A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)
Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Mar 11, 2025
Trial Information
Current as of April 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of a dye called fluorescein sodium in women who are scheduled to undergo vulvectomy surgery for a condition known as extramammary Paget's disease (EMPD). The main goal is to see if this dye can help surgeons spot cancer cells more effectively during the surgery. Researchers will also look into whether using fluorescein sodium leads to any complications during or after the surgery and if it can help identify areas that cannot be removed safely.
To participate in this study, women must be at least 18 years old and have a specific type of EMPD that is visible and can be surgically removed without affecting the clitoris, urethra, or anus. They should be newly diagnosed or have a recurring lesion. However, women who have had allergic reactions to fluorescein sodium, have more than one lesion that isn’t connected, or have a history of invasive cancer in the vulva, vagina, or anus may not be eligible. Participants can expect to receive an IV infusion of the dye before their surgery, and the study will closely monitor their experience throughout the process.
Gender
FEMALE
Eligibility 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
Trial Officials
Mario Leitao, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
About Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center (MSKCC) is a world-renowned institution dedicated to cancer treatment, research, and education. As a leading clinical trial sponsor, MSKCC focuses on advancing innovative cancer therapies through rigorous scientific investigation and collaboration. The center's multidisciplinary team of experts employs cutting-edge methodologies to design and conduct trials that aim to improve patient outcomes and enhance understanding of cancer biology. With a commitment to translating research findings into clinical practice, MSKCC plays a pivotal role in shaping the future of oncology care and ensuring that patients have access to the latest therapeutic advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Basking Ridge, New Jersey, United States
Middletown, New Jersey, United States
Montvale, New Jersey, United States
Commack, New York, United States
Harrison, New York, United States
Uniondale, New York, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported