Extramammary Paget's Disease
Conditions
Keywords
Fluorescein Mapping, Vulvectomy, 25-002
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).
Interventions
Patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a prospective single-arm intervention study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactMario Leitao, MD
Backup ContactEvan Smith, MD
Outcome results
None listed