NCT06873815

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
10mo left

Started Mar 2025

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Mar 2025Mar 2027

First Submitted

Initial submission to the registry

March 7, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

March 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

March 7, 2025

Last Update Submit

January 9, 2026

Conditions

Extramammary Paget's Disease

Keywords

Fluorescein MappingVulvectomy25-002

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • incidence of intraoperative or postoperative complications

    up to 30 days post op

Study Arms (1)

Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)

EXPERIMENTAL

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

Drug: Fluorescein Sodium

Interventions

Fluorescein SodiumDRUG

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

Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPeople Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

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

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Paget Disease, Extramammary

Interventions

Fluorescein

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

FluoresceinsSpiro CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsXanthenesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Mario Leitao, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Leitao, MD

CONTACT

212-639-3987leitaom@mskcc.org

Evan Smith, MD

CONTACT

212-639-2593

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: This is a prospective single-arm intervention study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 13, 2025

Study Start

March 7, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Locations

US(7)