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OnLume Imaging System for Truncal Lymphedema

N/A

Waitlist Available

Led By Heather B Neuman, MD, MS, FACS

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 day (day of surgery)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special camera system with a glowing dye to help surgeons better identify lymph nodes in women with breast cancer. The goal is to reduce the risk of arm swelling after surgery by clearly seeing and avoiding important lymphatic channels.

Eligible Conditions

Truncal Lymphedema
Breast Cancer
Surgery
Lymphedema

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 day (day of surgery)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 day (day of surgery)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 day (day of surgery) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

Maximum Contrast-to-Noise Ratio of ICG/OnLume Imaging System Fluorescence Signal

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Axillary SurgeryExperimental Treatment2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

OnLume Imaging System

2022

N/A

~10

Indocyanine green

2016

Completed Phase 4

~1720