Intraoperative Evaluation of Axillary Lymphatics

University of Wisconsin (UW)

Status: Completed

Conditions: Breast Cancer; Surgery; Lymphedema

Treatments: Device: OnLume Imaging System; Drug: Indocyanine green

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05094102

SMPH/SURGERY/SURG ONC (Other Identifier)

Protocol Version 11/3/2022 (Other Identifier)

2R44CA206754-02A1 (U.S. NIH Grant/Contract)

A539713 (Other Identifier)

UW20058

2020-0939 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Axillary Surgery

Experimental group

Description:

Breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) 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.

Treatment:

Drug: Indocyanine green

Device: OnLume Imaging System