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NCT04051502 Clinical Trial

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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04051502
Other study ID # 19-271
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 5, 2019
Est. completion date August 2024

Study information
Verified date February 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 48
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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
• 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
• 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
• Method 3: Indocyanine green dye
Injection of 2mL of ICG dye into the IP ligament pedicle before the adnexal mass is removed.

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Consent only) Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack (Consent only) Commack New York
United States Memorial Sloan Kettering Westchester (Consent only) Harrison New York
United States Memorial Sloan Kettering Monmouth (Consent only) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Consent only ) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau (Consent only) Uniondale New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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