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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2021

Interventions

  • Drug: Method 1: Indocyanine green dye
    • 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
  • Drug: Method 2: Indocyanine green dye
    • 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
  • Drug: Method 3: Indocyanine green dye
    • Injection of 4mL 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

Arms, Groups and Cohorts

  • Group 1
    • First group of 10 participants enrolled
  • Group 2
    • Second group of 10 participants enrolled
  • Group 3
    • Third group of 10 participants enrolled

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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 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

  • Prior bilateral oophorectomy
  • Known severe anaphylactic iodide allergy
  • Known history of cirrhosis or other chronic liver disease, or women with hepatic dysfunction as evidenced by elevated transaminases

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ginger Gardner, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
  • Overall Contact(s)
    • Ginger Gardner, MD, 212-639-2375, gardnerg@mskcc.org

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