Minimally-invasive ICG-guided Retroperitoneal Sentinel Lymph Node Dissection in the Primary Staging of Testicular Cancer Versus Standard of Care (RAISN 2)
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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Peter Albers
- Numer telefonu: +49 211 81 18110
- E-mail: peter.albers@med.uni-duesseldorf.de
Kopia zapasowa kontaktu do badania
- Nazwa: Marieke Vermeulen-Spohn
- E-mail: mariekesofie.vermeulen@med.uni-duesseldorf.de
Lokalizacje studiów
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Helsinki, Finlandia, 00014
- Helsinki University Hospital
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Turku, Finlandia, 20520
- University of Turku
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Kontakt:
- Peter Boström
- Numer telefonu: +35823135925
- E-mail: peter.bostrom@tyks.fi
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Baden-Wurttemberg
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Ulm, Baden-Wurttemberg, Niemcy, 89081
- University Hospital Ulm
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Kontakt:
- Friedemann Zengerling
- Numer telefonu: +49731500-58004
- E-mail: carola.schmid@uniklinik-ulm.de
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Bavaria
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Würzburg, Bavaria, Niemcy, 97080
- University Hospital Würzburg
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Kontakt:
- Charis Kalogirou
- Numer telefonu: +49 931 201-32012
- E-mail: breitenste_a@ukw.de
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Free and Hanseatic City of Hamburg
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Hamburg, Free and Hanseatic City of Hamburg, Niemcy, 22763
- Asklepios Klinik Altona
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Kontakt:
- Christian Wülfing
- Numer telefonu: +49 40 1818-81 1661
- E-mail: c.wuelfing@asklepios.com
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Hesse
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Marburg, Hesse, Niemcy, 35043
- University Hospital Marbug
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Kontakt:
- Julia Heinzelbecker
- Numer telefonu: +49 64215866239
- E-mail: Julia.Heinzelbecker@uk-gm.de
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North Rhine-Westphalia
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Cologne, North Rhine-Westphalia, Niemcy, 50937
- University Hospital Cologne
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Kontakt:
- Axel Heidenreich
- Numer telefonu: +49 221 478-82108
- E-mail: kirsten.funke@uk-koeln.de
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Düsseldorf, North Rhine-Westphalia, Niemcy, 40225
- University Hospital Düsseldorf
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Kontakt:
- Peter Albers
- Numer telefonu: +49 211 81 18110
- E-mail: peter.albers@med.uni-duesseldorf.de
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Kontakt:
- Marieke Vermeulen
- E-mail: mariekesofie.vermeulen@med.uni-duesseldorf.de
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Główny śledczy:
- Peter Albers
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Wuppertal, North Rhine-Westphalia, Niemcy, 42283
- Helios University Hospital Wuppertal
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Kontakt:
- Friedrich von Rundstedt
- Numer telefonu: +49202 896-3407
- E-mail: friedrich.vonrundstedt@helios-gesundheit.de
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Saxony
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Dresden, Saxony, Niemcy, 01307
- University Hospital Dresden
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Kontakt:
- Christian Thomas
- Numer telefonu: +49 3514582447
- E-mail: christian.thomas@ukdd.de
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
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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.
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Aktywny komparator: Standard Orchiectomy and Surveillance
Participants undergo radical inguinal orchiectomy followed by guideline-based surveillance according to current clinical practice.
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Standard radical inguinal orchiectomy performed according to current clinical guidelines.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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2-Year Relapse-Free Survival (RFS)
Ramy czasowe: 24 months after randomization
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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.
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24 months after randomization
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Overall Survival
Ramy czasowe: 24 months after randomization
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Overall survival is defined as the time from randomization until death from any cause.
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24 months after randomization
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Time to Tumor Recurrence
Ramy czasowe: 24 months after randomization
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Time from randomization to the first documented recurrence.
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24 months after randomization
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Rate of Salvage Therapy
Ramy czasowe: 24 months after randomization
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Proportion of participants requiring salvage treatment including chemotherapy, retroperitoneal lymph node dissection, radiotherapy, or other oncological treatment.
