The NIR light source of our device is based on light-emitting diodes (LEDs), which can
deliver sufficient light to biological tissues and induce fluorescence emission to meet the
needs of the planned clinical studies. It should be noted that the light source is still
well under the US FDA recommended limit for NIR exposure and ANSI standard. In addition, the
light source is not laser-based, which is significantly safer than other optical imaging
systems utilizing laser technologies. The fluorescence signals will be received by the
detector portion of our device. Gain-settings could be easily adjusted during operation to
optimize the contrast between high fluorescence areas (tumors) and low fluorescence areas
(normal tissues). Real-time fluorescence video will be displayed in the goggle eyepiece as
well as on a secondary monitor to facilitate viewing by other surgeons in the room.
- Newly diagnosed with clinically node-negative breast cancer or melanoma being staged
with SLN biopsy.
- Negative nodal basin clinical exam.
- At least 18 years of age.
- Able to understand and willing to sign a written informed consent document.
- Contraindications for surgery.
- Receiving any investigational agents.
- History of allergic reactions attributed to ICG or other agents used in the study,
including known iodide or seafood allergy.
- Presence of uncontrolled intercurrent illness including, but not limited to, ongoing
or active infection of the breast and/or axilla, symptomatic congestive heart
failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements.
- Breastfeeding. Patients who are breastfeeding are excluded from this study because
there is an unknown but potential risk for adverse events in nursing infants
secondary to treatment of the mother with ICG dye.