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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ovarian Cancer, Adnexal Mass

Intervention / Treatment
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* Drug: Method 1: Indocyanine green dye
* Drug: Method 2: Indocyanine green dye
* Drug: Method 3: Indocyanine green dye
* Drug: Method 3: Indocyanine green dye


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>First group of 10 participants enrolled | Drug: Method 1: Indocyanine green dye<br>* 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<br>* Other names: ICG dye;|
| Group 2<br>Second group of 10 participants enrolled | Drug: Method 2: Indocyanine green dye<br>* 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<br>* Other names: ICG dye;|
| Group 3<br>Third group of 10 participants enrolled | Drug: Method 3: Indocyanine green dye<br>* 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<br>* Other names: ICG dye;|
| Group 4<br>Fourth group of 10 participants enrolled | Drug: Method 3: Indocyanine green dye<br>* Injection of 2mL of ICG dye into the IP ligament pedicle before the adnexal mass is removed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and location of ovarian sentinel lymph nodes visually identified after injection of ICG dye via one of three tested methods. | Evaluate for dye uptake in the regional lymphatic channels, and in the pelvic and para-aortic nodes using infrared imaging. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Cancer, Adnexal Mass, Ovarian Sentinal Lymph Nodes, 19-271, Memorial Sloan Kettering Cancer Center, Sentinal Lymph Nodes, indocyanine green dye, ICG Dye