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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether fluorescein sodium, a dye administered through an IV, can help surgeons better visualize cancer cells during surgery for extramammary Paget's disease, a rare skin cancer of the vulva. The goal is to determine if this aids in removing all diseased tissue and affects surgery safety and outcomes. It is suitable for individuals with a visible lesion of this disease who plan to undergo surgery that does not involve major areas like the clitoris. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that fluorescein sodium is likely to be safe for humans?

Research has shown that fluorescein sodium, administered through an IV, helps surgeons identify the edges of diseased cells in patients with Paget's disease of the vulva. In earlier studies, most participants tolerated this drug well, experiencing no severe side effects. While some may have mild side effects, serious problems are rare.

The trial's early phase indicates that past tests have demonstrated sufficient safety to warrant further study. This suggests the treatment is likely safe for participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Paget's disease of the vulva, which typically involve surgery or topical chemotherapy, fluorescein sodium offers a unique approach by acting as a fluorescent dye to help surgeons more accurately identify cancerous tissue during surgery. Researchers are excited about this treatment because it enhances the precision of surgical procedures, potentially leading to better outcomes and reducing the likelihood of cancer recurrence. By improving the visibility of affected areas, fluorescein sodium could make surgeries less invasive and more effective, providing a significant advancement over traditional methods.

What evidence suggests that fluorescein sodium is effective for identifying disease cells in Paget disease of the vulva?

Research has shown that fluorescein sodium holds promise for treating extramammary Paget's disease (EMPD). In this trial, participants undergoing vulvectomy will receive IV fluorescein sodium in the operating room. Administered through an IV, fluorescein sodium helps surgeons identify disease cells invisible to the naked eye, potentially allowing for more thorough removal during surgery. In one study, all patients had disease that spread beyond visible areas, and fluorescein sodium revealed these hidden regions. This could lead to more precise surgeries and improved outcomes for patients. ^{1 4 5 6 7}

Who Is on the Research Team?

Mario Leitao, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06873815?cond=PAGET%20DISEASE,%20EXTRAMAMMARY&rank=1

A Study of Fluorescein Sodium in People Undergoing ... 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36735397/

Fluorescein Mapping in Vulvar Paget Disease Using intravenous fluorescein sodium, all patients were found to have Paget disease beyond the visible margins of their gross lesions. No ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-02016

A Study of Fluorescein Sodium in People Undergoing ... This phase IV trial studies whether fluorescein sodium can be used to help surgeons identify tissue with cancer cells (cancerous tissue) that should be ...

4. researchgate.net researchgate.net/publication/368245242_Fluorescein_Mapping_in_Vulvar_Paget_Disease

Fluorescein Mapping in Vulvar Paget Disease Using intravenous fluorescein sodium, all patients were found to have Paget disease beyond the visible margins of their gross lesions. No ...

5. tau.amegroups.org tau.amegroups.org/article/view/28111/html

A primer on extramammary Paget's disease for the urologist Extramammary Paget's disease (EMPD) is a rare yet lethal cutaneous malignancy with an overall survival rate of 60.2% at 10 years postdiagnosis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10587701/

Fluorescein mapping for identification of residual satellite ... In conclusion, vulvar fluorescein mapping allows improved visualizing and highlighting of vulvar Paget's lesion boundaries compared to gross visualization and ...

7. withpower.com withpower.com/trial/phase-2-paget-disease-extramammary-2-2025-76c2f

Fluorescein Sodium for Paget Disease of the Vulva This Phase 2 medical study run by Memorial Sloan Kettering Cancer Center is evaluating whether Fluorescein Sodium will have tolerable side effects ...