A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)

Conditions

• Extramammary Paget's Disease

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fluorescein Sodium — DRUG
  Patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.

Study Details

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).

Key Dates

Start date

Mar 7, 2025

Status verified

Jan 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

27 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)
  Consented patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.

Primary Outcome Measure

rate of positive pathologic surgical margin status [ Time Frame: 1 year ]

Central Contacts

• Mario Leitao, MD
  212-639-3987
  [email protected]
• Evan Smith, MD
  212-639-2593

Locations (7)

Find similar trials in Basking Ridge, NJ

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