Using fluorescein sodium to assist in vulvectomy for extramammary Paget's disease
A Single-Arm Prospective Trial of Fluorescein Mapping in Patients Undergoing Vulvectomy for Extramammary Paget's Disease
This study is testing if giving a special dye before surgery can help doctors find and remove cancerous cells more effectively in patients with extramammary Paget's disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06873815 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with noninvasive or microinvasive EMPD who are scheduled for vulvectomy.
Not a fit: Patients with a history of invasive EMPD or those requiring extensive surgical resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance surgical precision and outcomes for patients with extramammary Paget's disease.
How similar studies have performed: Other studies have shown promising results using fluorescein sodium in surgical settings, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Basking Ridge, New Jersey and 6 other locations
- 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)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.