Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRigshospitalet, Denmark
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Rigshospitalet, Denmark
Lead sponsor
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov