NCT06029504 Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)
| NCT ID | NCT06029504 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Vulvar Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 115 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief Summary
The aim of this study is to investigate whether Sentinel Node biopsy can be performed without the use of lymphoscintigraphy and with ICG as a mono-tracer in women with vulvar cancer, unifocal tumor \< 4 cm (clinical stage IB and II). Further, to investigate the accuracy of combined PET-CT and ultrasound (US) of the groins with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in women with vulvar cancer, unifocal tumor \< 4 cm.
Eligibility Criteria
Inclusion Criteria: * Patients with primary vulva cancer, FIGO stage IB (tumor \< 4 cm) * Patients with unifocal recurrence in the vulva (tumor \< 4 cm) located on the side where the patient is surgically naïve in the groin Exclusion Criteria: * Prior irradiation of the vulva or groins * Prior SNB or inguinal lymphadenectomy in the relevant groin * Known allergy to ICG or iodine (ICG contains 5% sodium iodine)
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