A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)
- Registration Number
- NCT06873815
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 27
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD) Fluorescein Sodium Consented patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.
- Primary Outcome Measures
Name Time Method rate of positive pathologic surgical margin status 1 year is to determine whether the use of IV fluorescein sodium reduces the rate of positive surgical margins in patients undergoing vulvectomy for EMPD. The incidence of positive surgical margins on final pathology will be evaluated as the primary endpoint;
- Secondary Outcome Measures
Name Time Method incidence of intraoperative or postoperative complications up to 30 days post op all intraoperative and postoperative complications (including allergic reactions to fluorescein sodium injection, allergic reaction, infection, wound breakdown, need for reoperation) in the study population will be recorded prospectively. All complications of grade 3 or higher, as defined by Martin et al.10
Related Research Topics
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Trial Locations
- Locations (7)
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 Nassau (Limited Protocol Activities)
🇺🇸Uniondale, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
🇺🇸New York, New York, United States