Germ Cell TumorRAISNNCT06133543
Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
A study testing Robot-assisted ICG-guided sentinel lymph node biopsy in people with Germ Cell Tumor and Seminoma, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Robot-assisted image-guided sentinel lymph node biopsy (RAISN) in testicular cancer is a novel technique that has not been widely investigated yet. This technique is promising and could be implemented as a future standard in the primary diagnostic work up of clinical stage (CS) I testicular cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Germ Cell Tumor, Seminoma, Nonseminomatous Germ Cell Tumor
- What is being tested?
- Robot-assisted ICG-guided sentinel lymph node biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 6 Sep 2023to 31 Mar 2028
- 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 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically confirmed unequivocal testicular tumor by palpation and sonography with or without elevation of specific tumor markers AFP and/or ß-HCG.
- Clinical exclusion of metastases in preoperative staging using contrast-enhanced CT of the thorax and abdomen.
- The patient is of legal age.
- The patient can communicate with the investigator without issues or limitations and can understand and sign the patient information and consent form without problems or limitations.
Who cannot join
- Testicular tumor with uncertain dignity
- Patients with small testicular masses (< 1 cm)
- Patients with prior scrotal or retroperitoneal surgery for reasons other than a germ cell tumor.
- The patient has received different chemotherapy.
- The patient has undergone retroperitoneal radiotherapy.
- Exclusion criteria for the use of ICG include a history of anaphylactic reactions to ICG and iodine intolerance (ICG solution contains sodium iodide).
- The patient is in a reduced general condition or has a life-threatening illness.
- The patient has a psychiatric illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Duesseldorf
Düsseldorf
Yue Che, 00492118118110, yue.che@med.uni-duesseldorf.de
Peter Albers, peter.albers@med.uni-duesseldorf.de
About this study
Official title: RAISN - Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
Robot-assisted image-guided sentinel lymph node biopsy (RAISN) in testicular cancer is a novel technique that has not been widely investigated yet. This technique is promising and could be implemented as a future standard in the primary diagnostic work up of clinical stage (CS) I testicular cancer. Current staging strategies have a poor predictive accuracy for occult metastatic disease.
So far, feasibility studies used 99mTC-nanocolloid staining and laparoscopy and all patients with tumor-positive nodes received adjuvant systemic treatment. The development of a robot-assisted image-guided lymph node resection technique with indocyanine green (ICG) is potentially more precise, easier to apply and widely available. With this new diagnostic approach the management of newly diagnosed testicular cancer patients might be changed dramatically by reducing overtreatment and treatment-related toxicity with a minimally invasive robot-assisted procedure.
Read the detailed description
The sentinel lymph node biopsy in testicular cancer is a novel technique that has not been extensively studied. This technique shows promise and could potentially become the future standard in the primary diagnosis of testicular cancer in clinical stage I.
In cases of clinical stage I testicular cancer, 20% to 30% of patients experience a recurrence. Strategies such as adjuvant chemotherapy or retroperitoneal lymph node dissection can reduce the risk of recurrence to 2% and 9%, respectively. However, the issue with these strategies is that the majority of patients may receive unnecessary treatment and endure the toxicity of chemotherapy or surgery. German and European guidelines recommend a risk-adapted approach. Testicular tumor patients with specific histopathological features are classified into low and high risk, with adjuvant therapy recommended accordingly. This strategy allows for more targeted treatment but still maintains a limited sensitivity of approximately 73%.
There have been few studies investigating the possibility of sentinel lymph node diagnostics in testicular cancer. Reasons for this include the rarity of the disease coupled with a lack of experience in minimally invasive surgery for testicular cancer treatment. Previous sentinel lymph node studies utilized the radioligand technique with technetium, which was limited to centers with a nuclear medicine department. With the advancing development of robotics and fluorescence technology using indocyanine green, there is an opportunity for a novel, minimally invasive lymph node diagnostic method applicable on a broader scale for testicular cancer patients.
