) is crucial for staging and treatment planning in PCa.
• Existing methods for SeLN detection may have limitations in maneuverability and detection efficacy.

Purpose of the Study:

• To evaluate the safety and performance of a novel drop-in gamma probe for SeLNB in prostate cancer patients.
• To determine the SeLN detection rate using the drop-in gamma probe system.
• To compare the efficacy and safety of the drop-in probe against conventional methods.

Main Methods:

• A prospective, open-label, multicentre clinical trial involving 27 PCa patients undergoing minimally invasive surgery.
• Patients received [99mTc]Tc-nanocolloid injection followed by lymphoscintigraphy.
• Sentinel lymph nodes were identified using the drop-in gamma probe and a rigid laparoscopic gamma probe (RLGP).

Main Results:

• The drop-in gamma probe achieved a 100% SeLN detection rate (95% CI 87.2-100%), identifying 85 SeLNs across 27 patients.
• The device detected two SeLNs missed by the RLGP due to maneuverability limitations.
• No adverse events or complications were associated with the drop-in probe's use.

Conclusions:

• The drop-in gamma probe is a safe and effective tool for SeLNB in prostate cancer.
• The device offers superior maneuverability and enhanced SeLN detection compared to the conventional RLGP.
• This technology meets the performance and safety requirements for clinical SeLNB in PCa.