Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

Launched by RIGSHOSPITALET, DENMARK · Nov 29, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new method to help doctors find lymph nodes that may have cancer in women with vulvar cancer, particularly those with larger tumors (over 4 cm), multiple tumors, or those who have had local recurrences. The study will use a combination of a special imaging technique called FDG-PET/CT and a method known as Sentinel Lymph Node mapping to see how well this approach works in these patients.

To be eligible for this trial, participants need to be women diagnosed with vulvar cancer and have either a tumor larger than 4 cm, multiple tumors, or local recurrences. However, women who have had previous radiation treatment in the area, prior surgery to remove sentinel nodes, an allergy to certain dyes used in imaging, or are currently being treated for another type of cancer cannot participate. If you join the study, you can expect to undergo specific imaging and mapping procedures to help assess the spread of cancer and guide future treatment options.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Patients with vulva cancer, tumor \> 4 cm, multifocal tumor, or local recurrences in vulva
• Exclusion Criteria:
• • Previous external irradiation of the vulva or groins
• • Former sentinel node or inguinal lymphadenectomy in the relevant groin
• • Known allergy to ICG or iodine
• • Patient is in active treatment for other cancer and/or disseminated disease