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Dye test aims to improve ovarian cancer staging

NCT ID NCT04051502

Knowledge-focused Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested if a special dye (ICG) can help surgeons find the first lymph nodes that ovarian cancer might spread to. 48 women having ovary surgery took part. The goal was to see if the dye works well for this purpose, which could help doctors better understand and stage the disease.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

48 people

The number who actually took part.

Started

Aug 2019

Finished

Dec 2025

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: * Women undergoing surgery with the Gynecology Service at MSK. * Women undergoing surgery for an adnexal mass without pre-operative suspicion of high stage disease, with or without a hysterectomy °For this protocol, "suspected high stage disease" will be defined as any patient with radiologic or clinical evidence of ovarian cancer which has spread outside of the ovary. Thus, only patients with an adnexal mass, or bilateral adnexal masses, are eligible. * Women in whom MIS surgery is converted to a laparotomy will not be excluded as both surgical approaches, MIS and open, will be utilized. * Women \>/= 18 years of age * Able to provide informed consent * Albumin levels within normal range Exclusion Criteria: * Current non-GYN primary malignancy * Prior or current history of uterine, cervical, peritoneal, or vulvovaginal malignancy * Ongoing anticancer therapy * Prior bilateral oophorectomy * Known severe anaphylactic iodide allergy * Known history of cirrhosis or other chronic liver disease, or women with hepatic dysfunction. * Elevated transaminases (ALT, AST) and/or Alk Phos will be evaluated by the treating physician on a case by case basis.

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Conditions

The condition(s) this trial relates to.

ovarian cancer

As listed by the trial registrant

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

Adnexal mass Ovarian cancer

Contacts and locations

Locations

  • Memorial Sloan Kettering Basking Ridge (Consent only)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (Consent only )

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack (Consent only)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (Consent only)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Consent only)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester (Consent only)

    Harrison, New York, 10604, United States

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