Actively Recruiting
Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
Led by Heinrich-Heine University, Duesseldorf · Updated on 2025-09-15
44
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
Sponsors
H
Heinrich-Heine University, Duesseldorf
Lead Sponsor
I
Intuitive Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically confirmed testicular tumor by palpation and ultrasound, with or without elevated tumor markers AFP and/or ß-HCG
- No evidence of metastases on contrast-enhanced CT scan of chest and abdomen
- Patient is at least 18 years old
- Patient can communicate effectively and understands the study information to give informed consent
You will not qualify if you...
- Testicular tumor with uncertain diagnosis
- Small testicular masses less than 1 cm
- Previous scrotal or retroperitoneal surgery unrelated to germ cell tumor
- Prior chemotherapy
- Prior retroperitoneal radiotherapy
- History of allergic reaction to indocyanine green or iodine
- Poor general health or life-threatening illness
- Psychiatric illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital of Duesseldorf
Düsseldorf, Germany
Actively Recruiting
Research Team
Y
Yue Che
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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