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Completed

NCT Number: NCT04051502

ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study

The purpose of this study is to find out how well ovarian sentinel lymph nodes (SLNs) can be identified with indocyanine green (ICG) dye during risk-reducing ovarian surgery.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Memorial Sloan Kettering Basking Ridge (Consent only), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Method 1: Indocyanine green dye

Drug

Injection 4 mL of ICG dye directly into the fallopian tube (1 or more places is acceptable) only to the side where the adnexal mass is located

Other names: ICG dye

Method 2: Indocyanine green dye

Drug

1mL of ICG injected at each of the four sites: only to the side where the adnexal mass is located

  • Dorsal side of the IP ligament
  • Ventral side of the IP ligament
  • Dorsal side of the utero-ovarian ligament
  • Ventral side of the utero-ovarian ligament

Other names: ICG dye

Method 3: Indocyanine green dye

Drug

Injection of 2mL of ICG dye into the IP ligament pedicle after the adnexal mass has been removed. Only to the side where the adnexal mass is located

Other names: ICG dye

Primary outcomes

  1. Number and location of ovarian sentinel lymph nodes visually identified after injection of ICG dye via one of three tested methods.

    Time frame: 1 year

    Evaluate for dye uptake in the regional lymphatic channels, and in the pelvic and para-aortic nodes using infrared imaging.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2019
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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