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Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)

Recruitingn/aAges 18 Years - anyFemaleCopenhagen University Hospital, Rigshospitalet
NCT06029504 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

1 site
Copenhagen University Hospital
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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