We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04051502
Recruitment Status : Active, not recruiting
First Posted : August 9, 2019
Last Update Posted : February 2, 2023
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Ovarian Cancer Adnexal Mass Drug: Method 1: Indocyanine green dye Drug: Method 2: Indocyanine green dye Drug: Method 3: Indocyanine green dye

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: 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 Name: ICG dye
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 before the adnexal mass is removed.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051502


Locations
Layout table for location information
United States, New Jersey
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States, 07920
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, United States, 07645
United States, New York
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, United States, 11553
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Ginger Gardner, MD Memorial Sloan Kettering Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04051502    
Other Study ID Numbers: 19-271
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Ovarian Cancer
Adnexal Mass
Ovarian Sentinal Lymph Nodes
19-271
 Memorial Sloan Kettering Cancer Center
Sentinal Lymph Nodes
indocyanine green dye
ICG Dye
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
 Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders