About this trial
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).
Eligibility criteria
Qualifiers
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)
Disqualifiers
History of allergic reaction to fluorescein sodium
Multifocal, noncontiguous clinical lesion
Current or previous invasive EMPD
History of invasive vulvar, vaginal, or anal cancer
Trial design
Treatments tested in this trial
- Fluorescein Sodium