Using fluorescein sodium to assist in vulvectomy for extramammary Paget's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of fluorescein sodium administered as an IV infusion prior to vulvectomy in patients with extramammary Paget's disease (EMPD). The goal is to determine if fluorescein sodium can help surgeons identify cancerous cells that need to be removed during the procedure. Additionally, the study will assess any complications arising from the use of fluorescein sodium and its effectiveness in revealing tissue that cannot be surgically removed. This phase 2 interventional study aims to improve surgical outcomes for patients undergoing treatment for EMPD.

Why it matters

Who can join: the full rules

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

Where it's running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Mario Leitao, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Mario Leitao, MD
• Email: leitaom@mskcc.org
• Phone: 212-639-3987

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Disitamab Vedotin plus bicalutamide for HER2/AR-positive scrotal Paget disease

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.