NCT06133543 Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
| NCT ID | NCT06133543 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heinrich-Heine University, Duesseldorf |
| Condition | Germ Cell Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2023-09-06 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2023-09-06 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06133543 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 99 Years, studying Germ Cell Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06133543 currently recruiting?
Yes, NCT06133543 is actively recruiting participants. Contact the research team at yue.che@med.uni-duesseldorf.de for enrollment information.
Where is the NCT06133543 trial being conducted?
This trial is being conducted at Düsseldorf, Germany.
Who is sponsoring the NCT06133543 clinical trial?
NCT06133543 is sponsored by Heinrich-Heine University, Duesseldorf. The trial plans to enroll 44 participants.