Intraoperative Fluorescence-Guided Lymphatic Mapping

The clinical trial was approved by the Institutional Review Board (IRB) of the Beth Israel Deaconess Medical Center and was performed in accordance with the ethical standards of the Helsinki Declaration of 1975. The IRB deemed the FLARE™ imaging system a “non-significant risk” device. All patients gave informed consent and were anonymized. Clinical trial participants were women undergoing SLN mapping for breast cancer. All subjects received the standard-of-care with injection, on average, of 834 µCi ^99mTc-sulfur colloid performed by the covering nuclear medicine physician approximately 2 hours prior to surgery. ^99mTc-sulfur colloid was administered as 4 deep peri-tumoral injections and 4 subcutaneous peri-tumoral injections of ≈ 0.2 cc each. In the operating room, a single surgeon (Dr. Troyan) injected a total of 1.6 ml of ICG:HSA, given as 4 deep peri-tumoral injections and 4 sub-cutaneous peri-tumoral injections of ≈ 0.2 cc each. The injection site was massaged for approximately 5 min. Lymphatic mapping using a handheld gamma probe was performed as per standard practice except that the 40,000 lux of white (400–650 nm) light illuminating the surgical field was provided by the FLARE™ imaging system, which was positioned 18” away from the patient. Settings included 14 mW/cm² of 760 nm NIR fluorescence excitation light, a 67 msec color video camera exposure time, and a 67 to 250 msec 800 nm NIR fluorescence camera exposure time.