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Not recruiting yet

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

NCT07699640 · Heinrich-Heine University, Duesseldorf · Updated 13 July 2026

What is being tested
ICG-Guided Retroperitoneal Sentinel Lymph Node Biopsy; Radical Inguinal Orchiectomy
For
Testicular Cancer; Testicular Germ Cell Tumor
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 171 people. The full rules are on the registry page.
Where
Finland, Germany (10 sites)
When
Starts or started Jan 2027, ends Jan 2031. Registered 13 July 2026.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT07699640

Sites

  • Helsinki University HospitalHelsinki, Finland
  • University of TurkuTurku, Finland
  • University Hospital UlmUlm, Baden-Wurttemberg, Germany
  • University Hospital WürzburgWürzburg, Bavaria, Germany
  • Asklepios Klinik AltonaHamburg, Free and Hanseatic City of Hamburg, Germany
  • University Hospital MarbugMarburg, Hesse, Germany
  • University Hospital CologneCologne, North Rhine-Westphalia, Germany
  • University Hospital DüsseldorfDüsseldorf, North Rhine-Westphalia, Germany
  • Helios University Hospital WuppertalWuppertal, North Rhine-Westphalia, Germany
  • University Hospital DresdenDresden, Saxony, Germany