NCT06873815

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

A Single-Arm Prospective Trial of Fluorescein Mapping in Patients Undergoing Vulvectomy for Extramammary Paget's Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The researchers are doing this study to see if giving people fluorescein sodium as an IV infusion before their vulvectomy for treating extramammary Paget's disease (EMPD) can help surgeons with performing the procedure. The researchers will look at whether fluorescein sodium helps surgeons identify disease cells that should be removed. Other purposes of this study include looking at the following: If there are any complications during or after vulvectomy involving the use of fluorescein sodium. If fluorescein sodium can reveal tissue that surgeons cannot operate on (unresectable tissue).

Conditions

• Extramammary Paget's Disease

Interventions

Type	Name	Description
DRUG	Fluorescein Sodium	Patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.

Timeline

• Start date: 2025-03-07
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-03-13
• Last updated: 2026-01-12

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study