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

RecruitingNAAges 18 Years - 99 YearsMaleHeinrich-Heine University, Duesseldorf
NCT06133543 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 tox

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📋 Eligibility rules (as published)
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.
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What it tests

  • Robot-assisted ICG-guided sentinel lymph node biopsy
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Where

1 site
University Hospital of Duesseldorf
Düsseldorf, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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