RecruitingNCT06029504
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer
Sponsor
Rigshospitalet, Denmark
Enrollment
115 participants
Start Date
Jan 1, 2023
Study Type
OBSERVATIONAL
Conditions
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
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria2
- 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 Criteria3
- 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)
Locations(1)
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NCT06029504
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