BridgeMD
New treatment option for Germ Cell Tumor
Official title Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
ClinicalTrials.gov ID: NCT06133543
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99, men only
You may be able to join if
- 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...
You likely can't join if
- 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).
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Düsseldorf, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Düsseldorf, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.