Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Copenhagen University Hospital
RECRUITING
Copenhagen
Contact Information
Primary
Ligita P Frøding
ligita.paskeviciute.froeding@regionh.dk
+4522722972
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 115
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark
Collaborators: Aarhus University Hospital

This content was sourced from clinicaltrials.gov

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