← Back to Search

OnLume Imaging System for Breast Cancer

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

Study Summary

This trial will test if a new imaging system can help surgeons better find and remove cancerous lymph nodes in women with breast cancer.

Eligible Conditions
  • Breast Cancer
  • Surgery
  • Lymphedema

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Maximum Contrast-to-Noise Ratio of ICG/OnLume Imaging System fluorescence signal

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
1 Trials studying Breast Cancer
10 Patients Enrolled for Breast Cancer
University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,378 Total Patients Enrolled
35 Trials studying Breast Cancer
38,510 Patients Enrolled for Breast Cancer
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,570 Total Patients Enrolled
49 Trials studying Breast Cancer
110,776 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applicants currently being welcomed to participate in this experiment?

"Affirmative. Clinicaltrials.gov records attest to this clinical trial's recruitment status, which began on May 5th 2022 and was last amended on June 29th 2022. The researchers are hoping to find 25 patients at a single medical facility."

Answered by AI

How many people are currently engaged in this medical experiment?

"Affirmative. The information on clinicaltrials.gov asserts that this research project, which was originally shared online on May 5th 2022, is actively seeking participants. A total of 25 volunteers are needed to be recruited from one particular medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intraoperative Evaluation of Axillary Lymphatics
2022. "Intraoperative Evaluation of Axillary Lymphatics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05094102.
~3 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top