In previous feasibility studies on sentinel lymph node diagnostics in testicular tumor patients, the use of 99mTC-nanocolloid staining and laparoscopy achieved a 90% sensitivity. The development of a robot-assisted image-guided lymph node resection technique using indocyanine green (ICG) is potentially more precise, easier to apply, and generally more available. Multiple studies in other tumor entities have demonstrated the non-inferiority and superiority of ICG over technetium. This new diagnostic approach could drastically change the treatment for newly diagnosed testicular cancer patients by reducing overtreatment and treatment-related toxicity through a minimally invasive robot-assisted procedure.
- Conditions
- Germ Cell Tumor, Seminoma, Nonseminomatous Germ Cell Tumor
- Being tested
- Robot-assisted ICG-guided sentinel lymph node biopsy
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal, Seminoma, Nonseminomatous germ cell tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted ICG-guided sentinel lymph node biopsyProcedure or surgery
The robot-assisted ICG-guided sentinel node (SN) biopsy is conducted as follows: At the start of the operation, indocyanine green (ICG) solution is transscrotally injected into the testicular parenchyma. The patient is positioned in the nephrectomy posture. After port placement and docking of the robotic system, the sentinel node(s) should be visible with the fluorescence camera. The SN is removed and sent for immediate frozen section biopsy evaluation. The inguinal orchiectomy is performed subsequently until the biopsy results are available. If the biopsy is negative, the procedure concludes. If the biopsy shows viable tumor, indicating clinical stage IIA and the indication for systematic unilateral retroperitoneal lymph node dissection. The patient was informed about the potential expansion of the procedure upon study enrollment. After the procedure, all patients are placed under observation and do not receive adjuvant systemic treatment. The follow-up period extends to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Negative sentinel lymph node | Experimental | Patients with negative sentinel lymph node biopsy are enrolled to active surveillance after surgery Receives: Procedure: Robot-assisted ICG-guided sentinel lymph node biopsy |
| Positive sentinel lymph node | Experimental | Patients with positive lymph node biopsy undergo a template retroperitoneal lymph node dissection in the same procedure Receives: Procedure: Robot-assisted ICG-guided sentinel lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
The primary endpoint of the study is to demonstrate that RAISN has a sensitivity of ≥ 90% in nodal staging for testicular tumors in clinical stage I.
Measured: 2 years
Secondary outcomes (2)
Complications
EAUiaiC-classification and Clavien Dindo
Measured: 2 years
Retrograde ejaculation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start6 Sep 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- Intuitive Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133543
- Sponsor's protocol ID
- 2023-2328
- Acronym
- RAISN
- Status last verified
- Mar 2025
- First submitted
- 10 Nov 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAISN - Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
- ClinicalTrials.gov ID
- NCT06133543
- Acronym / sponsor ID
- RAISN / 2023-2328
- Conditions
- Germ Cell Tumor, Seminoma, Nonseminomatous Germ Cell Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- Intuitive Foundation
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 15 Nov 2023 (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.
Robot-assisted image-guided sentinel lymph node biopsy (RAISN) in testicular cancer is a novel technique that has not been widely investigated yet. This technique is promising and could be implemented as a future standard in the primary diagnostic work up of clinical stage (CS) I testicular cancer. Current staging strategies have a poor predictive accuracy for occult metastatic disease.
So far, feasibility studies used 99mTC-nanocolloid staining and laparoscopy and all patients with tumor-positive nodes received adjuvant systemic treatment. The development of a robot-assisted image-guided lymph node resection technique with indocyanine green (ICG) is potentially more precise, easier to apply and widely available. With this new diagnostic approach the management of newly diagnosed testicular cancer patients might be changed dramatically by reducing overtreatment and treatment-related toxicity with a minimally invasive robot-assisted procedure.
Detailed description
The sentinel lymph node biopsy in testicular cancer is a novel technique that has not been extensively studied. This technique shows promise and could potentially become the future standard in the primary diagnosis of testicular cancer in clinical stage I.
