title: The Value of Isosulfan Blue Dye in Addition to Isotope Scanning in the Identification of the Sentinel Lymph Node in Breast Cancer Patients With a Positive Lymphoscintigraphy: A Randomized Controlled Trial (ISRCTN98849733).
abstract: BACKGROUND
  Sentinel lymph node biopsy (SLNB) has become the gold standard for axillary staging. Debate remains as to the optimal method of SLN detection.
  
  
  OBJECTIVE
  Determine whether patients undergoing an SLNB required the addition of isosulfan blue dye to radioisotope when an SLN was identified on a preoperative lymphoscintigram.
  
  
  METHODS
  A prospective randomized controlled trial comparing the combination of radioisotope and blue dye versus radioisotope alone was performed between March 2010 and September 2012. The trial protocol was registered with Current Controlled Trials. Women with clinically and radiologically node-negative breast cancer with a positive preoperative lymphoscintigram were eligible for inclusion.
  
  
  RESULTS
  A total of 667 patients were included in the analysis with 342 patients receiving the combination (blue dye and radioisotope) and 325 patients receiving radioisotope alone. The groups were evenly matched both demographically and pathologically. The mean age was 48 years (48.3 vs 47.7 years; P = 0.47), the mean tumour size was 24.2 mm (24.3 mm vs 24.1 mm; P = 0.7) and there was no statistically significant difference in the grade of the tumors between the 2 groups (P = 0.58). There was no difference in the identification rate, nor was that in the number of nodes retrieved between the 2 groups (P = 0.30). There was no difference in the number of positive lymph nodes that were identified between the 2 groups (23.8% vs 22.1%; P = 0.64).
  
  
  CONCLUSIONS
  This study failed to demonstrate an advantage with the addition of isosulfan blue dye to radioisotope in the identification of the SLN in the presence of a positive preoperative lymphoscintigram.
authors.affiliation: Department of *Surgery, St Vincent's Healthcare Group, Elm Park, Dublin 4, Ireland †School of Mathematical Sciences, University College Dublin, Dublin 4, Ireland; and Departments of ‡Radiology, and §Pathology, St Vincent's Healthcare Group, Elm Park, Dublin 4, Ireland.
authors.forename: Elma Anna
authors.initials: EA
authors.lastname: OʼReilly
authors.forename: Ruth S
authors.initials: RS
authors.lastname: Prichard
authors.forename: Dhafir
authors.initials: D
authors.lastname: Al Azawi
authors.forename: Nitin
authors.initials: N
authors.lastname: Aucharaz
authors.forename: Gabrielle
authors.initials: G
authors.lastname: Kelly
authors.forename: Denis
authors.initials: D
authors.lastname: Evoy
authors.forename: James
authors.initials: J
authors.lastname: Geraghty
authors.forename: Jane
authors.initials: J
authors.lastname: Rothwell
authors.forename: Ann
authors.initials: A
authors.lastname: OʼDoherty
authors.forename: Cecily
authors.initials: C
authors.lastname: Quinn
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Skehan
authors.forename: Enda W
authors.initials: EW
authors.lastname: McDermott
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology* / Q000628:therapy; D004396:Coloring Agents; D005260:Female; D006801:Humans; D061305:Lymphoscintigraphy; D008408:Mastectomy; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D019275:Radiopharmaceuticals; D012394:Rosaniline Dyes; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*; D013670:Sodium Pertechnetate Tc 99m
chemical_list: D004396:Coloring Agents; D019275:Radiopharmaceuticals; D012394:Rosaniline Dyes; C025484:iso-sulfan blue; D013670:Sodium Pertechnetate Tc 99m