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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
University Hospital of Duesseldorf
RECRUITING
Düsseldorf
Contact Information
Primary
Yue Che
yue.che@med.uni-duesseldorf.de
00492118118110
Time Frame
Start Date: 2023-09-06
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 44
Treatments
Experimental: Negative sentinel lymph node
Patients with negative sentinel lymph node biopsy are enrolled to active surveillance after surgery
Experimental: Positive sentinel lymph node
Patients with positive lymph node biopsy undergo a template retroperitoneal lymph node dissection in the same procedure
Sponsors
Leads: Heinrich-Heine University, Duesseldorf
Collaborators: Intuitive Foundation

This content was sourced from clinicaltrials.gov