Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer

NCT06133543 | Recruiting DMC

• 1 other identifier: 2023-2328
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Germ Cell Tumor; Seminoma; Nonseminomatous Germ Cell Tumor

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (2)

• Complications

  2 years

• Retrograde ejaculation

  2 years

Study Arms (2)

Negative sentinel lymph node

EXPERIMENTAL

Patients with negative sentinel lymph node biopsy are enrolled to active surveillance after surgery

Procedure: Robot-assisted ICG-guided sentinel lymph node biopsy

Positive sentinel lymph node

EXPERIMENTAL

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

Interventions

Robot-assisted ICG-guided sentinel lymph node biopsy PROCEDURE

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.

Negative sentinel lymph node; Positive sentinel lymph node

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically confirmed unequivocal testicular tumor by palpation and sonography with or without elevation of specific tumor markers AFP and/or ß-HCG.
• 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.

You may not qualify 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.
• The patient is in a reduced general condition or has a life-threatening illness.
• The patient has a psychiatric illness.

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• Intuitive Foundation: collaborator

Study Sites (1)

University Hospital of Duesseldorf

Düsseldorf, Germany

RECRUITING

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal; Seminoma; Nonseminomatous germ cell tumor

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Germinoma

Central Study Contacts

Yue Che

CONTACT

00492118118110; yue.che@med.uni-duesseldorf.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: September 6, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-03

Locations

DE (1)