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

Completed · Early Phase 1

Conditions studied: Ovarian Cancer, Adnexal Mass

In brief

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.

Key facts

Study ID

NCT04051502

Run by

Memorial Sloan Kettering Cancer Center

People needed

48

Starts

2019-08-05

Expected to finish

2025-12-08

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Memorial Sloan Kettering Basking Ridge (Consent only) — Basking Ridge, New Jersey, 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 Commack (Consent only) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Consent only) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau (Consent only) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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