ICG and SLN Mapping

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

April 13, 2023

Primary Completion Date

June 1, 2023

Study Completion Date

June 1, 2023

Conditions
Breast Cancer
Interventions
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.

Trial Locations (1)

53705

University of Wisconsin, Madison

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

OnLume Inc.

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

University of Wisconsin, Madison

OTHER