In cases of clinical stage I testicular cancer, 20% to 30% of patients experience a recurrence. Strategies such as adjuvant chemotherapy or retroperitoneal lymph node dissection can reduce the risk of recurrence to 2% and 9%, respectively. However, the issue with these strategies is that the majority of patients may receive unnecessary treatment and endure the toxicity of chemotherapy or surgery. German and European guidelines recommend a risk-adapted approach. Testicular tumor patients with specific histopathological features are classified into low and high risk, with adjuvant therapy recommended accordingly. This strategy allows for more targeted treatment but still maintains a limited sensitivity of approximately 73%.
There have been few studies investigating the possibility of sentinel lymph node diagnostics in testicular cancer. Reasons for this include the rarity of the disease coupled with a lack of experience in minimally invasive surgery for testicular cancer treatment. Previous sentinel lymph node studies utilized the radioligand technique with technetium, which was limited to centers with a nuclear medicine department. With the advancing development of robotics and fluorescence technology using indocyanine green, there is an opportunity for a novel, minimally invasive lymph node diagnostic method applicable on a broader scale for testicular cancer patients.
In previous feasibility studies on sentinel lymph node diagnostics in testicular tumor patients, the use of 99mTC-nanocolloid staining and laparoscopy achieved a 90% sensitivity. The development of a robot-assisted image-guided lymph node resection technique using indocyanine green (ICG) is potentially more precise, easier to apply, and generally more available. Multiple studies in other tumor entities have demonstrated the non-inferiority and superiority of ICG over technetium. This new diagnostic approach could drastically change the treatment for newly diagnosed testicular cancer patients by reducing overtreatment and treatment-related toxicity through a minimally invasive robot-assisted procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative sentinel lymph node | Experimental | Procedure: Robot-assisted ICG-guided sentinel lymph node biopsyPatients with negative sentinel lymph node biopsy are enrolled to active surveillance after surgery |
| Positive sentinel lymph node | Experimental | Procedure: Robot-assisted ICG-guided sentinel lymph node biopsyPatients with positive lymph node biopsy undergo a template retroperitoneal lymph node dissection in the same procedure |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically confirmed unequivocal testicular tumor by palpation and sonography with or without elevation of specific tumor markers AFP and/or ß-HCG.
- Clinical exclusion of metastases in preoperative staging using contrast-enhanced CT of the thorax and abdomen.
- The patient is of legal age.
- The patient can communicate with the investigator without issues or limitations and can understand and sign the patient information and consent form without problems or limitations.
Key exclusion criteria (8 listed)
- Testicular tumor with uncertain dignity
- Patients with small testicular masses (< 1 cm)
- Patients with prior scrotal or retroperitoneal surgery for reasons other than a germ cell tumor.
- The patient has received different chemotherapy.
- The patient has undergone retroperitoneal radiotherapy.
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 |
|---|---|---|
| Robot-assisted ICG-guided sentinel lymph node biopsyThe robot-assisted ICG-guided sentinel node (SN) biopsy is conducted as follows: At the start of the operation, indocyanine green (ICG) solution is transscrotally injected into the testicular parenchyma. The patient is positioned in the nephrectomy posture. After port placement and docking of the robotic system, the sentinel node(s) should be visible with the fluorescence camera. The SN is removed and sent for immediate frozen section biopsy evaluation. The inguinal orchiectomy is performed subsequently until the biopsy results are available. If the biopsy is negative, the procedure concludes. If the biopsy shows viable tumor, indicating clinical stage IIA and the indication for systematic unilateral retroperitoneal lymph node dissection. The patient was informed about the potential expansion of the procedure upon study enrollment. After the procedure, all patients are placed under observation and do not receive adjuvant systemic treatment. The follow-up period extends to 2 years. | Procedure or surgery | Negative sentinel lymph node, Positive sentinel lymph node |
Primary outcome
Sensitivity
Time frame: 2 years
The primary endpoint of the study is to demonstrate that RAISN has a sensitivity of ≥ 90% in nodal staging for testicular tumors in clinical stage I.
2 secondary outcomes
Complications
Time frame: 2 years
Retrograde ejaculation
Time frame: 2 years
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 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted ICG-guided sentinel lymph node biopsy in people with Germ Cell Tumor and Seminoma, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 4 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: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 Yue Che (00492118118110, yue.che@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2025.