Status:
RECRUITING
A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Extramammary Paget's Disease
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 perfor...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Noninvasive or microinvasive EMPD with a contiguous visible clinical lesion
- Newly diagnosed or recurrent lesion
- Scheduled to undergo wide local excision or vulvectomy not requiring resection of the clitoris, urethra, or anus and with the surgeon's judgment that primary closure is possible (V-Y advancement flap closure is allowed)
Exclusion
- History of allergic reaction to fluorescein sodium
- Multifocal, noncontiguous clinical lesion
- Current or previous invasive EMPD
- History of invasive vulvar, vaginal, or anal cancer
- Lesion in which resection of the clitoris, urethra, and/or anus is deemed to be necessary
- Lesion in which a primary closure or V-Y advancement flap is believed not to be possible and a larger myocutaneous flap is needed for closure of the defect
- History of radiation therapy to the vulva and/or anus
Key Trial Info
Start Date :
March 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06873815
Start Date
March 7 2025
End Date
March 1 2027
Last Update
March 18 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725