Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine if Indocyanine Green (IC-GREEN) is comparable to isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes during nodal staging procedures in breast cancer.

Detailed Description
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It is the objective of the current study to test Indocyanine Green (IC-GREEN) as an agent for mapping arm draining lymphatics and nodes and compare it to isosulfan blue (IS-BLUE) in the setting of sentinel node procedures with or without axillary node dissections in women with breast cancer. All participants will also have tumor samples evaluated with 99technetium-sulfur colloid, a radiolabel used to identify tumor markers.

Official Title
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A Pilot Study to Assess the Utility of Indocyanine Green™ (IC-GREEN™) SPY Imaging in the Mapping of Arm Draining Lymphatics and Nodes During Sentinel Node Resection With or Without Axillary Dissection in Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: SPY Elite Imaging
* Drug: Indocyanine Green
* Drug: Isosulfan blue
* Drug: 99technetium-sulfur colloid radiolabel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent document. Signed written informed consent. Women undergoing sentinel lymph node biopsy. Women with breast cancer with known or suspected lymph node involvement. Women undergoing sentinel node identification and completion axillary lymph node dissection. Women of 18 years of age or older. Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Status 0,1,2. Complete Blood Count (CBC) and basic Metabolic Panel within 6 months Exclusion Criteria: History of liver or kidney failure will not be eligible. Allergies to iodine containing products will not be eligible. Women who are pregnant will not be eligible. Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ISB and ICG<br>The dose of Isosulfan blue (ISB) dye and Indocyanine green (ICG) solution will be started. (IC-GREEN) SPY Elite Imaging willbe used to capture the images of axillary cavity. | Device: SPY Elite Imaging<br>* A camera that is directed into the axillary cavity to try to capture an image of the tumor site labeled with Indocyanine green before and after excising sentinel nodes<br>Drug: Indocyanine Green<br>* started at 1mg /mL If fluorescence is not detected with this dose, then it will be increased by 50%.<br>* Other names: ICG;Drug: Isosulfan blue<br>* 3 to 5 mL If fluorescence is not detected with this dose, then it will be increased by 50%.<br>* Other names: Lymphazurin;Drug: 99technetium-sulfur colloid radiolabel<br> <br> * Other names: 99tech;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN) | Number of women with agreement of the two dies [ie, isosulfan blue (IS-BLUE) and indocyanine green (IC-GREEN)] on all nodes examined in the lymphatics and arm-draining lymph nodes, during nodal staging procedures for surgery to treat breast cancer with curative intent. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes | The outcome is expressed as the number of participants whose resected sentinel lymph nodes (SLN) bound 99technetium-sulfur colloid (99tech), a tumor marker radiolabel; Indocyanine Green (IC-GREEN; GREEN), a fluorescent label; or isosulfan blue (IS-BLUE; BLUE), a visual dye. Results are expressed as: Any HOT = Those whose samples bound 99tech. Not HOT = Those whose samples did not bind 99tech. Not HOT (also no BLUE, no GREEN) = Those whose samples did not bind 99tech; and also did not bind IC-GREEN nor IS-BLUE. HOT, BLUE, GREEN = Those whose samples bound all of 99tech; IC-GREEN; and IS-BLUE. HOT, no BLUE, no GREEN = Those whose samples bound 99tech, but did not bind either of IC-GREEN nor IS-BLUE. HOT, GREEN only, no BLUE = Those whose samples bound 99tech and IC-GREEN, but did not bind IS-BLUE. | 1 day |