Robot-assisted biopsy for testicular cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates a novel technique called robot-assisted image-guided sentinel lymph node biopsy (RAISN) for patients with testicular cancer. The approach aims to improve the accuracy of diagnosing occult metastatic disease in clinical stage I testicular cancer, potentially reducing unnecessary treatments and associated toxicities. By utilizing indocyanine green (ICG) for imaging, this minimally invasive procedure could change the management of newly diagnosed patients. The study will assess the feasibility and effectiveness of this technique compared to traditional methods.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospital of Duesseldorf
  Düsseldorf, Germany Recruiting

Study contacts

• Study coordinator: Yue Che
• Email: yue.che@med.uni-duesseldorf.de
• Phone: 00492118118110

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.