A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a dye called fluorescein sodium in women who are scheduled to undergo vulvectomy surgery for a condition known as extramammary Paget's disease (EMPD). The main goal is to see if this dye can help surgeons spot cancer cells more effectively during the surgery. Researchers will also look into whether using fluorescein sodium leads to any complications during or after the surgery and if it can help identify areas that cannot be removed safely.

To participate in this study, women must be at least 18 years old and have a specific type of EMPD that is visible and can be surgically removed without affecting the clitoris, urethra, or anus. They should be newly diagnosed or have a recurring lesion. However, women who have had allergic reactions to fluorescein sodium, have more than one lesion that isn’t connected, or have a history of invasive cancer in the vulva, vagina, or anus may not be eligible. Participants can expect to receive an IV infusion of the dye before their surgery, and the study will closely monitor their experience throughout the process.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • Noninvasive or microinvasive EMPD with a contiguous visible clinical lesion
• • Newly diagnosed or recurrent lesion
• • Scheduled to undergo wide local excision or vulvectomy not requiring resection of the clitoris, urethra, or anus and with the surgeon's judgment that primary closure is possible (V-Y advancement flap closure is allowed)
• Exclusion Criteria:
• • History of allergic reaction to fluorescein sodium
• • Multifocal, noncontiguous clinical lesion
• • Current or previous invasive EMPD
• • History of invasive vulvar, vaginal, or anal cancer
• • Lesion in which resection of the clitoris, urethra, and/or anus is deemed to be necessary
• • Lesion in which a primary closure or V-Y advancement flap is believed not to be possible and a larger myocutaneous flap is needed for closure of the defect
• • History of radiation therapy to the vulva and/or anus

Trial Officials