Breast Cancer Clinical Trial
Intraoperative Evaluation of Axillary Lymphatics
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.
Full 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.
Eligibility Criteria
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
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There is 1 Location for this study
Madison Wisconsin, 53792, United States More Info
Principal Investigator
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