Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer (RAISN)

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.

Study Overview

• Status: Recruiting
• Conditions: Nonseminomatous Germ Cell Tumor; Seminoma; Germ Cell Tumor
• Intervention / Treatment: Procedure: Robot-assisted ICG-guided sentinel lymph node biopsy

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 Type: Interventional
• Enrollment (Estimated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yue Che; Phone Number: 00492118118110; Email: yue.che@med.uni-duesseldorf.de

Study Locations

• Germany
  • Duesseldorf, Germany
    • Recruiting
    • University Hospital of Duesseldorf
    • Contact: Yue Che; Phone Number: 00492118118110; Email: yue.che@med.uni-duesseldorf.de
    • Contact: Peter Albers; Email: peter.albers@med.uni-duesseldorf.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Negative sentinel lymph node; Patients with negative sentinel lymph node biopsy are enrolled to active surveillance after surgery	Procedure: Robot-assisted ICG-guided sentinel lymph node biopsy; 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.
Experimental: Positive sentinel lymph node; Patients with positive lymph node biopsy undergo a template retroperitoneal lymph node dissection in the same procedure	Procedure: Robot-assisted ICG-guided sentinel lymph node biopsy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	EAUiaiC-classification and Clavien Dindo	2 years
Retrograde ejaculation		2 years

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Collaborators: Intuitive Foundation

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Testicular Diseases; Germinoma; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms; Seminoma
• Other Study ID Numbers: 2023-2328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No