Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
MALE
NCT06133543

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

Led by Heinrich-Heine University, Duesseldorf · Updated on 2025-09-15

44

Participants Needed

1

Research Sites

238 weeks

Total Duration

On this page

Sponsors

H

Heinrich-Heine University, Duesseldorf

Lead Sponsor

I

Intuitive Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 99Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinically confirmed testicular tumor by palpation and ultrasound, with or without elevated tumor markers AFP and/or ß-HCG
  • No evidence of metastases on contrast-enhanced CT scan of chest and abdomen
  • Patient is at least 18 years old
  • Patient can communicate effectively and understands the study information to give informed consent
Not Eligible

You will not qualify if you...

  • Testicular tumor with uncertain diagnosis
  • Small testicular masses less than 1 cm
  • Previous scrotal or retroperitoneal surgery unrelated to germ cell tumor
  • Prior chemotherapy
  • Prior retroperitoneal radiotherapy
  • History of allergic reaction to indocyanine green or iodine
  • Poor general health or life-threatening illness
  • Psychiatric illness

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital of Duesseldorf

Düsseldorf, Germany

Actively Recruiting

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Research Team

Y

Yue Che

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

2

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