ICG and SLN Mapping

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI); OnLume Inc.

Criteria

Inclusion Criteria:

• ≥ 18 years of age

• Diagnosis of clinical T1 or T2 breast cancer clinically node negative breast cancer requiring surgical lymph node evaluation

• Surgery at University of Wisconsin Hospital and Clinic

Exclusion Criteria:

• Pregnant: It is not known whether indocyanine green can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Women of child-bearing age will undergo a urine pregnancy test on the day of surgery, which is standard of care prior to anesthesia.

• Breastfeeding: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when indocyanine green is administered to a nursing woman. We will exclude women who are breastfeeding.

• Unable to provide informed consent

• Allergy to indocyanine green

• History of ipsilateral breast or axillary surgery