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

Study acronym: RAISN
StatusRecruiting
PhaseNot applicable
Started2023-09-06
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 15, 2025 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-09-09
minor
Study Status, Oversight, Study Design v1
Primary completion date2024-10-31→2026-03-31
Completion date2026-10-31→2028-03-31
Enrollment target27→44
2023-11-10
minor
Original filing
Robot-assisted image-guided sentinel lymph node biopsy (RAISN) in testicular cancer is a novel technique that has not been widely investigated yet. This technique is promising and could be implemented as a future standard in the primary diagnostic work up of clinical stage (CS) I testicular cancer. Current staging strategies have a poor predictive accuracy for occult metastatic disease. So far, feasibility studies used 99mTC-nanocolloid staining and laparoscopy and all patients with tumor-positive nodes received adjuvant systemic treatment. The development of a robot-assisted image-guided lymph node resection technique with indocyanine green (ICG) is potentially more precise, easier to apply and widely available. With this new diagnostic approach the management of newly diagnosed testicular cancer patients might be changed dramatically by reducing overtreatment and treatment-related toxicity with a minimally invasive robot-assisted procedure.
Trial Details
NCT Number NCT06133543
Lead Sponsor Heinrich-Heine University, Duesseldorf
Collaborators: Intuitive Foundation
Conditions Germ Cell Tumor, Seminoma, Nonseminomatous Germ Cell Tumor
Enrollment 44 participants
Start Date 2023-09-06
Primary Completion 2026-03-31 (estimated)
Study Completion 2028-03-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-15