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Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer

ConditionsGerm Cell TumorSeminomaNonseminomatous Germ Cell Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-99
SponsorHeinrich-Heine University, Duesseldorf

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Robot-assisted ICG-guided sentinel lymph node biopsy

    Procedure/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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Negative sentinel lymph nodeExperimental treatment 1 intervention
Group B: Positive sentinel lymph nodeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years

Secondary outcomes

1

Complications

EAUiaiC-classification and Clavien Dindo

Time frame
2 years
2

Retrograde ejaculation

Time frame
2 years

Other outcomes

Sponsors and contacts

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Heinrich-Heine University, Duesseldorf

Lead sponsor

Intuitive Foundation

Collaborator

Source ClinicalTrials.gov
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