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โ† Trials
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A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)

RecruitingPhase 2Ages 18 Years - anyFemaleMemorial Sloan Kettering Cancer Center
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 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 Criteria: * 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
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What it tests

  • Fluorescein Sodium
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Where

7 sites
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, United States
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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