IRB Study Number 16-477
Status Recruiting
Phase Not Applicable
Location Fairview Hospital
Institute Dermatology and Plastic Surgery Institute
Description
We invite you to take part in a research study because you are undergoing a sentinel lymph node biopsy. The purpose of this study is to determine if the integrated imaging goggle (Smart Goggles) is as good as or better than current technology used to identify the sentinel lymph node (SLN) in using the indocyanine green dye.
In this pilot study, we are testing the feasibility of a new device, the Integrated Imaging Goggle system (also called “Smart Goggles”) as a surgical aid to identify the axillary sentinel lymph node(s) by comparing measurements of ICG fluorescently-tagged lymph nodes with current fluorescent imaging technology. As a starting point to test the capabilities of the Smart Goggles and to optimize its technical settings, we will focus on SLN in breast cancer. In this study, researchers will test how quickly and accurately the ICG fluorescent dye used to identify the lymph node(s) is detected by Smart Goggles.
Inclusion Criteria
Female subjects with at least 1 lesion of tumor of the breast, undergoing a sentinel lymph node biopsy as part of standard of care procedure
Subjects must have the ability to understand and the willingness to sign a written informed consent document.
At least age 18 or older.
Exclusion Criteria
The presence of any of the following will exclude a subject from study enrollment.
Subjects who have been treated with radiation therapy on the chest.
Has had previous sentinel lymph node biopsy
Has a known hypersensitivity to ICG, methylene blue and 99mTc-colloid.
