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ICG Sentinel Lymph Node Mapping for Breast Cancer

Phase < 1
Waitlist Available
Led By Heather Neuman, MD
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
≥ 18 years of age
Diagnosis of clinical T1 or T2 breast cancer clinically node negative breast cancer requiring surgical lymph node evaluation
Must not have
Unable to provide informed consent
History of ipsilateral breast or axillary surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of operation
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a new imaging device and dye can accurately locate sentinel lymph nodes to help diagnose and treat breast cancer.

Who is the study for?
This trial is for adults over 18 with early-stage breast cancer (T1 or T2) who need lymph node evaluation and are having surgery at the University of Wisconsin Hospital and Clinic. It's not for those pregnant, breastfeeding, allergic to indocyanine green dye, unable to consent, or with previous surgery in the same breast or armpit area.
What is being tested?
The study is testing a new method for sentinel lymph node biopsy using a dye called indocyanine green (ICG) and an imaging device named Asimov Platform. This will be compared to the standard practice using technetium-99m and possibly blue dye.
What are the potential side effects?
Potential side effects may include allergic reactions to ICG dye such as rash, hives, difficulty breathing; however these are generally rare. The procedure itself carries typical surgical risks like infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have early-stage breast cancer and need a surgery to check my lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand and give consent for treatment.
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I have had surgery on the same side breast or underarm before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of operation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Lymph Node Level
Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Patient Level
Secondary study objectives
Accuracy of the ICG Mapping

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: Sentinel Lymph Node (SLN) mappingExperimental Treatment2 Interventions
SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SLN mapping using technetium-99m +/- isosulfan blue dye
2023
Completed Early Phase 1
~10
SLN mapping with ICG fluorescence using the Asimov Platform
2023
Completed Early Phase 1
~10

Find a Location

Who is running the clinical trial?

OnLume Inc.Industry Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled
1 Trials studying Breast Cancer
9 Patients Enrolled for Breast Cancer
University of Wisconsin, MadisonLead Sponsor
1,227 Previous Clinical Trials
3,198,453 Total Patients Enrolled
35 Trials studying Breast Cancer
38,471 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,916 Previous Clinical Trials
41,011,835 Total Patients Enrolled
941 Trials studying Breast Cancer
1,443,245 Patients Enrolled for Breast Cancer

Media Library

Asimov Platform Clinical Trial Eligibility Overview. Trial Name: NCT05859971 — Phase < 1
Breast Cancer Research Study Groups: Sentinel Lymph Node (SLN) mapping
Breast Cancer Clinical Trial 2023: Asimov Platform Highlights & Side Effects. Trial Name: NCT05859971 — Phase < 1
Asimov Platform 2023 Treatment Timeline for Medical Study. Trial Name: NCT05859971 — Phase < 1
~4 spots leftby Nov 2025
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