NCT05094102

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

May 5, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 23, 2024

Completed
Last Updated

November 13, 2024

Status Verified

October 1, 2024

Enrollment Period

12 months

First QC Date

September 8, 2021

Results QC Date

April 25, 2024

Last Update Submit

October 23, 2024

Conditions

LymphedemaSurgeryBreast Cancer

Outcome Measures

Primary Outcomes (2)

  • Number of Cases Where Lymphatics Were Visualized by Blue Dye Versus by ICG Using the OnLume Imaging System

    This measure will determine whether lymphatics were visualized (yes/no) by each modality during axillary reverse mapping

    up to 1 day (day of surgery)

  • Number of Cases Where Lymphatics Were Spared by Blue Dye Versus by ICG Using the OnLume Imaging System

    This measure will determine whether lymphatics were spared (yes/no) by each modality during axillary reverse mapping

    up to 1 day (day of surgery)

Secondary Outcomes (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]

Study Arms (1)

Axillary Surgery

EXPERIMENTAL

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 SystemDrug: Indocyanine green

Interventions

OnLume Imaging SystemDEVICE

for fluorescence-guided surgery with ICG dye

Axillary Surgery
Indocyanine greenDRUG

Indocyanine green is a cyanine dye used in medical diagnostics

Also known as: ICG
Axillary Surgery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

LymphedemaBreast Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Heather Neuman, MD, MS
Organization
University of Wisconsin School of Medicine and Public Health
neuman@surgery.wisc.edu
(608) 262-2025

Study Officials

  • Heather B Neuman, MD, MS, FACS

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2021

First Posted

October 26, 2021

Study Start

May 5, 2022

Primary Completion

April 27, 2023

Study Completion

April 27, 2023

Last Updated

November 13, 2024

Results First Posted

May 23, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)