title: Randomized comparison of near-infrared fluorescence imaging using indocyanine green and 99(m) technetium with or without patent blue for the sentinel lymph node procedure in breast cancer patients.
abstract: BACKGROUND
  Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has the potential to improve sentinel lymph node (SLN) mapping of breast cancer. We performed a randomized clinical trial to assess the value of blue dyes when used in combination with NIR fluorescence. We also preliminarily examined the possibility of performing SLN mapping without radiotracers.
  
  
  METHODS
  Clinical trial subjects were 24 consecutive breast cancer patients scheduled to undergo SLN biopsy. All patients received standard of care using 99(m) technetium-nanocolloid and received 1.6 mL of 500 μM ICG injected periareolarly. Patients were randomly assigned to undergo SLN biopsy with or without patent blue. To assess the need for radiocolloids to localize the SLN or SLNs, the surgeon did not use the handheld gamma probe during the first 15 min after the axillary skin incision.
  
  
  RESULTS
  SLN mapping was successful in 23 of the 24 patients. No significant difference was found in signal-to-background ratio between the groups with and without patent blue (8.3 ± 3.8 vs. 10.3 ± 5.7, respectively, P = 0.32). In both groups, 100 % of SLNs were radioactive and fluorescent, and in the patent blue group, only 84 % of SLNs were stained blue. In 25 % of patients, the use of the gamma probe was necessary to localize the SLN within the first 15 min.
  
  
  CONCLUSIONS
  This study shows that there is no benefit of using patent blue for SLN mapping in breast cancer patients when using NIR fluorescence and 99(m) technetium-nanocolloid. NIR fluorescence imaging outperformed patent blue in all patients.
authors: Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
authors: Joost R
authors: JR
authors: van der Vorst
authors: Boudewijn E
authors: BE
authors: Schaafsma
authors: Floris P R
authors: FP
authors: Verbeek
authors: Merlijn
authors: M
authors: Hutteman
authors: J Sven D
authors: JS
authors: Mieog
authors: Clemens W G M
authors: CW
authors: Lowik
authors: Gerrit-Jan
authors: GJ
authors: Liefers
authors: John V
authors: JV
authors: Frangioni
authors: Cornelis J H
authors: CJ
authors: van de Velde
authors: Alexander L
authors: AL
authors: Vahrmeijer
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D018275:Carcinoma, Lobular / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D004396:Coloring Agents; D005260:Female; D005453:Fluorescence; D005500:Follow-Up Studies; D006801:Humans; D007091:Image Processing, Computer-Assisted; D007208:Indocyanine Green; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009367:Neoplasm Staging; D015609:Organotechnetium Compounds; D011379:Prognosis; D011877:Radionuclide Imaging; D019275:Radiopharmaceuticals; D012394:Rosaniline Dyes; D021701:Sentinel Lymph Node Biopsy; D019265:Spectroscopy, Near-Infrared
chemical_list: D004396:Coloring Agents; D015609:Organotechnetium Compounds; D019275:Radiopharmaceuticals; D012394:Rosaniline Dyes; C008769:sulfan blue; D007208:Indocyanine Green