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Intraoperative Evaluation of Axillary Lymphatics
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
- Breast Cancer
- Lymphedema
- Surgery
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)
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
Find a Location
Who is running the clinical trial?
OnLume Inc.Industry Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,234 Previous Clinical Trials
3,200,282 Total Patients Enrolled
3 Trials studying Lymphedema
183 Patients Enrolled for Lymphedema
National Institutes of Health (NIH)NIH
2,826 Previous Clinical Trials
8,166,547 Total Patients Enrolled
2 Trials studying Lymphedema
313 Patients Enrolled for Lymphedema
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,161 Total Patients Enrolled
32 Trials studying Lymphedema
14,371 Patients Enrolled for Lymphedema
Heather B Neuman, MD, MS, FACSPrincipal InvestigatorUniversity of Wisconsin, Madison