An interventional study of Robot-assisted ICG-guided sentinel lymph node biopsy in Germ Cell Tumor, Seminoma and Nonseminomatous Germ Cell Tumor, sponsored by Heinrich-Heine University, Duesseldorf. Recruiting at 1 site in Germany. Open to male participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Heinrich-Heine University, Duesseldorf · Not applicable, Interventional, and Treatment
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.
The sentinel lymph node biopsy in testicular cancer is a novel technique that has not been extensively studied. This technique shows promise and could potentially become the future standard in the primary diagnosis of testicular cancer in clinical stage I.
In cases of clinical stage I testicular cancer, 20% to 30% of patients experience a recurrence. Strategies such as adjuvant chemotherapy or retroperitoneal lymph node dissection can reduce the risk of recurrence to 2% and 9%, respectively. However, the issue with these strategies is that the majority of patients may receive unnecessary treatment and endure the toxicity of chemotherapy or surgery. German and European guidelines recommend a risk-adapted approach. Testicular tumor patients with specific histopathological features are classified into low and high risk, with adjuvant therapy recommended accordingly. This strategy allows for more targeted treatment but still maintains a limited sensitivity of approximately 73%.
There have been few studies investigating the possibility of sentinel lymph node diagnostics in testicular cancer. Reasons for this include the rarity of the disease coupled with a lack of experience in minimally invasive surgery for testicular cancer treatment. Previous sentinel lymph node studies utilized the radioligand technique with technetium, which was limited to centers with a nuclear medicine department. With the advancing development of robotics and fluorescence technology using indocyanine green, there is an opportunity for a novel, minimally invasive lymph node diagnostic method applicable on a broader scale for testicular cancer patients.
In previous feasibility studies on sentinel lymph node diagnostics in testicular tumor patients, the use of 99mTC-nanocolloid staining and laparoscopy achieved a 90% sensitivity. The development of a robot-assisted image-guided lymph node resection technique using indocyanine green (ICG) is potentially more precise, easier to apply, and generally more available. Multiple studies in other tumor entities have demonstrated the non-inferiority and superiority of ICG over technetium. This new diagnostic approach could drastically change the treatment for newly diagnosed testicular cancer patients by reducing overtreatment and treatment-related toxicity through a minimally invasive robot-assisted procedure.
63 studies on the registry are indexed under Seminoma; 15 are open to participants now.
This study's planned enrollment of 44 is below the median of 50 across 47 interventional studies indexed under Seminoma.
Browse Seminoma studies →Heinrich-Heine University, Duesseldorf is the lead sponsor of 180 studies on the registry; 54 are open to participants now.
Compared within Seminoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms, Germ Cell and Embryonal. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with negative sentinel lymph node biopsy are enrolled to active surveillance after surgery
Procedure: Robot-assisted ICG-guided sentinel lymph node biopsy
Patients with positive lymph node biopsy undergo a template retroperitoneal lymph node dissection in the same procedure
Procedure: Robot-assisted ICG-guided sentinel lymph node biopsy
The robot-assisted ICG-guided sentinel node (SN) biopsy is conducted as follows: At the start of the operation, indocyanine green (ICG) solution is transscrotally injected into the testicular parenchyma. The patient is positioned in the nephrectomy posture. After port placement and docking of the robotic system, the sentinel node(s) should be visible with the fluorescence camera. The SN is removed and sent for immediate frozen section biopsy evaluation. The inguinal orchiectomy is performed subsequently until the biopsy results are available. If the biopsy is negative, the procedure concludes. If the biopsy shows viable tumor, indicating clinical stage IIA and the indication for systematic unilateral retroperitoneal lymph node dissection. The patient was informed about the potential expansion of the procedure upon study enrollment. After the procedure, all patients are placed under observation and do not receive adjuvant systemic treatment. The follow-up period extends to 2 years.
Sensitivity
The primary endpoint of the study is to demonstrate that RAISN has a sensitivity of ≥ 90% in nodal staging for testicular tumors in clinical stage I.
Time frame: 2 years
Complications
EAUiaiC-classification and Clavien Dindo
Time frame: 2 years
Retrograde ejaculation
Time frame: 2 years
Plan to share: Undecided
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