Robot-assisted lymph node sampling with a green dye in testicular cancer
Tests a robot-assisted dye-guided lymph node biopsy in people with testicular cancer.
Key facts
- Who runs it
- Heinrich-Heine University, Duesseldorf
- Where
- Germany1 site in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
- Status
- Recruiting
- People taking part
- 44 people, planned
- Started
- 6 Sept 2023
- Expected to end
- 31 Mar 2028
- Type of study
- Interventional, 2 groups
- Treatments tested
- Robot-assisted ICG-guided sentinel lymph node biopsy
- Record updated
- 15 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adult men with a newly found testicular tumor that has not spread. They will have a robot-assisted procedure that uses the dye ICG to find and remove the first lymph nodes the cancer would reach.
- Age
- 18 Years to 99 Years; you must be of legal age.
- Sex
- Men only.
- Disease stage
- A clear testicular tumor found by touch and ultrasound. A contrast CT scan of the chest and belly must show no spread (clinical stage I).
- Earlier treatment
- You cannot join if you had other chemotherapy, radiotherapy to the back of the belly, or surgery on the scrotum or back of the belly for reasons other than a germ cell tumor.
- Biomarker or test result
- Tumor markers AFP and/or ß-HCG may be raised or normal.
Main reasons for not taking part
- A testicular tumor whose nature (harmless or cancer) is unclear, or a mass smaller than 1 cm (0.4 in)
- Earlier scrotal or retroperitoneal surgery for reasons other than a germ cell tumor
- Other chemotherapy before, or retroperitoneal radiotherapy
- Severe allergic reaction to ICG, or intolerance to iodine
- Poor general health, a life-threatening illness, or a psychiatric illness
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- The patient is in a reduced general condition or has a life-threatening illness
- The patient has a psychiatric illness
- Exclusion criteria for the use of ICG include a history of anaphylactic reactions to ICG and iodine intolerance (ICG solution contains sodium iodide)
- Testicular tumor with uncertain dignity
- Patients with small testicular masses (< 1 cm)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Negative sentinel lymph nodeTreatment being tested
Patients with negative sentinel lymph node biopsy are enrolled to active surveillance after surgery
Treatment: Robot-assisted ICG-guided sentinel lymph node biopsy
- Positive sentinel lymph nodeTreatment being tested
Patients with positive lymph node biopsy undergo a template retroperitoneal lymph node dissection in the same procedure
Treatment: Robot-assisted ICG-guided sentinel lymph node biopsy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- RAISN - Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
- Plain-language title
- Robot-assisted lymph node sampling with a green dye in testicular cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Fit questions
- Built from NCT06133543, who can take part
- Record updated
- 15 September 2025