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ICG Sentinel Lymph Node Mapping for Breast Cancer
Phase < 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of operation
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
I have early-stage breast cancer and need a surgery to check my lymph nodes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day of operation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of operation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Accuracy of the ICG mapping
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.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,265 Total Patients Enrolled
938 Trials studying Breast Cancer
1,543,323 Patients Enrolled for Breast Cancer
University of Wisconsin, MadisonLead Sponsor
1,176 Previous Clinical Trials
3,011,941 Total Patients Enrolled
35 Trials studying Breast Cancer
38,509 Patients Enrolled for Breast Cancer
OnLume Inc.Industry Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled
1 Trials studying Breast Cancer
9 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand and give consent for treatment.You are allergic to indocyanine green.I have had surgery on the same side breast or underarm before.I have early-stage breast cancer and need a surgery to check my lymph nodes.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Sentinel Lymph Node (SLN) mapping
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research initiative available to participants at the present time?
"Correct. According to clinicaltrials.gov, the investigation was initiated on April 13th 2023 and continues to recruit participants who satisfy its inclusion criteria. 10 subjects must be enrolled from a single site for this trial to reach completion."
Answered by AI
How many individuals are engaged in this research project?
"Affirmative. Clinicaltrials.gov has evidence that recruitment for this project is ongoing, having been initially posted on April 13th of 2023 and recently updated on May 5th of the same year. 10 participants need to be enrolled at a single site."
Answered by AI
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