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Studies

Interventional Not yet recruiting

NCT07699640 on ClinicalTrials.gov

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

Official title: RAISN 2: Prospective Randomized Trial of Minimally-invasive ICG-guided Retroperitoneal Sentinel Lymph Node Dissection in the Primary Staging of Testicular Cancer Versus Standard of Care

  • Sponsor: Heinrich Heine University Düsseldorf
  • Enrollment: 171 (Estimated)
  • Study start: 2027-01-01 (Estimated)
  • Primary completion: 2029-01-01 (Estimated)
  • Study completion: 2031-01-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Participants are randomized in a 5:1 ratio to receive either minimally invasive ICG-guided retroperitoneal sentinel lymph node biopsy combined with inguinal orchiectomy or standard inguinal orchiectomy followed by guideline-based surveillance. The unequal allocation was selected to maximize prospective evaluation of the investigational staging procedure while maintaining a concurrent control group.
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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

Intervention / Treatment

  • Procedure: ICG-Guided Retroperitoneal Sentinel Lymph Node Biopsy
  • Procedure: Radical Inguinal Orchiectomy

Primary Outcome Measures

  • 2-Year Relapse-Free Survival (RFS) (24 months after randomization)
    Relapse-free survival is defined as the time from randomization to the first occurrence of radiologically or histopathologically confirmed disease recurrence, serological progression according to guideline-based clinical assessment, clinically unequivocal progression requiring salvage therapy, or death from any cause, whichever occurs first.

Countries

Finland, Germany

Locations and Investigators

  • Helsinki University Hospital, Helsinki, Finland
  • University of Turku, Turku, Finland
    • Peter Boström
  • University Hospital Ulm, Ulm, Germany
    • Friedemann Zengerling
  • University Hospital Würzburg, Würzburg, Germany
    • Charis Kalogirou
  • Asklepios Klinik Altona, Hamburg, Germany
    • Christian Wülfing
  • University Hospital Marbug, Marburg, Germany
    • Julia Heinzelbecker
  • University Hospital Cologne, Cologne, Germany
    • Axel Heidenreich
  • University Hospital Düsseldorf, Düsseldorf, Germany
    • Peter Albers
    • Marieke Vermeulen
    • Peter Albers (Principal Investigator)
  • Helios University Hospital Wuppertal, Wuppertal, Germany
    • Friedrich von Rundstedt
  • University Hospital Dresden, Dresden, Germany
    • Christian Thomas

Study Officials

  • Peter Albers (Principal Investigator) — Department of Urology, University Hospital of Heinrich Heine University, Düsseldorf
  • Yue Che (Principal Investigator) — University Hospital of Cologne