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RecruitingInterventionalPhase 2

A Single-Arm Prospective Trial of Fluorescein Mapping in Patients Undergoing Vulvectomy for Extramammary Paget's Disease

NCT ID: NCT06873815Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-01-12

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).

Arms & interventions

  • DrugFluorescein Sodium

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

Outcome measures

Primary

  • rate of positive pathologic surgical margin status

    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;

    Time frame: 1 year

Secondary

  • incidence of intraoperative or postoperative complications

    Time frame: up to 30 days post op

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy 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

Study locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

Recruiting
Mario Leitao, MD · Contact

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

Recruiting
Mario Leitao, MD · Contact

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

Recruiting
Mario Leitao, MD · Contact

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

Commack, New York, 11725

Recruiting
Mario Leitao, MD · Contact

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

Recruiting
Mario Leitao, MD · Contact

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Recruiting
Mario Leitao, MD · Contact
Evan Smith, MD · Contact

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

Recruiting
Mario Leitao, MD · Contact
A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD) | Cancerify