Intraoperative Evaluation of Axillary Lymphatics

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Axillary Surgery	OnLume Imaging System	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.
Axillary Surgery	Indocyanine green	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.

Primary Outcome Measures

Name	Time	Method
Number of Cases Where Lymphatics Were Spared by Blue Dye Versus by ICG Using the OnLume Imaging System	up to 1 day (day of surgery)	This measure will determine whether lymphatics were spared (yes/no) by each modality during axillary reverse mapping
Number of Cases Where Lymphatics Were Visualized by Blue Dye Versus by ICG Using the OnLume Imaging System	up to 1 day (day of surgery)	This measure will determine whether lymphatics were visualized (yes/no) by each modality during axillary reverse mapping

Secondary Outcome Measures

Name	Time	Method
Maximum Contrast-to-Noise Ratio of ICG/OnLume Imaging System Fluorescence Signal	Imaging data will be collected on the day of surgery (Day 1) - CNR will be measured up to five minutes post-injection of ICG]	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.

Locations (1): University of Wisconsin School of Medicine and Public Health
🇺🇸
Madison, Wisconsin, United States