At a glance
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Use of ICG-fluorescent Imaging for Sentinel Lymph Node Mapping in Patients With Breast Cancer
In Brief
A Early Phase 1 clinical trial evaluating SLN mapping using technetium-99m +/- isosulfan blue dye and SLN mapping with ICG fluorescence using the Asimov Platform for Breast Cancer. Completed, enrolled 10 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.