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

Memorial Sloan Kettering Cancer Center (MSK)

Status

Active, not recruiting

Conditions

Ovarian Cancer

Adnexal Mass

Treatments

Drug: Method 3: Indocyanine green dye

Drug: Method 2: Indocyanine green dye

Drug: Method 1: Indocyanine green dye

Study type

Observational

Funder types

Other

Identifiers

NCT04051502

19-271

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.