Intraoperative Evaluation of Axillary Lymphatics

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05094102
• Collaborator: National Institutes of Health (NIH) (NIH), OnLume Inc. (Industry), National Cancer Institute (NCI) (NIH)
• Enrollment: 25
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 9.9
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphedema; Surgery; Breast Cancer	Device: OnLume Imaging System; Drug: Indocyanine green	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intraoperative Evaluation of Axillary Lymphatics for Breast Cancer Patients Undergoing Axillary Surgery
• Actual Study Start Date: May 5, 2022
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Axillary Surgery 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.	Device: OnLume Imaging System; for fluorescence-guided surgery with ICG dye; Drug: Indocyanine green; Indocyanine green is a cyanine dye used in medical diagnostics; Other Names: ICG

Outcome Measures

Primary Outcome Measures

1. Number of cases where lymphatics were visualized by blue dye versus by ICG using the OnLume Imaging System [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 [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 Outcome Measures

1. Maximum Contrast-to-Noise Ratio of ICG/OnLume Imaging System fluorescence signal [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• University of Wisconsin, Madison
• National Institutes of Health (NIH)
• OnLume Inc.
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Heather B Neuman, MD, MS, FACS, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT05094102
• Other Study ID Numbers: UW20058; 2020-0939; A539713; SMPH/SURGERY/SURG ONC; Protocol Version 6/6/2022; 2R44CA206754-02A1
• First Posted: Oct 26, 2021
• Last Update Posted: Jul 5, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Breast Neoplasms; Lymphedema

Study Results

No Results Posted as of Jul 5, 2022