What this study is
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).
What's being tested
- Fluorescein Sodium
Intervention · DRUG
Patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.
Study details
- Official title
- A Single-Arm Prospective Trial of Fluorescein Mapping in Patients Undergoing Vulvectomy for Extramammary Paget's Disease
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Extramammary Paget's Disease
- Enrolling
- 27 people
- Starts
- 2025-03-07
- Est. completion
- 2027-03
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (7)
7 openContact for every open site
- Mario Leitao, MD · Contact212-639-3987
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
RecruitingMemorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
RecruitingMemorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
RecruitingMemorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States
RecruitingMemorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
RecruitingMemorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
- Evan Smith, MD · Contact212-639-2593
RecruitingMemorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
Recruiting
Study team
Sponsor
Memorial Sloan Kettering Cancer Center
Study ID 25-002
Principal investigator
Mario Leitao, MD
Memorial Sloan Kettering Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.