Minimally-invasive ICG-guided Retroperitoneal Sentinel Lymph Node Dissection in the Primary Staging of Testicular Cancer Versus Standard of Care (RAISN 2)

July 8, 2026 updated by: Heinrich-Heine University, Duesseldorf

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Testicular germ cell tumors are the most common solid malignancy in young adult men and are associated with excellent long-term survival when managed appropriately. In patients with clinical stage I disease, approximately 20-30% harbor occult retroperitoneal lymph node metastases despite the absence of radiologically detectable disease. Current management strategies rely on histopathological risk factors to guide surveillance or adjuvant treatment; however, these factors have limited predictive accuracy and may result in both overtreatment and undertreatment.

Sentinel lymph node (SLN) mapping has been successfully established in several solid malignancies as a minimally invasive method for detecting occult lymphatic metastases. The RAISN feasibility study demonstrated that minimally invasive indocyanine green (ICG)-guided retroperitoneal sentinel lymph node dissection is technically feasible in patients with clinical stage I testicular cancer, achieving a 100% sentinel lymph node detection rate without increasing perioperative morbidity. These findings provide the basis for prospective validation in a larger patient population.

RAISN 2 is a prospective, randomized, multicenter clinical trial designed to evaluate whether ICG-guided retroperitoneal sentinel lymph node dissection improves primary staging and risk stratification in patients with clinical stage I testicular cancer. Eligible participants will be randomized in a 5:1 ratio to receive either minimally invasive ICG-guided sentinel lymph node dissection combined with inguinal orchiectomy (intervention arm) or inguinal orchiectomy followed by guideline-based surveillance (control arm). The unequal allocation was chosen to maximize the prospective evaluation of the novel staging procedure while maintaining a concurrent reference group.

In the intervention arm, indocyanine green is injected into the affected testis immediately before minimally invasive retroperitoneal exploration. Near-infrared fluorescence imaging is used to identify and remove sentinel lymph nodes for histopathological evaluation. After surgery, patients in both study arms undergo guideline-based surveillance without routine adjuvant treatment. In the event of disease recurrence, salvage therapy is administered according to current national and international guidelines.

The primary objective of the study is to estimate the 2-year relapse-free survival of patients undergoing the sentinel lymph node strategy. Secondary objectives include evaluation of overall survival, relapse patterns, time to relapse, perioperative morbidity, postoperative complications, quality of life, psychological outcomes, technical feasibility, and safety of the procedure. In addition, translational analyses using prospectively collected blood and tissue samples will explore clinicopathological and molecular factors associated with oncological outcomes.

The results of this study are expected to determine whether minimally invasive ICG-guided sentinel lymph node dissection can provide more accurate nodal staging, reduce unnecessary treatment, and maintain oncological safety in patients with clinical stage I testicular cancer.

Study Type

Interventional

Enrollment (Estimated)

171

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
      • Helsinki, Finland, 00014
        • Helsinki University Hospital
      • Turku, Finland, 20520
  • Germany
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89081
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • University Hospital Würzburg
        • Contact:
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 22763
    • Hesse
      • Marburg, Hesse, Germany, 35043
    • North Rhine-Westphalia
    • Saxony
      • Dresden, Saxony, Germany, 01307

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICG-Guided Sentinel Lymph Node Biopsy plus Orchiectomy
Participants undergo minimally invasive ICG-guided retroperitoneal sentinel lymph node biopsy followed by radical inguinal orchiectomy. After surgery, patients undergo guideline-based surveillance without routine adjuvant therapy.
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.
Active Comparator: Standard Orchiectomy and Surveillance
Participants undergo radical inguinal orchiectomy followed by guideline-based surveillance according to current clinical practice.
Procedure: Radical Inguinal Orchiectomy
Standard radical inguinal orchiectomy performed according to current clinical guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-Year Relapse-Free Survival (RFS)
Time Frame: 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.
24 months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 24 months after randomization
Overall survival is defined as the time from randomization until death from any cause.
24 months after randomization
Time to Tumor Recurrence
Time Frame: 24 months after randomization
Time from randomization to the first documented recurrence.
24 months after randomization
Rate of Salvage Therapy
Time Frame: 24 months after randomization
Proportion of participants requiring salvage treatment including chemotherapy, retroperitoneal lymph node dissection, radiotherapy, or other oncological treatment.
24 months after randomization
Perioperative Morbidity
Time Frame: up to 30 days after surgery
Perioperative complications graded according to the Clavien-Dindo classification and the EAU Intraoperative Adverse Incident Classification (EAUiaiC).
up to 30 days after surgery
Postoperative Complications
Time Frame: up to 24 months after surgery
Assessment of postoperative complications and long-term morbidity according to the Clavien-Dindo classification.
up to 24 months after surgery
Health-Related Quality of Life
Time Frame: Baseline and annually for 5 years
Quality of life assessed using the EORTC QLQ-C30 and EORTC QLQ-TC26 questionnaires. The EORTC QLQ-C30 is the core, 30-item questionnaire developed by the EORTC Quality of Life Group to evaluate the global health status and general quality of life of cancer patients. It is used alongside disease-specific modules, such as the EORTC QLQ-TC26, which is specifically designed for testicular cancer patients. The combination of these questionnaires ensures that clinicians and researchers capture both the general impacts of a cancer diagnosis and the specific issues pertinent to testicular cancer survivors.
Baseline and annually for 5 years
Technical Feasibility of Sentinel Lymph Node Biopsy
Time Frame: During surgery
Feasibility assessed by successful completion of the planned minimally invasive sentinel lymph node biopsy procedure according to the study protocol.
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 8, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAISN 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared outside the study team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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