Actively Recruiting
A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-01-12
27
Participants Needed
7
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 18 years
- Noninvasive or microinvasive extramammary Paget's disease with a contiguous visible clinical lesion
- Newly diagnosed or recurrent lesion
- Scheduled for wide local excision or vulvectomy not requiring resection of the clitoris, urethra, or anus
- Surgeon judges primary closure possible; V-Y advancement flap closure is allowed
You will not qualify if you...
- History of allergic reaction to fluorescein sodium
- Multifocal, noncontiguous clinical lesion
- Current or previous invasive extramammary Paget's disease
- History of invasive vulvar, vaginal, or anal cancer
- Lesion requiring resection of clitoris, urethra, and/or anus
- Lesion where primary closure or V-Y advancement flap is not possible and larger flap is needed
- History of radiation therapy to the vulva and/or anus
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
M
Mario Leitao, MD
CONTACT
E
Evan Smith, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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