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

Recruiting now · Not applicable

Conditions studied: Germ Cell Tumor, Seminoma, Nonseminomatous Germ Cell Tumor

In brief

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.

Key facts

Study ID

NCT06133543

Run by

Heinrich-Heine University, Duesseldorf

People needed

44

Starts

2023-09-06

Expected to finish

2028-03-31

Last updated by the study team

2025-09-15

Who can join

Age: 18 and older, up to 99. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University Hospital of Duesseldorf — Düsseldorf, Germany (enrolling)

Full record on ClinicalTrials.gov

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