Study of Fluorescein Sodium IV Before Vulvectomy to Help Detect Extramammary Pagets Disease

What this Trial Is About

Researchers are evaluating the use of fluorescein sodium given as an intravenous infusion before vulvectomy surgery in people with extramammary Pagets disease EMPD. The study aims to see if fluorescein sodium helps surgeons better identify disease cells that need to be removed and to assess any complications related to its use. It also explores whether fluorescein sodium can reveal tissue that cannot be surgically removed. This is a Phase 2 clinical trial sponsored by Memorial Sloan Kettering Cancer Center. Participants will receive an IV infusion of fluorescein sodium in the operating room before undergoing vulvectomy, a surgical procedure to remove disease tissue. The surgery will be performed on patients with noninvasive or microinvasive EMPD who have visible lesions and are scheduled for wide local excision or vulvectomy without the need to remove the clitoris, urethra, or anus. Closure of the surgical site will be primarily by direct closure or V-Y advancement flap. During the study, researchers will monitor the rate of positive surgical margins, meaning if disease cells remain at the edges of removed tissue, within one year after surgery. They will also track any complications occurring during or up to 30 days after the operation. Participants will be carefully observed and evaluated to understand the safety and surgical outcomes associated with the use of fluorescein sodium during vulvectomy for EMPD.

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