Status:
COMPLETED
ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Ovarian Cancer
Adnexal Mass
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04051502
Start Date
August 5 2019
End Date
December 8 2025
Last Update
December 17 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, United States, 11725