Testicular CancerRAISN 2NCT07699640
Minimally-invasive ICG-guided Retroperitoneal Sentinel Lymph Node Dissection in the Primary Staging of Testicular Cancer Versus Standard of Care
A study testing ICG-Guided Retroperitoneal Sentinel Lymph Node Biopsy and Radical Inguinal Orchiectomy in people with Testicular Cancer and Testicular Germ Cell Tumor, run by Heinrich-Heine University, Duesseldorf at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testicular Cancer, Testicular Germ Cell Tumor
- What is being tested?
- ICG-Guided Retroperitoneal Sentinel Lymph Node Biopsy and Radical Inguinal Orchiectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jan 2027to Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Marieke Vermeulen-Spohn contact
10 sites in 2 countries
Germany8 sites
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937
Axel Heidenreich, +49 221 478-82108, kirsten.funke@uk-koeln.de
University Hospital Dresden
Dresden, Saxony, 01307
Christian Thomas, +49 3514582447, christian.thomas@ukdd.de
University Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Peter Albers, +49 211 81 18110, peter.albers@med.uni-duesseldorf.de
Marieke Vermeulen, mariekesofie.vermeulen@med.uni-duesseldorf.de
Asklepios Klinik Altona
Hamburg, Free and Hanseatic City of Hamburg, 22763
Christian Wülfing, +49 40 1818-81 1661, c.wuelfing@asklepios.com
University Hospital Marbug
Marburg, Hesse, 35043
Julia Heinzelbecker, +49 64215866239, Julia.Heinzelbecker@uk-gm.de
University Hospital Ulm
Ulm, Baden-Wurttemberg, 89081
Friedemann Zengerling, +49731500-58004, carola.schmid@uniklinik-ulm.de
Helios University Hospital Wuppertal
Wuppertal, North Rhine-Westphalia, 42283
Friedrich von Rundstedt, +49202 896-3407, friedrich.vonrundstedt@helios-gesundheit.de
University Hospital Würzburg
Würzburg, Bavaria, 97080
Charis Kalogirou, +49 931 201-32012, breitenste_a@ukw.de
Finland2 sites
Helsinki University Hospital
Helsinki, 00014
University of Turku
Turku, 20520
Peter Boström, +35823135925, peter.bostrom@tyks.fi
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Testicular Cancer, Testicular Germ Cell Tumor
- Being tested
- ICG-Guided Retroperitoneal Sentinel Lymph Node Biopsy, Radical Inguinal Orchiectomy
- 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
- Medical subject headings
- Testicular Neoplasms, Testicular Germ Cell Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG-Guided Retroperitoneal Sentinel Lymph Node BiopsyProcedure or surgery
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.
Radical Inguinal OrchiectomyProcedure or surgery
Standard radical inguinal orchiectomy performed according to current clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Radical Inguinal Orchiectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months after randomization
Secondary outcomes (7)
Overall Survival
Overall survival is defined as the time from randomization until death from any cause.
Measured: 24 months after randomization
Time to Tumor Recurrence
Time from randomization to the first documented recurrence.
Measured: 24 months after randomization
Rate of Salvage Therapy
Proportion of participants requiring salvage treatment including chemotherapy, retroperitoneal lymph node dissection, radiotherapy, or other oncological treatment.
Measured: 24 months after randomization
Perioperative Morbidity
Perioperative complications graded according to the Clavien-Dindo classification and the EAU Intraoperative Adverse Incident Classification (EAUiaiC).
Measured: up to 30 days after surgery
Postoperative Complications
Assessment of postoperative complications and long-term morbidity according to the Clavien-Dindo classification.
Measured: up to 24 months after surgery
Health-Related Quality of Life
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.
Measured: Baseline and annually for 5 years
Technical Feasibility of Sentinel Lymph Node Biopsy
Feasibility assessed by successful completion of the planned minimally invasive sentinel lymph node biopsy procedure according to the study protocol.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Albers, Principal investigator, Department of Urology, University Hospital of Heinrich Heine University, DüsseldorfYue Che, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699640
- Sponsor's protocol ID
- RAISN 2
- Acronym
- RAISN 2
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the study team.
Publications
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.
PubMed 39036045Albers 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.
PubMed 18458040Nayan 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.
PubMed 27527805Tanis 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.
PubMed 11976806Blok 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.
PubMed 30417511
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07699640
- Acronym / sponsor ID
- RAISN 2 / RAISN 2
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ICG-Guided Sentinel Lymph Node Biopsy plus Orchiectomy | Experimental | Procedure: ICG-Guided Retroperitoneal Sentinel Lymph Node BiopsyParticipants 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. |
| Standard Orchiectomy and Surveillance | Active comparator | Procedure: Radical Inguinal OrchiectomyParticipants undergo radical inguinal orchiectomy followed by guideline-based surveillance according to current clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICG-Guided Retroperitoneal Sentinel Lymph Node BiopsyMinimally 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. | Procedure or surgery | ICG-Guided Sentinel Lymph Node Biopsy plus Orchiectomy |
| Radical Inguinal OrchiectomyStandard radical inguinal orchiectomy performed according to current clinical guidelines. | Procedure or surgery | Standard Orchiectomy and Surveillance |
Primary outcome
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.
7 secondary outcomes
Overall Survival
Time frame: 24 months after randomization
Time to Tumor Recurrence
Time frame: 24 months after randomization
Rate of Salvage Therapy
Time frame: 24 months after randomization
Perioperative Morbidity
Time frame: up to 30 days after surgery
Postoperative Complications
Time frame: up to 24 months after surgery
Health-Related Quality of Life
Time frame: Baseline and annually for 5 years
Technical Feasibility of Sentinel Lymph Node Biopsy
Time frame: During surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 39036045Vermeulen-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.
- Background: PubMed 18458040Albers 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.
- Background: PubMed 27527805Nayan 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.
- Background: PubMed 11976806Tanis 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.
- Background: PubMed 30417511Blok 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marieke Vermeulen-Spohn contact
Peter Albers principal investigator
Department of Urology, University Hospital of Heinrich Heine University, Düsseldorf
Yue Che principal investigator
University Hospital of Cologne
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG-Guided Retroperitoneal Sentinel Lymph Node Biopsy and Radical Inguinal Orchiectomy in people with Testicular Cancer and Testicular Germ Cell Tumor, run by Heinrich-Heine University, Duesseldorf at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Albers (+49 211 81 18110, peter.albers@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-Year Relapse-Free Survival (RFS) (time frame: 24 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07699640, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.