Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Glow-in-the-Dark dye could simplify vulvar cancer surgery

NCT ID NCT06035068

Diagnosis Sponsor: Tufts Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study will test whether a fluorescent dye called indocyanine green (ICG), used with a special handheld camera, can find sentinel lymph nodes as well as the standard blue dye in early-stage vulvar cancer. Ten patients will receive both dyes during surgery, and doctors will compare how often each method spots the nodes. If ICG works just as well, it could make the procedure simpler and more accessible.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Indocyanine green (ICG) dye
What this could lead to
If it works, this could offer a simpler, less invasive way to map lymph nodes in vulvar cancer, potentially making the procedure easier for patients and doctors.
What could go wrong
This is a very small pilot study with only 10 participants, so results may not apply to everyone. The ICG method might not be as accurate as the standard blue dye approach.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Jan 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

10 participants fitting the above criteria at Tufts Medical Center

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18 years of age or older * Patients with early-stage SCC (diameter \<4 cm) of the vulva without suspicious lymph nodes at palpation or imaging who are planned for surgery at Tufts Medical Center. * Patients with squamous cell carcinoma, depth of invasion \> 1mm * Patients with T1 or T2 tumors (FIGO staging) \< 4 cm, not encroaching in urethra or anus with clinically negative inguinofemoral lymph nodes * Localization and size of the tumor are such that perilesional injection of the tracers at three or four sites is possible * Preoperative imaging do not show enlarged (\<1.5 cm)/ suspicious nodes * Willing and able to give informed consent Exclusion Criteria: * Inoperable tumors and tumors with diameter \> 4 cm * Patients with inguinofemoral lymph nodes that are palpable on clinical exam suspicious for metastases or with cytologically proven inguinofemoral lymph node metastases * Radiologically enlarged (\>1.5 cm) inguinofemoral lymph nodes * Patients with multifocal tumors * Pregnancy

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Early-stage vulvar squamous cell carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

vulva cancer vulvar squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Vulva cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.