title: An extended phase II trial of iodine-125 methylene blue for sentinel lymph node identification in women with breast cancer.
abstract: BACKGROUND
  The aim of this study was to determine if an intraoperative injection of iodine-125-labeled methylene blue ((125)I-MB) is a sensitive and effective method for detecting SLNs in women with breast cancer.
  
  
  METHODS
  Sixty-two women were enrolled in an extended phase II trial using (125)I-MB to guide SLNB. All patients were anesthetized and then injected subcutaneously with 1 mCi (125)I-MB in the outer quadrant of the areola.
  
  
  RESULTS
  Radioactivity was detected in the axilla within 3 to 5 minutes. Fifty-eight of 62 (94%) patients had SLNs detected during their procedure. Mean (±SD) number of SLNs per patient was 1.8 ± 1.3 (range 0 to 6). A total of 112 nodes were dissected from 58 women; 110 of these nodes were considered sentinel. One hundred and eight (98%) nodes were hot, 98 (89%) nodes were blue, and 96 (87%) nodes were both hot and blue. Two women had complications; 1 had superficial skin staining and 1 had a superficial skin slough. Both healed uneventfully. No allergic reactions were observed. No radioactive uptake in the thyroid was seen.
  
  
  CONCLUSIONS
  Iodine-125-labeled methylene blue can be mixed and administered in the operating room, improving hospital efficiency. Patient satisfaction is higher with (125)I-MB than with the technetium 99m sulfur colloid procedure because (125)I-MB does not produce localized burning and other adverse reactions associated with the traditional method, and 125I-MB is administered with the patient under anesthesia. Iodine-125 emits a lower-energy gamma ray than technetium 99m, lowering the surgeon's radiation exposure. Iodine-125-labeled methylene blue SLN identification is safe, cost effective, and produces equivalent outcomes compared with the traditional technique, making it an attractive alternative.
authors.affiliation: Louisiana State University Health Sciences Center, University Medical Center, Lafayette, LA, USA.
authors.forename: William W
authors.initials: WW
authors.lastname: Harkrider
authors.forename: Anne E
authors.initials: AE
authors.lastname: Diebold
authors.forename: Thomas
authors.initials: T
authors.lastname: Maloney
authors.forename: Gregory
authors.initials: G
authors.lastname: Espenan
authors.forename: Yi-Zarn
authors.initials: YZ
authors.lastname: Wang
authors.forename: Shawn J
authors.initials: SJ
authors.lastname: Stafford
authors.forename: Arthur
authors.initials: A
authors.lastname: Camp
authors.forename: Daniel
authors.initials: D
authors.lastname: Frey
authors.forename: Charles
authors.initials: C
authors.lastname: Chappuis
authors.forename: Eugene A
authors.initials: EA
authors.lastname: Woltering
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology*; D005260:Female; D006801:Humans; D007267:Injections; D007430:Intraoperative Care; D007457:Iodine Radioisotopes / Q000008:administration & dosage; D008751:Methylene Blue / Q000008:administration & dosage; D008875:Middle Aged; D011877:Radionuclide Imaging; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*
chemical_list: D007457:Iodine Radioisotopes; D008751:Methylene Blue