Status:
RECRUITING
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Aarhus University Hospital
Conditions:
Vulvar Cancer
Sentinel Lymph Node
Eligibility:
FEMALE
18+ years
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 \<...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT06029504
Start Date
January 1 2023
End Date
December 31 2027
Last Update
December 6 2023
Active Locations (1)
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1
Copenhagen University Hospital
Copenhagen, Denmark, 2100