title: The FLARE intraoperative near-infrared fluorescence imaging system: a first-in-human clinical trial in breast cancer sentinel lymph node mapping.
abstract: BACKGROUND
  Invisible NIR fluorescent light can provide high sensitivity, high-resolution, and real-time image-guidance during oncologic surgery, but imaging systems that are presently available do not display this invisible light in the context of surgical anatomy. The FLARE imaging system overcomes this major obstacle.
  
  
  METHODS
  Color video was acquired simultaneously, and in real-time, along with two independent channels of NIR fluorescence. Grayscale NIR fluorescence images were converted to visible "pseudo-colors" and overlaid onto the color video image. Yorkshire pigs weighing 35 kg (n = 5) were used for final preclinical validation of the imaging system. A six-patient pilot study was conducted in women undergoing sentinel lymph node (SLN) mapping for breast cancer. Subjects received (99m)Tc-sulfur colloid lymphoscintigraphy. In addition, 12.5 microg of indocyanine green (ICG) diluted in human serum albumin (HSA) was used as an NIR fluorescent lymphatic tracer.
  
  
  RESULTS
  The FLARE system permitted facile positioning in the operating room. NIR light did not change the look of the surgical field. Simultaneous pan-lymphatic and SLN mapping was demonstrated in swine using clinically available NIR fluorophores and the dual NIR capabilities of the system. In the pilot clinical trial, a total of nine SLNs were identified by (99m)Tc- lymphoscintigraphy and nine SLNs were identified by NIR fluorescence, although results differed in two patients. No adverse events were encountered.
  
  
  CONCLUSIONS
  We describe the successful clinical translation of a new NIR fluorescence imaging system for image-guided oncologic surgery.
authors: Breast Care Center, Department of Surgery, Beth Israel Deaconess Medical Center, Boston, MA, USA.
authors: Susan L
authors: SL
authors: Troyan
authors: Vida
authors: V
authors: Kianzad
authors: Summer L
authors: SL
authors: Gibbs-Strauss
authors: Sylvain
authors: S
authors: Gioux
authors: Aya
authors: A
authors: Matsui
authors: Rafiou
authors: R
authors: Oketokoun
authors: Long
authors: L
authors: Ngo
authors: Ali
authors: A
authors: Khamene
authors: Fred
authors: F
authors: Azar
authors: John V
authors: JV
authors: Frangioni
mesh_terms: D000368:Aged; D000818:Animals; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000601:surgery; D004396:Coloring Agents; D005260:Female; D005453:Fluorescence; D005470:Fluorometry / Q000379:methods*; D006801:Humans; D007208:Indocyanine Green; D007432:Intraoperative Period; D008198:Lymph Nodes / Q000000981:diagnostic imaging / Q000473:pathology*; D008207:Lymphatic Metastasis; D008875:Middle Aged; D010865:Pilot Projects; D011877:Radionuclide Imaging; D019275:Radiopharmaceuticals; D021701:Sentinel Lymph Node Biopsy; D025321:Surgery, Computer-Assisted; D034421:Sus scrofa; D013671:Technetium Tc 99m Sulfur Colloid
chemical_list: D004396:Coloring Agents; D019275:Radiopharmaceuticals; D013671:Technetium Tc 99m Sulfur Colloid; D007208:Indocyanine Green