Intraoperative Evaluation of Axillary Lymphatics

Study Overview
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Brief Summary
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This study will assess the feasibility of using the OnLume Imaging System for fluorescence-guided surgery along with indocyanine green (ICG) dye in the operating room for the axillary reverse mapping (ARM) procedure in women with breast cancer scheduled to have axillary dissection (AD) or sentinel lymph node (SLN) biopsy.

Detailed Description
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Lymphatic drainage from the upper arm is often different from that of the breast, allowing safe removal of only the lymphatics of the breast and protection of the lymphatic channels draining the upper extremity during axillary dissection (AD) or sentinel lymph node (SLN) biopsy, thereby reducing the risk of arm lymphedema. In this prospective study, breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification. The standard of care (blue dye) will be used for clinical care while the OnLume Imaging System is being used to determine feasibility of the product.

Official Title
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Intraoperative Evaluation of Axillary Lymphatics for Breast Cancer Patients Undergoing Axillary Surgery

Conditions
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Lymphedema, Surgery, Breast Cancer

Intervention / Treatment
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* Device: OnLume Imaging System
* Drug: Indocyanine green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Diagnosis of breast cancer requiring surgical lymph node evaluation either by sentinel lymph node biopsy or axillary lymph node dissection Surgery at University of Wisconsin Hospital and Clinic Exclusion Criteria: Pregnant or breast feeding Unable to provide informed consent Allergy to indocyanine green Patients with clinically positive lymph nodes undergoing sentinel lymph node biopsy, with or without axillary lymph node dissection, after neoadjuvant chemotherapy

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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Axillary Surgery<br>Breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo standard of care axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification. | Device: OnLume Imaging System<br>* for fluorescence-guided surgery with ICG dye<br>Drug: Indocyanine green<br>* Indocyanine green is a cyanine dye used in medical diagnostics<br>* Other names: ICG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cases where lymphatics were visualized by blue dye versus by ICG using the OnLume Imaging System | This measure will determine whether lymphatics were visualized (yes/no) by each modality during axillary reverse mapping | up to 1 day (day of surgery) | 
| Number of cases where lymphatics were spared by blue dye versus by ICG using the OnLume Imaging System | This measure will determine whether lymphatics were spared (yes/no) by each modality during axillary reverse mapping | up to 1 day (day of surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Contrast-to-Noise Ratio of ICG/OnLume Imaging System fluorescence signal | A time curve of contrast-to-noise (CNR) ratio of lymphatic vessels to background tissue will be measured over the time frame of up to five minutes post-injection. The fluorescence signal intensity in both (1) the lymphatic vessels and in (2) the surrounding tissue will be measured in fluorescence arbitrary units. These two values will be aggregated to calculate and report the CNR, which is a unitless ratio. The maximum CNR will be reported. | Imaging data will be collected on the day of surgery (Day 1) - CNR will be measured up to five minutes post-injection of ICG] |