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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center

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

Treatment groups

27 Participants
are divided into 1 treatment group