Robot-assisted biopsy for testicular cancer
RAISN - Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
This study is testing a new robot-assisted method for taking biopsies in men with testicular cancer to see if it can more accurately find hidden cancer and reduce unnecessary treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Male |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Düsseldorf) |
| Trial ID | NCT06133543 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a novel technique called robot-assisted image-guided sentinel lymph node biopsy (RAISN) for patients with testicular cancer. The approach aims to improve the accuracy of diagnosing occult metastatic disease in clinical stage I testicular cancer, potentially reducing unnecessary treatments and associated toxicities. By utilizing indocyanine green (ICG) for imaging, this minimally invasive procedure could change the management of newly diagnosed patients. The study will assess the feasibility and effectiveness of this technique compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are adults with clinically confirmed testicular tumors and no evidence of metastases.
Not a fit: Patients with uncertain tumor dignity or those who have undergone prior surgeries for reasons other than germ cell tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could lead to more accurate diagnoses and reduced overtreatment for testicular cancer patients.
How similar studies have performed: While few studies have explored sentinel lymph node diagnostics in testicular cancer, the use of similar robotic and imaging techniques has shown promise in other cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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.
Where this trial is running
Düsseldorf
- University Hospital of Duesseldorf — Düsseldorf, Germany (Recruiting)
Study contacts
- Study coordinator: Yue Che
- Email: yue.che@med.uni-duesseldorf.de
- Phone: 00492118118110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.