Clinical trial NCT04051502: ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study
Official title: ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Ovarian Cancer
Adnexal Mass
Keywords: Ovarian Cancer
Adnexal Mass
Ovarian Sentinal Lymph Nodes
19-271
Memorial Sloan Kettering Cancer Center
Sentinal Lymph Nodes
indocyanine green dye
ICG Dye
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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 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.

Primary outcomes:
measure: Number and location of ovarian sentinel lymph nodes visually identified after injection of ICG dye via one of three tested methods.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only )
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Ginger Gardner, MD
role: PRINCIPAL_INVESTIGATOR
References: