About this trial
This study looks at how giving fluorescein sodium before vulvectomy helps surgeons during the procedure for extramammary Paget's disease. Researchers want to see if this medicine helps find disease cells that need to be removed. They will also check for any complications and whether it shows areas that can't be operated on.
This is a Phase 2 trial, which means it is studying how well the treatment works and its safety. The trial is FDA-regulated and aims to include 27 participants.
Who can join
You can join if you are at least 18 years old and have a specific type of skin condition called extramammary Paget's disease. This study is only for women who are scheduled for vulvectomy surgery. If you have had an allergic reaction to fluorescein sodium or other certain health issues, you may not be able to participate. The trial team will confirm your eligibility.
Condition
Extramammary Paget's Disease
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
All participants will receive fluorescein sodium through an IV in the operating room before their vulvectomy. This is a single group study, so everyone gets the treatment. The main goal is to see how well this helps with the surgery.
Where
This trial is running at 7 locations in the United States. All of them are currently recruiting.
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York