NCT05859971

ICG and SLN Mapping

Use of ICG-fluorescent Imaging for Sentinel Lymph Node Mapping in Patients With Breast Cancer

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	SLN mapping using technetium-99m +/- isosulfan blue dye	The isosulfan blue dye injection will be performed by the participating surgeon in the operating room; as per standard of care, injection will be subareolar. Incisions will be planned based on the technetium-99m activity or at the lateral aspect of the pectoralis muscle, per usual care.
DEVICE	SLN mapping with ICG fluorescence using the Asimov Platform	2 ml (5 mg) of ICG solution will be injected intradermally in 1-4 injection sites in the lateral areolar region. After injection, gentle manual massage will be performed for 5 minutes. ICG imaging will be obtained prior to incision. After incision is made (following standard of care procedures), the axilla will be visualized using the Asimov Platform to assess for ICG-fluorescence in sentinel lymph nodes.

Timeline

• Start date: 2023-04-13
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2023-05-16
• Last updated: 2025-07-29
• Results posted: 2024-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study