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

Last updated: March 14, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Fluorescein Sodium

Clinical Study ID

NCT06873815
25-002
  • Ages > 18
  • Female

Study 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).

Eligibility Criteria

Inclusion

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 ofthe clitoris, urethra, or anus and with the surgeon's judgment that primary closureis possible (V-Y advancement flap closure is allowed)

Exclusion

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 benecessary

  • Lesion in which a primary closure or V-Y advancement flap is believed not to bepossible and a larger myocutaneous flap is needed for closure of the defect

  • History of radiation therapy to the vulva and/or anus

Study Design

Total Participants: 27
Treatment Group(s): 1
Primary Treatment: Fluorescein Sodium
Phase: 2
Study Start date:
March 07, 2025
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

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

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York 11553
    United States

    Active - Recruiting

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