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24 months after randomization
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Perioperative Morbidity
Ramy czasowe: up to 30 days after surgery
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Perioperative complications graded according to the Clavien-Dindo classification and the EAU Intraoperative Adverse Incident Classification (EAUiaiC).
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up to 30 days after surgery
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Postoperative Complications
Ramy czasowe: up to 24 months after surgery
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Assessment of postoperative complications and long-term morbidity according to the Clavien-Dindo classification.
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up to 24 months after surgery
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Health-Related Quality of Life
Ramy czasowe: Baseline and annually for 5 years
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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.
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Baseline and annually for 5 years
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Technical Feasibility of Sentinel Lymph Node Biopsy
Ramy czasowe: During surgery
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Feasibility assessed by successful completion of the planned minimally invasive sentinel lymph node biopsy procedure according to the study protocol.
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During surgery
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Peter Albers, Department of Urology, University Hospital of Heinrich Heine University, Düsseldorf
- Główny śledczy: Yue Che, University Hospital of Cologne
Publikacje i pomocne linki
Publikacje ogólne
- Vermeulen-Spohn MS, Pongratanakul P, Thy S, Dukart J, Albers P, Che Y. RAISN: Robot-assisted Indocyanine Green-guided Sentinel Node Biopsy in Clinical Stage I Germ Cell Tumor. Eur Urol Open Sci. 2024 Jun 27;66:55-59. doi: 10.1016/j.euros.2024.06.004. eCollection 2024 Aug.
- Albers P, Siener R, Krege S, Schmelz HU, Dieckmann KP, Heidenreich A, Kwasny P, Pechoel M, Lehmann J, Kliesch S, Kohrmann KU, Fimmers R, Weissbach L, Loy V, Wittekind C, Hartmann M; German Testicular Cancer Study Group. Randomized phase III trial comparing retroperitoneal lymph node dissection with one course of bleomycin and etoposide plus cisplatin chemotherapy in the adjuvant treatment of clinical stage I Nonseminomatous testicular germ cell tumors: AUO trial AH 01/94 by the German Testicular Cancer Study Group. J Clin Oncol. 2008 Jun 20;26(18):2966-72. doi: 10.1200/JCO.2007.12.0899. Epub 2008 May 5.
- Nayan M, Jewett MA, Hosni A, Anson-Cartwright L, Bedard PL, Moore M, Hansen AR, Chung P, Warde P, Sweet J, O'Malley M, Atenafu EG, Hamilton RJ. Conditional Risk of Relapse in Surveillance for Clinical Stage I Testicular Cancer. Eur Urol. 2017 Jan;71(1):120-127. doi: 10.1016/j.eururo.2016.07.013. Epub 2016 Aug 12.
- Tanis PJ, Horenblas S, Valdes Olmos RA, Hoefnagel CA, Nieweg OE. Feasibility of sentinel node lymphoscintigraphy in stage I testicular cancer. Eur J Nucl Med Mol Imaging. 2002 May;29(5):670-3. doi: 10.1007/s00259-001-0751-8. Epub 2002 Mar 5.
- Blok JM, Kerst JM, Vegt E, Brouwer OR, Meijer RP, Bosch JLHR, Bex A, van der Poel HG, Horenblas S. Sentinel node biopsy in clinical stage I testicular cancer enables early detection of occult metastatic disease. BJU Int. 2019 Sep;124(3):424-430. doi: 10.1111/bju.14618. Epub 2019 Mar 28.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu moczowo-płciowego
- Choroby narządów płciowych
- Choroby układu hormonalnego
- Nowotwory narządów płciowych, mężczyzna
- Nowotwory układu moczowo-płciowego
- Nowotwory według lokalizacji
- Nowotwory
- Choroby narządów płciowych, mężczyzna
- Choroby układu moczowo-płciowego u mężczyzn
- Nowotwory gruczołów dokrewnych
- Zaburzenia gonad
- Choroby jąder
- Nowotwory jąder
- Guz zarodkowy jąder
Inne numery identyfikacyjne badania
- RAISN 2
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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