Clinical trial · Interventional
Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
RAISN - Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Germ Cell Tumor | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Nonseminomatous Germ Cell Tumor | — | UNRESOLVED | — |
| Seminoma | Seminoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robot-assisted ICG-guided sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Negative sentinel lymph node
- description
- Patients with negative sentinel lymph node biopsy are enrolled to active surveillance after surgery
- interventionNames
- Procedure: Robot-assisted ICG-guided sentinel lymph node biopsy
- type
- EXPERIMENTAL
- label
- Positive sentinel lymph node
- description
- Patients with positive lymph node biopsy undergo a template retroperitoneal lymph node dissection in the same procedure
- interventionNames
- Procedure: Robot-assisted ICG-guided sentinel lymph node biopsy
Primary outcomes (1)
- measure
- Sensitivity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Clinically confirmed unequivocal testicular tumor by palpation and sonography with or without elevation of specific tumor markers AFP and/or ß-HCG. * Clinical exclusion of metastases in preoperative staging using contrast-enhanced CT of the thorax and abdomen. * The patient is of legal age. * The patient can communicate with the investigator without issues or limitations and can understand and sign the patient information and consent form without problems or limitations. Exclusion Criteria: * Testicular tumor with uncertain dignity * Patients with small testicular masses (\< 1 cm) * Patients with prior scrotal or retroperitoneal surgery for reasons other than a germ cell tumor. * The patient has received different chemotherapy. * The patient has undergone retroperitoneal radiotherapy. * Exclusion criteria for the use of ICG include a history of anaphylactic reactions to ICG and iodine intolerance (ICG solution contains sodium iodide). * The patient is in a reduced general condition or has a life-threatening illness. * The patient has a psychiatric illness.
References
Publications (0)
Data not yet available