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

8 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

171

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Finlandia
      • Helsinki, Finlandia, 00014
        • Helsinki University Hospital
      • Turku, Finlandia, 20520
        • University of Turku
        • Contatto:
  • Germania
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germania, 89081
    • Bavaria
      • Würzburg, Bavaria, Germania, 97080
        • University Hospital Würzburg
        • Contatto:
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Germania, 22763
        • Asklepios Klinik Altona
        • Contatto:
    • Hesse
      • Marburg, Hesse, Germania, 35043
    • North Rhine-Westphalia
    • Saxony
      • Dresden, Saxony, Germania, 01307
        • University Hospital Dresden
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: 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.
Comparatore attivo: Standard Orchiectomy and Surveillance
Participants undergo radical inguinal orchiectomy followed by guideline-based surveillance according to current clinical practice.
Procedura: Radical Inguinal Orchiectomy
Standard radical inguinal orchiectomy performed according to current clinical guidelines.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
2-Year Relapse-Free Survival (RFS)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival
Lasso di tempo: 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
Lasso di tempo: 24 months after randomization
Time from randomization to the first documented recurrence.
24 months after randomization
Rate of Salvage Therapy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: During surgery
Feasibility assessed by successful completion of the planned minimally invasive sentinel lymph node biopsy procedure according to the study protocol.
During surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Heinrich-Heine University, Duesseldorf

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 gennaio 2027

Completamento primario (Stimato)

1 gennaio 2029

Completamento dello studio (Stimato)

1 gennaio 2031

Date di iscrizione allo studio

Primo inviato

2 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RAISN 2

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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