N/A
N=9
Intraoperative Evaluation of Axillary Lymphatics
Lymphedema · Surgery · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05094102 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Number of Cases Where Lymphatics Were Visualized by Blue Dye Versus by ICG Using the OnLume Imaging System — 5; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OnLume Imaging System (Device); Indocyanine green (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Cases Where Lymphatics Were Visualized by Blue Dye Versus by ICG Using the OnLume Imaging System |
5; 9 | — |
| PRIMARY Number of Cases Where Lymphatics Were Spared by Blue Dye Versus by ICG Using the OnLume Imaging System |
1; 5 | — |
| SECONDARY Maximum Contrast-to-Noise Ratio of ICG/OnLume Imaging System Fluorescence Signal |
54.9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05094102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.