ICG Sentinel Lymph Node Mapping for Breast Cancer

Palo Alto (17 mi)

Overseen byHeather Neuman, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Wisconsin, Madison

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this research study is to assess the feasibility of using a different dye and imaging device, indocyanine green (ICG)-fluorescent imaging through the Asimov Imaging Platform, to perform sentinel lymph node biopsy. Participants in this research study will be undergoing a sentinel lymph node biopsy as part of surgical treatment for breast cancer. Active participation will last through the post-operative visit.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I have early-stage breast cancer and need a surgery to check my lymph nodes.

Exclusion Criteria

I am unable to understand and give consent for treatment.

I have had surgery on the same side breast or underarm before.

Treatment Details

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.

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.