ICG and SLN Mapping

Early Phase 1

Completed

Interventions: Drug: SLN mapping using technetium-99m +/- isosulfan blue dye
Device: SLN mapping with ICG fluorescence using the Asimov Platform

Brief 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.

Detailed Description: In this study, the sentinel lymph node biopsy will be performed with radioactive tracer (technetium-99 sulfur colloid) and blue dye, which is standard of care. Decisions will be made during surgery about which lymph nodes to remove using information from the radioactive tracer and blue dye alone.

For this research, ICG fluorescence dye during participant's surgery will also be used. After anesthesia has started, the ICG fluorescence dye will be injected in the breast along at the edge of the areola in the same location as the radioactive tracer and blue dye injections. The breast and axilla will then be imaged with the Asimov Imaging Platform to look for the sentinel lymph nodes.

Recruitment & Eligibility

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. Study team will exclude women who are breastfeeding.
Unable to provide informed consent
Allergy to indocyanine green
History of ipsilateral breast or axillary surgery

Arm && Interventions

Group	Intervention	Description
Sentinel Lymph Node (SLN) mapping	SLN mapping using technetium-99m +/- isosulfan blue dye	SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging.
Sentinel Lymph Node (SLN) mapping	SLN mapping with ICG fluorescence using the Asimov Platform	SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging.

Primary Outcome Measures

Name	Time	Method
Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Lymph Node Level	Day of operation	The study team will describe concordance rates between technetium-99 and ICG-fluorescence for each sentinel lymph node removed.
Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Patient Level	Day of operation	The study team will assess concordance rates at the patient level rates between technetium-99 and ICG-fluorescence.

Secondary Outcome Measures

Name	Time	Method
Accuracy of the ICG Mapping	Day of operation	Using the technetium-99as the gold standard, the study team will describe the number of lymph nodes that would have been missed (i.e. technetium-99 + but ICG- in removed SLN) or would have been excised unnecessarily (i.e. residual ICG-fluorescence in axilla but no residual technetium-99) if ICG-fluorescent imaging had guided the SLN.