Intraoperative Evaluation of Axillary Lymphatics

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH); OnLume Inc.

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