RecruitingNCT06029504

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

Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer


Sponsor

Rigshospitalet, Denmark

Enrollment

115 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a technique called optical-guided sentinel node biopsy for women with vulvar cancer. A sentinel lymph node biopsy removes only the first lymph node(s) that cancer would spread to, avoiding a full lymph node removal. Using a special optical dye (ICG) and imaging, surgeons can find these nodes more precisely, potentially reducing complications from surgery. **You may be eligible if...** - You have been diagnosed with early-stage primary vulvar cancer (FIGO stage IB, tumor smaller than 4 cm) - Or you have a unifocal recurrence in the vulva (tumor smaller than 4 cm) on a side where you have not had prior groin surgery **You may NOT be eligible if...** - You have had prior radiation to the vulva or groin area - You have previously had a sentinel node biopsy or lymph node removal in the relevant groin - You have a known allergy to ICG dye or iodine 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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NCT06029504


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