Intraoperative Evaluation of Axillary Lymphatics

Overview

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 Title of Study: “Intraoperative Evaluation of Axillary Lymphatics for Breast Cancer Patients Undergoing Axillary Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2023

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=20) or axillary lymph node dissection (n=5) 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.

Interventions

  • Device: OnLume Imaging System
    • for fluorescence-guided surgery with ICG dye
  • Drug: Indocyanine green
    • Indocyanine green is a cyanine dye used in medical diagnostics

Arms, Groups and Cohorts

  • Experimental: Axillary Surgery
    • Breast cancer patients undergoing SLN biopsy (n=20) or axillary lymph node dissection (n=5) 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Maximum Contrast-to-Noise Ratio of ICG/OnLume Imaging System fluorescence signal
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Wisconsin, Madison
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Heather B Neuman, MD, MS, FACS, Principal Investigator, University of Wisconsin, Madison
  • Overall Contact(s)
    • Cancer Connect, 800-622-8922, clinicaltrials@cancer.wisc.edu

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