RecruitingNCT06161428

Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

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


Sponsor

Rigshospitalet, Denmark

Enrollment

100 participants

Start Date

May 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with vulva cancer tumour size \>4 cm, multifocal tumors and local recurrences.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at a surgical technique for vulvar cancer (cancer of the outer female genitalia) that uses a special fluorescent dye and light-guided imaging to find the "sentinel" lymph node — the first lymph node that cancer would spread to. This helps surgeons remove fewer lymph nodes and reduce complications. **You may be eligible if...** - You are an adult woman with early-stage vulvar cancer (Stage I–II) - Your tumor is limited in size and hasn't visibly spread to lymph nodes - You are scheduled for surgical treatment **You may NOT be eligible if...** - Your cancer has spread to the lymph nodes or beyond (advanced stage) - You have had prior surgery or radiation to the groin area - You are allergic to the dye used (ICG) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Copenhagen University Hospital

Copenhagen, Denmark

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NCT06161428


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