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NCT Number: NCT06873815

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

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).

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Key information

Conditions

Extramammary Paget's Disease Adenocarcinoma Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Paget Disease, Extramammary

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fluorescein sodium

Drug

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

Primary outcomes

  1. rate of positive pathologic surgical margin status

    Time frame: 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 outcomes

  1. incidence of intraoperative or postoperative complications

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Evan Smith, MD

CONTACT

212-639-2593

Mario Leitao, MD

CONTACT

[email protected]

212-639-3987

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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