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

February 1, 2024 updated by: Memorial Sloan Kettering Cancer Center
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge (Consent only)
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth (Consent only)
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen (Consent only )
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack (Consent only)
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester (Consent only)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau (Consent only)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited from the Gynecology Service, Department of Surgery. All women undergoing surgery for an adnexal mass, with or without a hysterectomy, without clear preoperative suspicion for advanced stage ovarian disease will be screened for participation in this study. No selectivity will be exercised by the investigators as to minimize bias. The specific type of surgery, as well as its timing, will be determined by the treating gynecologic surgeon

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
First group of 10 participants enrolled
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
Other Names:
  • ICG dye
Group 2
Second group of 10 participants enrolled
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
Other Names:
  • ICG dye
Group 3
Third group of 10 participants enrolled
Drug: Method 3: Indocyanine green dye
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
Drug: Method 3: Indocyanine green dye
Injection of 2mL of ICG dye into the IP ligament pedicle before the adnexal mass is removed.
Group 4
Fourth group of 10 participants enrolled
Drug: Method 3: Indocyanine green dye
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
Drug: Method 3: Indocyanine green dye
Injection of 2mL of ICG dye into the IP ligament pedicle before the adnexal mass is removed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Ginger Gardner, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2019

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

August 5, 2019

First Submitted That Met QC Criteria

August 7, 2019

First Posted (Actual)

August 9, 2019

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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