Germ Cell Tumor Clinical Trial
— RAISNOfficial 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.
Status | Recruiting |
Enrollment | 27 |
Est. completion date | October 31, 2026 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 99 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital of Duesseldorf | Duesseldorf |
Lead Sponsor | Collaborator |
---|---|
Heinrich-Heine University, Duesseldorf | Intuitive Foundation |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Complications | EAUiaiC-classification and Clavien Dindo | 2 years | |
Secondary | Retrograde ejaculation | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00369291 -
CpG 7909 in Treating Patients Who Have Undergone Autologous Stem Cell Transplant
|
Phase 1 | |
Terminated |
NCT00198172 -
Phase II Study of Cisplatin Plus Epirubicin Salvage Chemo in Refractory Germ Cell Tumors
|
Phase 2 | |
Recruiting |
NCT05874063 -
Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors
|
Phase 3 | |
Completed |
NCT03194906 -
Memantine for Prevention of Cognitive Late Effects in Pediatric Patients Receiving Cranial Radiation Therapy for Localized Brain Tumors
|
Phase 2 | |
Completed |
NCT01466231 -
Everolimus in Refractory Testicular Germ Cell Cancer
|
Phase 2 | |
Recruiting |
NCT04791228 -
A Pilot Study of Thermodox and MR-HIFU for Treatment of Relapsed Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03418844 -
Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy
|
N/A | |
Recruiting |
NCT05889585 -
Morbidity, Long-term Side Effects and Quality of Life in Germ-cell Tumor Long Survivors Treated With High-dose Chemotherapy and Autologous Stem Cell Transplant
|
||
Recruiting |
NCT05394675 -
A Study of DS-9606a in Patients With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT03067181 -
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
|
Phase 3 | |
Withdrawn |
NCT03960151 -
Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy
|
Phase 2 | |
Active, not recruiting |
NCT03158064 -
Evaluating Immune Therapy, Duravalumab (MEDI4736) With Tremelimumab for Relapsed/Refractory Germ Cell Tumors
|
Phase 2 | |
Completed |
NCT03950830 -
Disulfiram and Cisplatin in Refractory TGCTs.
|
Phase 2 | |
Recruiting |
NCT00898755 -
Collecting and Storing Tissue From Young Patients With Cancer
|
||
Recruiting |
NCT04804007 -
Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT
|
Phase 2 | |
Terminated |
NCT02988843 -
Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors
|
Phase 2 | |
Recruiting |
NCT05259605 -
Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 2021 WHO Classification
|
||
Active, not recruiting |
NCT03638167 -
EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric CNS Tumors
|
Phase 1 | |
Recruiting |
NCT04308330 -
Vorinostat in Combination With Chemotherapy in Relapsed/Refractory Solid Tumors and CNS Malignancies
|
Phase 1 | |
Recruiting |
NCT06418789 -
High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors
|
Phase 2 |