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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Extramammary Paget's Disease
• Intervention / Treatment: Drug: Fluorescein Sodium

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mario Leitao, MD; Phone Number: 212-639-3987; Email: leitaom@mskcc.org
• Study Contact Backup: Name: Evan Smith, MD; Phone Number: 212-639-2593

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
      • Contact: Mario Leitao, MD; Phone Number: 212-639-3987
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
      • Contact: Mario Leitao, MD; Phone Number: 212-639-3987
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
      • Contact: Mario Leitao, MD; Phone Number: 212-639-3987
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
      • Contact: Mario Leitao, MD; Phone Number: 212-639-3987
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
      • Contact: Mario Leitao, MD; Phone Number: 212-639-3987
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Mario Leitao, MD; Phone Number: 212-639-3987
      • Contact: Evan Smith, MD; Phone Number: 212-639-2593
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
      • Contact: Mario Leitao, MD; Phone Number: 212-639-3987

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD); Consented patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.	Drug: Fluorescein Sodium; Patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of intraoperative or postoperative complications	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	up to 30 days post op

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Mario Leitao, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 13, 2025

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Fluorescein Mapping; Vulvectomy; 25-002
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Neoplasms, Ductal, Lobular, and Medullary; Paget Disease, Extramammary; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Polycyclic Compounds; Heterocyclic Compounds, 3-Ring; Spiro Compounds; Fluoresceins; Xanthenes; Fluorescein
• Other Study ID Numbers: 25-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No