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Minimally-invasive ICG-guided Retroperitoneal Sentinel Lymph Node Dissection in the Primary Staging of Testicular Cancer Versus Standard of Care

NCT07699640 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2026-07-13

No results posted yet for this study

Summary

Testicular cancer is highly curable, but approximately 20-30% of patients with clinical stage I disease harbor occult retroperitoneal lymph node metastases that are not detected by conventional imaging. Current risk-adapted management may lead to overtreatment in some patients while failing to identify others who are at increased risk of relapse.

The RAISN 2 study evaluates whether minimally invasive indocyanine green (ICG)-guided retroperitoneal sentinel lymph node dissection can improve primary staging and risk stratification in patients with clinical stage I testicular cancer. Participants will be randomized in a 5:1 ratio to undergo either orchiectomy combined with ICG-guided sentinel lymph node dissection or standard orchiectomy followed by guideline-based surveillance.

All participants will undergo structured follow-up according to current clinical guidelines. The primary objective is to estimate the 2-year relapse-free survival of patients undergoing the sentinel lymph node approach. Secondary objectives include assessment of overall survival, relapse patterns, perioperative morbidity, quality of life, psychological outcomes, and the feasibility and safety of the procedure.

This multicenter study aims to determine whether sentinel lymph node-guided staging provides more accurate risk stratification while avoiding unnecessary treatment and maintaining oncological safety.

Conditions

  • Testicular Cancer
  • Testicular Germ Cell Tumor

Interventions

PROCEDURE

ICG-Guided Retroperitoneal Sentinel Lymph Node Biopsy

Minimally invasive laparoscopic or robot-assisted retroperitoneal sentinel lymph node biopsy performed after intratesticular injection of indocyanine green (ICG) using near-infrared fluorescence imaging for sentinel lymph node identification.

PROCEDURE

Radical Inguinal Orchiectomy

Standard radical inguinal orchiectomy performed according to current clinical guidelines.

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Peter Albers · Department of Urology, University Hospital of Heinrich Heine University, Düsseldorf

  • Yue Che · University Hospital of Cologne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2029-01-31
Completion
2031-01-31

Countries

  • Finland
  • 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 NCT07699640 on ClinicalTrials.gov