RAISN Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer

What this Trial Is About

Researchers are evaluating a novel technique called robot-assisted image-guided sentinel lymph node biopsy for diagnosing clinical stage I testicular cancer. This method aims to improve the accuracy of detecting metastatic disease, which current staging strategies struggle with. The study focuses on reducing overtreatment and treatment-related toxicity by using a minimally invasive approach with indocyanine green (ICG) fluorescence guidance, which may be more precise and easier to apply than previous methods using technetium and laparoscopy. The procedure involves injecting ICG into the testicular tissue at the start of surgery, followed by robotic-assisted removal of sentinel lymph nodes guided by fluorescence imaging. If the biopsy shows no tumor, patients enter active surveillance. If tumor-positive nodes are found, a retroperitoneal lymph node dissection is performed during the same procedure. No adjuvant systemic treatment is given after surgery. The follow-up period for participants lasts two years. During the study, participants undergo assessments including immediate biopsy analysis of lymph nodes, imaging with contrast-enhanced CT scans for staging, and monitoring for complications such as retrograde ejaculation over two years. Researchers will measure the sensitivity of this biopsy technique as the primary outcome, alongside safety outcomes. Participants will be closely observed to evaluate the precision and impact of this new diagnostic tool in managing testicular cancer.

Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer