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

Starting soon · Not applicable

Conditions studied: Testicular Cancer, Testicular Germ Cell Tumor

In brief

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.

Key facts

Study ID

NCT07699640

Run by

Heinrich-Heine University, Duesseldorf

People needed

171

Starts

2027-01-01

Expected to finish

2031-01-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male participants aged 18 years or older.
• Clinically suspected testicular germ cell tumor based on physical examination and scrotal ultrasonography, with or without elevated serum tumor markers (AFP and/or β-hCG).
• No radiological evidence of metastatic disease on preoperative contrast-enhanced computed tomography (CT) of the chest and abdomen (clinical stage I).
• Eligible for radical inguinal orchiectomy.
• Able to understand the study procedures and provide written informed consent.
• Willing and able to comply with the study protocol and follow-up schedule.

You may not qualify if…

• Previous scrotal or retroperitoneal surgery unrelated to germ cell tumor treatment, except surgery for cryptorchidism during childhood.
• Previous malignancy requiring abdominal surgery, chemotherapy, or radiotherapy that could interfere with study participation.
• Previous radiotherapy involving the retroperitoneum.
• Known hypersensitivity to indocyanine green (ICG), iodine, or sodium iodide.
• Severe medical condition that precludes surgery or study participation.
• Psychiatric disorder or other condition preventing compliance with study procedures.
• Inability to understand the German language sufficiently to provide informed consent and complete study assessments.
• Individuals under legal guardianship or otherwise unable to provide legally valid informed consent.

Where it is running

• Helsinki University Hospital — Helsinki, Finland
• University of Turku — Turku, Finland
• University Hospital Ulm — Ulm, Baden-Wurttemberg, Germany
• University Hospital Würzburg — Würzburg, Bavaria, Germany
• Asklepios Klinik Altona — Hamburg, Free and Hanseatic City of Hamburg, Germany
• University Hospital Marbug — Marburg, Hesse, Germany
• University Hospital Cologne — Cologne, North Rhine-Westphalia, Germany
• University Hospital Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany
• Helios University Hospital Wuppertal — Wuppertal, North Rhine-Westphalia, Germany
• University Hospital Dresden — Dresden, Saxony, Germany

Full record on ClinicalTrials.gov

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