ICG and SLN Mapping

University of Wisconsin (UW)

Status and phase: Completed; Early Phase 1

Conditions: Breast Cancer

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

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05859971

SMPH/SURGERY/SURG ONC (Other Identifier)

Protocol Version 11/29/2022 (Other Identifier)

2023-0030

UW22145 (Other Identifier)

5R44CA206754 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Sentinel Lymph Node (SLN) mapping

Experimental group

Description:

SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging.

Treatment:

Device: SLN mapping with ICG fluorescence using the Asimov Platform

Drug: SLN mapping using technetium-99m +/- isosulfan blue dye