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Lymph node sampling with a glowing dye to stage early testicular cancer

Tests dye-guided lymph node removal in men with early testicular cancer.

Key facts

Who runs it
Heinrich-Heine University, Duesseldorf
Where
Finland and Germany10 sites in 2 countriesChoose a country to see its sites
Trial code
Registry title
Minimally-invasive ICG-guided Retroperitoneal Sentinel Lymph Node Dissection in the Primary Staging of Testicular Cancer Versus Standard of Care
Status
Not yet recruiting
People taking part
171 people, planned
Starts
Jan 2027
Expected to end
Jan 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • ICG-Guided Retroperitoneal Sentinel Lymph Node Biopsy
  • Radical Inguinal Orchiectomy
Record updated
13 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with a suspected testicular germ cell tumor that has not spread on scans (clinical stage I). They must be able to have surgery to remove the testicle through the groin.

Age
18 years or older
Sex
Male only
Disease stage
Suspected testicular germ cell tumor, based on physical exam and scrotal ultrasound. No sign of spread on a contrast CT scan of the chest and abdomen (clinical stage I).
Earlier treatment
No earlier scrotal or retroperitoneal surgery unrelated to germ cell tumor treatment. Surgery for an undescended testicle in childhood is allowed. No earlier radiotherapy to the retroperitoneum, the area at the back of the belly.
Biomarker or test result
Blood tumor markers (AFP and/or β-hCG) may be raised or normal.

Main reasons for not taking part

  • Earlier cancer that needed belly surgery, chemotherapy or radiotherapy that could interfere with the study
  • Known allergy to indocyanine green (ICG), iodine or sodium iodide
  • Severe medical condition that rules out surgery or taking part
  • Psychiatric or other condition that stops you from following study steps
  • Not understanding German well enough, or being under legal guardianship

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Severe medical condition that precludes surgery or study participation
  • Psychiatric disorder or other condition preventing compliance with study procedures
  • Known hypersensitivity to indocyanine green (ICG), iodine, or sodium iodide
  • 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

This trial has no sites in United States.

It has sites in 2 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • ICG-Guided Sentinel Lymph Node Biopsy plus OrchiectomyTreatment being tested

    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.

    Treatment: ICG-Guided Retroperitoneal Sentinel Lymph Node Biopsy

  • Standard Orchiectomy and SurveillanceExisting treatment, for comparison

    Participants undergo radical inguinal orchiectomy followed by guideline-based surveillance according to current clinical practice.

    Treatment: Radical Inguinal Orchiectomy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Lymph node sampling with a glowing dye to stage early testicular cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
13 July 2026