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New dye could replace radioactive tracers in vulvar cancer surgery

NCT ID NCT06127836

Diagnosis Sponsor: Memorial Sloan Kettering Cancer 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a dye called indocyanine green (ICG) used with near-infrared imaging can find sentinel lymph nodes as well as the standard radioactive tracer method in people with early-stage vulvar cancer. About 22 participants will receive both methods during surgery to see if ICG works just as well. If it does, it could offer a simpler, radiation-free option for guiding surgery.

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) injection
What this could lead to
If successful, ICG near-infrared imaging could replace the current standard, making sentinel lymph node detection faster and avoiding radioactive tracers.
What could go wrong
This is a small, early-phase study with only 22 participants, so results may not apply to all patients. The technique may not be as accurate as the current method.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

22 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Nov 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.

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 * Newly diagnosed with vulvar cancer and scheduled to undergo SLN biopsy (patients with squamous cell carcinomas and melanomas will be included) * Primary tumor ≤4 cm in size * For patients with squamous cell carcinoma, \>1 mm of invasion is required Exclusion Criteria: * Clinically or radiographically enlarged inguinofemoral lymph nodes (if imaging is performed) * Presence of distant metastases * Absolute contraindication to radiocolloid Tc-99 or ICG * Nonsquamous or nonmelanoma histologic subtype

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Conditions

The condition(s) this trial relates to.

vulva cancer vulvar melanoma vulvar squamous cell carcinoma

As listed by the trial registrant

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

Vulvar cancer

Contacts and locations

Locations

  • Houston Methodist Cancer Center (Data Collection Only)

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604, United States

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