ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study
1 other identifier
interventional
48
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 ovarian-cancer
Started Aug 2019
Longer than P75 for early_phase_1 ovarian-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2019
CompletedStudy Start
First participant enrolled
August 5, 2019
CompletedFirst Posted
Study publicly available on registry
August 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2025
CompletedDecember 17, 2025
December 1, 2025
6.3 years
August 5, 2019
December 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number and location of ovarian sentinel lymph nodes visually identified after injection of ICG dye via one of three tested methods.
Evaluate for dye uptake in the regional lymphatic channels, and in the pelvic and para-aortic nodes using infrared imaging.
1 year
Study Arms (4)
Group 1
EXPERIMENTALFirst group of 10 participants enrolled
Group 2
EXPERIMENTALSecond group of 10 participants enrolled
Group 3
EXPERIMENTALThird group of 10 participants enrolled
Group 4
EXPERIMENTALFourth group of 10 participants enrolled
Interventions
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
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ginger Gardner, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2019
First Posted
August 9, 2019
Study Start
August 5, 2019
Primary Completion
December 8, 2025
Study Completion
December 8, 2025
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.