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NCT Number: NCT05094102

Intraoperative Evaluation of Axillary Lymphatics

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.

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Key information

Conditions

Lymphedema Breast Cancer Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Surgery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OnLume Imaging System

Device

for fluorescence-guided surgery with ICG dye

Indocyanine green

Drug

Indocyanine green is a cyanine dye used in medical diagnostics

Other names: ICG

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
  • OnLume Inc.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2021
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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