Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma

Study Overview
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Brief Summary
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The NIR light source of our device is based on light-emitting diodes (LEDs), which can deliver sufficient light to biological tissues and induce fluorescence emission to meet the needs of the planned clinical studies. It should be noted that the light source is still well under the US FDA recommended limit for NIR exposure and ANSI standard. In addition, the light source is not laser-based, which is significantly safer than other optical imaging systems utilizing laser technologies. The fluorescence signals will be received by the detector portion of our device. Gain-settings could be easily adjusted during operation to optimize the contrast between high fluorescence areas (tumors) and low fluorescence areas (normal tissues). Real-time fluorescence video will be displayed in the goggle eyepiece as well as on a secondary monitor to facilitate viewing by other surgeons in the room.

Official Title
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Evaluation of Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma

Conditions
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Breast Cancer, Cancer of Breast, Cancer of the Breast, Melanoma, Malignant Melanoma

Intervention / Treatment
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* Procedure: Sentinel lymph node biopsy
* Device: Goggle-based device with light-emitting diodes (LED)
* Drug: Indocynanine Green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed with clinically node-negative breast cancer or melanoma being staged with SLN biopsy. Negative nodal basin clinical exam. At least 18 years of age. Able to understand and willing to sign a written informed consent document. Exclusion Criteria: Contraindications for surgery. Receiving any investigational agents. History of allergic reactions attributed to ICG or other agents used in the study, including known iodide or seafood allergy. Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the breast and/or axilla, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant. Breastfeeding. Patients who are breastfeeding are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ICG dye.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: SLN biopsy with ICG injection<br>During the SLN biopsy, the patient will undergo injection of ICG around the breast tumor or melanoma per standard techniques. 1.6 mL of 500 micro-molar ICG will be injected periareolarly (for breast cancer) or peri-tumorly (for melanoma). This will be performed after standard of care technetium-colloid injection. Patients will then undergo the standard SLN biopsy procedure. After gamma-probe identification of the SLN, the surgeon will put on the goggle system to attempt to identify the SLN using fluorescence guidance. After this is performed, the goggle system will be removed and the SLN biopsy will be completed per standard techniques. Findings with the goggles will be recorded but will not change how the SLN biopsy is performed. | Procedure: Sentinel lymph node biopsy<br> <br> * Other names: SLN biopsy;Device: Goggle-based device with light-emitting diodes (LED)<br> <br> Drug: Indocynanine Green<br>* This is a infrared fluorescence imaging contrast agent<br>* Other names: ICG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability for the imaging device to identify the sentinel lymph node (SLN) during the SLN biopsy procedure compared to standard of care gamma-probe identification of the SLN | After gamma-probe identification of the SLN, the physician will put on the goggle system to attempt to identify the SLN using fluorescence guidance. After this is performed, the goggle system will be removed and the SLN biopsy will be completed per standard techniques. Findings with the goggles will be recorded but will not change how the SLN biopsy is performed. The surgically-removed SLNs will be pathologically examined under standard protocols. Identification of the SLN via fluorescence imaging will be compared to identification of the SLN via standard radiocolloid. Fluorescence imaging results will be classified in relation to the true status based on the standard SLN biopsy. Descriptive statistics will be utilized to describe the feasibility of the imaging modality in identifying the SLN. The main data point collected is Do ICG-identified node (s) have extra-corporeal gamma activity? | At the time of the biopsy procedure (approximately 1.5 hours) |