Extramammary Paget's DiseasePhase 2NCT06873815
A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)
A Phase 2 study testing Fluorescein Sodium in people with Extramammary Paget's Disease, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Extramammary Paget's Disease
- What is being tested?
- Fluorescein Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 Mar 2025to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Evan Smith, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Mario Leitao, MD, 212-639-3987
- Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Mario Leitao, MD, 212-639-3987
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Mario Leitao, MD, 212-639-3987
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Mario Leitao, MD, 212-639-3987
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Mario Leitao, MD, 212-639-3987
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Mario Leitao, MD, 212-639-3987
Evan Smith, MD, 212-639-2593
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Mario Leitao, MD, 212-639-3987
About this study
Official title: 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).
- Conditions
- Extramammary Paget's Disease
- Being tested
- Fluorescein Sodium
- Keywords
- Fluorescein Mapping, Vulvectomy, 25-002
- Medical subject headings
- Paget Disease, Extramammary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescein SodiumDrug
Patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD) | Experimental | Consented patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure. Receives: Drug: Fluorescein Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 1 year
Secondary outcomes (1)
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
Measured: up to 30 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start7 Mar 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extramammary Paget's DiseaseStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective single-arm intervention study.
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario Leitao, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873815
- Sponsor's protocol ID
- 25-002
- Status last verified
- Jan 2026
- First submitted
- 7 Mar 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Prospective Trial of Fluorescein Mapping in Patients Undergoing Vulvectomy for Extramammary Paget's Disease
- ClinicalTrials.gov ID
- NCT06873815
- Acronym / sponsor ID
- 25-002
- Conditions
- Extramammary Paget's Disease
- Keywords
- Fluorescein Mapping, Vulvectomy, 25-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective single-arm intervention study.
| Arm | Type | Receives |
|---|---|---|
| Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD) | Experimental | Drug: Fluorescein SodiumConsented patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorescein SodiumPatients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure. | Drug | Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD) |
Primary outcome
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;
1 secondary outcome
incidence of intraoperative or postoperative complications
Time frame: up to 30 days post op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Extramammary Paget's Disease
Active, not recruitingPhase 2
Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers
Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive
RecruitingPhase 1
A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer
Cutaneous Squamous Cell Carcinoma, SCC - Squamous Cell Carcinoma
Active, not recruitingPhase 2
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Acinar Cell Carcinoma, Adenoid Cystic Carcinoma
Recruiting
PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).
Paget Disease of the Vulva, Paget Disease, Extramammary
RecruitingObservational study
Gynecologic Extramammary Paget's Disease
Extramammary Paget's Disease, Extramammary Paget Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evan Smith, MD contact
Mario Leitao, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluorescein Sodium in people with Extramammary Paget's Disease, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Leitao, MD (212-639-3987, leitaom@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of positive pathologic surgical margin status (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.