Clinical trial NCT05094102: Intraoperative Evaluation of Axillary Lymphatics
Official title: Intraoperative Evaluation of Axillary Lymphatics for Breast Cancer Patients Undergoing Axillary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Surgery
Breast Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: OnLume Inc.
name: National Cancer Institute (NCI)
First posted: 2021-10-26
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Cases Where Lymphatics Were Visualized by Blue Dye Versus by ICG Using the OnLume Imaging System
timeFrame: up to 1 day (day of surgery)
measure: Number of Cases Where Lymphatics Were Spared by Blue Dye Versus by ICG Using the OnLume Imaging System
timeFrame: up to 1 day (day of surgery)
Secondary outcomes:
measure: Maximum Contrast-to-Noise Ratio of ICG/OnLume Imaging System Fluorescence Signal
timeFrame: Imaging data will be collected on the day of surgery (Day 1) - CNR will be measured up to five minutes post-injection of ICG]
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Heather B Neuman, MD, MS, FACS
role: PRINCIPAL_INVESTIGATOR
References: