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

Recruiting now

Conditions studied: Vulvar Cancer, Sentinel Lymph Node

In brief

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.

Key facts

Study ID

NCT06029504

Run by

Rigshospitalet, Denmark

People needed

115

Starts

2023-01-01

Expected to finish

2027-12-31

Last updated by the study team

2023-12-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Copenhagen University Hospital — Copenhagen, Denmark (enrolling)

Full record on ClinicalTrials.gov

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