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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Enrolling

Phase 2

Conditions

Extramammary Paget's Disease

Treatments

Drug: Fluorescein Sodium

Study type

Interventional

Funder types

Other

Identifiers

NCT06873815

25-002

Details and patient eligibility

About

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).

Enrollment

27 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

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