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

NCT07699640 | Not Yet Recruiting

• 1 other identifier: RAISN 2
• Study Type: interventional
• Target: 171
• Locations: 2 countries
• Sites: 10

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

Keywords

Testicular Cancer; Testicular Germ Cell Tumor; Stage I Testicular Cancer; Sentinel Lymph Node Biopsy; Sentinel Lymph Node Mapping; Indocyanine Green; ICG; Retroperitoneal Lymph Nodes; Minimally Invasive Surgery; Robot-Assisted Surgery; Active Surveillance

Outcome Measures

Primary Outcomes (1)

• 2-Year Relapse-Free Survival (RFS)

  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 Outcomes (7)

• Overall Survival

  24 months after randomization

• Time to Tumor Recurrence

  24 months after randomization

• Rate of Salvage Therapy

  24 months after randomization

• Perioperative Morbidity

  up to 30 days after surgery

• Postoperative Complications

  up to 24 months after surgery

Study Arms (2)

ICG-Guided Sentinel Lymph Node Biopsy plus Orchiectomy

EXPERIMENTAL

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

Standard Orchiectomy and Surveillance

ACTIVE COMPARATOR

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

Procedure: Radical Inguinal Orchiectomy

Interventions

ICG-Guided Retroperitoneal Sentinel Lymph Node Biopsy PROCEDURE

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.

ICG-Guided Sentinel Lymph Node Biopsy plus Orchiectomy

Radical Inguinal Orchiectomy PROCEDURE

Standard radical inguinal orchiectomy performed according to current clinical guidelines.

Standard Orchiectomy and Surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (10)

Helsinki University Hospital

Helsinki, 00014, Finland

Location

University of Turku

Turku, 20520, Finland

Location

University Hospital Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

University Hospital Würzburg

Würzburg, Bavaria, 97080, Germany

Location

Asklepios Klinik Altona

Hamburg, Free and Hanseatic City of Hamburg, 22763, Germany

Location

University Hospital Marbug

Marburg, Hesse, 35043, Germany

Location

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

University Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Helios University Hospital Wuppertal

Wuppertal, North Rhine-Westphalia, 42283, Germany

Location

University Hospital Dresden

Dresden, Saxony, 01307, Germany

Location

Related Publications (5)

• 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.

  PMID: 39036045 BACKGROUND

• 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.

  PMID: 18458040 BACKGROUND

• 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.

  PMID: 27527805 BACKGROUND

• 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.

  PMID: 11976806 BACKGROUND

• 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.

  PMID: 30417511 BACKGROUND

MeSH Terms

Conditions

Testicular Neoplasms; Testicular Germ Cell Tumor

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• Peter Albers

  Department of Urology, University Hospital of Heinrich Heine University, Düsseldorf

  PRINCIPAL INVESTIGATOR

• Yue Che

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Albers

CONTACT

+49 211 81 18110; peter.albers@med.uni-duesseldorf.de

Marieke Vermeulen-Spohn

CONTACT

mariekesofie.vermeulen@med.uni-duesseldorf.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the surgical intervention, blinding of participants and investigators is not feasible. Outcome assessment is based on predefined clinical, radiological, and pathological criteria.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2031
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8); FI (2)