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

RECRUITINGSponsored by Rigshospitalet, Denmark
Actively Recruiting
SponsorRigshospitalet, Denmark
Started2023-01-01
Est. completion2026-12-31
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06029504

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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)

Conditions3

CancerSentinel Lymph NodeVulvar Cancer

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