Status:
RECRUITING
Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Collaborating Sponsors:
Intuitive Foundation
Conditions:
Germ Cell Tumor
Seminoma
Eligibility:
MALE
18-99 years
Phase:
NA
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...
Detailed Description
The sentinel lymph node biopsy in testicular cancer is a novel technique that has not been extensively studied. This technique shows promise and could potentially become the future standard in the pri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06133543
Start Date
September 6 2023
End Date
March 31 2028
Last Update
September 15 2025
Active Locations (1)
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1
University Hospital of Duesseldorf
Düsseldorf, Germany