Actively Recruiting
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)
Led by Rigshospitalet, Denmark · Updated on 2023-12-06
115
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 naive in the groin
You will not qualify if you...
- Prior irradiation of the vulva or groins
- Prior Sentinel Node biopsy or inguinal lymphadenectomy in the relevant groin
- Known allergy to indocyanine green or iodine (ICG contains 5% sodium iodine)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Copenhagen University Hospital
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
L
Ligita P Frøding
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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