A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)
NCT ID: NCT06873815
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
27 participants
INTERVENTIONAL
2025-03-07
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)
Consented patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.
Fluorescein Sodium
Patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.
Interventions
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Fluorescein Sodium
Patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Mario Leitao, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
Countries
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Central Contacts
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Evan Smith, MD
Role: CONTACT
Facility Contacts
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Mario Leitao, MD
Role: primary
Mario Leitao, MD
Role: primary
Mario Leitao, MD
Role: primary
Mario Leitao, MD
Role: primary
Mario Leitao, MD
Role: primary
Mario Leitao, MD
Role: primary
Evan Smith, MD
Role: backup
Mario Leitao, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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25-002
Identifier Type: -
Identifier Source: org_study_id
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