This phase IV trial studies whether fluorescein sodium can be used to help surgeons identify tissue with cancer cells (cancerous tissue) that should be removed during surgery to remove part or all of the vulva (vulvectomy) for extramammary Paget disease (EMPD). Typically, when patients undergo vulvectomy for EMPD, surgeons use standard light to identify cancerous tissue that should be removed. One challenge with this approach is that the disease can display irregular spread within the skin that cannot always be detected by the naked eye. Fluorescein sodium is a contrast dye given as an intravenous (IV) infusion into the vein. The dye lights up under ultraviolet light. Research has shown that fluorescein sodium builds up in areas where there is cancer. This may help surgeons identify cancerous tissue that should be removed during vulvectomy for EMPD.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06873815.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: Mario Mendes Leitao
Phone: 212-639-3987
PRIMARY OBJECTIVE:
I. To determine whether the use of IV fluorescein sodium injection (fluorescein sodium) for mapping immediately before vulvectomy reduces the rate of positive pathologic surgical margin status in patients undergoing vulvectomy for EMPD.
SECONDARY OBJECTIVES:
I. To determine the incidence of intraoperative or postoperative complications.
II. To determine the ability of IV fluorescein sodium to reveal disease that is not resectable with a 1-cm margin.
OUTLINE:
Patients receive fluorescein sodium IV and then undergo fluorescence imaging during standard of care (SOC) vulvectomy. Patients also undergo photography on study.
After completion of study intervention, patients are followed up at 30 days.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorMario Mendes Leitao
