Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)
- Conditions
- Sentinel Lymph NodeVulvar Cancer
- Registration Number
- NCT06029504
- Lead Sponsor
- Rigshospitalet, Denmark
- 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 \< 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 115
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sentinel Node detection rate Three years SN detection rate with ICG and 99mTc-Nanocoll alone perioperatively, where lymphoscintigraphy is blinded, in patients with vulvar cancer (tumor \< 4 cm) without clinical suspicion of metastases to the inguinal lymph nodes.
- Secondary Outcome Measures
Name Time Method Sensitivity, specificity, PPV and NPV Three years Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of FDG PET-CT and US combined with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in the groins
Trial Locations
- Locations (1)
Copenhagen University Hospital
🇩🇰Copenhagen, Denmark