Recruiting
Phase 2

Fluorescein Sodium

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06873815

Conditions

Extramammary Paget's Disease

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fluorescein Sodium

Study Details

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).

Conditions

Extramammary Paget's Disease

Study ID

NCT06873815

Start date

Mar 7, 2025

Status verified date

Jan, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

27 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)

Consented patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.

Interventions

Fluorescein Sodium

Patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.

Primary outcome measure

  • rate of positive pathologic surgical margin status [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Mario Leitao, MD

212-639-3987leitaom@mskcc.org

Evan Smith, MD

212-639-2593

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Mario Leitao, MD

212-639-3987

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Mario Leitao, MD

212-639-3987

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Mario Leitao, MD

212-639-3987

Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Mario Leitao, MD

212-639-3987

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Mario Leitao, MD

212-639-3987

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Mario Leitao, MD

212-639-3987

Evan Smith, MD

212-639-2593

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Mario Leitao, MD

212-639-3987

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Keywords

  • Fluorescein Mapping
  • Vulvectomy
  • 25-002

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-01-12.