Fluorescein Sodium for Paget Disease of the Vulva

Recruiting at 6 trial locations

Overseen By Evan Smith, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Allergy to fluorescein, Invasive EMPD, Invasive cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

27 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Mario Leitao, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for individuals undergoing vulvectomy to treat extramammary Paget's disease (EMPD). Participants must meet specific health criteria set by the researchers, but these have not been detailed in the provided information.

Inclusion Criteria

My skin cancer is on the surface or slightly deeper and can be seen.

I am scheduled for a surgery on my vulva that won't affect my clitoris, urethra, or anus, and can be closed up primarily.

My cancer is either newly found or has come back.

Exclusion Criteria

I have had radiation therapy to the vulva or anus.

I have a history of cancer in the vulva, vagina, or anus.

I have multiple, separate cancer lesions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IV fluorescein sodium before undergoing vulvectomy for EMPD

1 day

1 visit (in-person)

Follow-up

Participants are monitored for intraoperative and postoperative complications, including allergic reactions and wound healing

4 weeks

1-2 visits (in-person)

Long-term Follow-up

Participants are monitored for the rate of positive pathologic surgical margin status

1 year

Treatment Details

Interventions

• Fluorescein Sodium

Trial Overview The study tests if fluorescein sodium given via IV can help surgeons see cancer cells better during a vulvectomy. It also examines potential complications and whether it highlights unresectable tissue.

Participant Groups

Group I: Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD) Experimental Treatment 1 Intervention

Consented patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+