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

NCT06133543 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-09-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Intuitive Foundation

    collaborator UNKNOWN

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-06
Primary Completion
2026-03-31
Completion
2028-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06133543 on ClinicalTrials.gov