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

Rigshospitalet

Status: Enrolling

Conditions: Sentinel Lymph Node; Vulvar Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06029504

H-18020235

Details and patient eligibility

About

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.

Enrollment: 115 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)