ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study
NCT ID: NCT04051502
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
48 participants
INTERVENTIONAL
2019-08-05
2025-12-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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Group 1
First group of 10 participants enrolled
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
Group 2
Second group of 10 participants enrolled
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
Group 3
Third group of 10 participants enrolled
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
Group 4
Fourth group of 10 participants enrolled
Method 3: Indocyanine green dye
Injection of 2mL of ICG dye into the IP ligament pedicle before the adnexal mass is removed.
Interventions
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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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ginger Gardner, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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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
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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19-271
Identifier Type: -
Identifier Source: org_study_id