Actively Recruiting
A Single-Arm Prospective Trial of Fluorescein Mapping in Patients Undergoing Vulvectomy for Extramammary Paget's Disease
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-01-12
27
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 Paget's 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.
CONDITIONS
Brief 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 18 years or older
- Diagnosed with noninvasive or microinvasive extramammary Paget's disease with a visible, contiguous clinical lesion
- Lesion may be newly diagnosed or recurrent
- Scheduled for wide local excision or vulvectomy without resection of the clitoris, urethra, or anus
- Surgeon must judge that primary closure or V-Y advancement flap closure is possible
You will not qualify if you...
- History of allergic reaction to fluorescein sodium
- Multifocal or noncontiguous clinical lesion
- Current or previous invasive extramammary Paget's disease
- History of invasive vulvar, vaginal, or anal cancer
- Lesion requiring resection of the clitoris, urethra, or anus
- Lesion where primary closure or V-Y advancement flap closure is not possible and larger myocutaneous flap is needed
- History of radiation therapy to the vulva and/or anus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 30 days post operation
Participants receive IV fluorescein sodium in the operating room prior to undergoing vulvectomy for extramammary Paget's disease. They are monitored for intraoperative and postoperative complications.
1 surgical procedure and post-operative monitoring visits
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
E
Evan Smith, MD
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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