Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-99
SponsorHeinrich-Heine University, Duesseldorf
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Robot-assisted ICG-guided sentinel lymph node biopsy
Treatment groups
44 Participants
are divided into 2 treatment groupsSponsors and collaborators
Heinrich-Heine University, Duesseldorf
Lead sponsor
Intuitive Foundation
Collaborator
Source ClinicalTrials.gov