title: Prospective randomized clinical trial comparing intradermal, intraparenchymal, and subareolar injection routes for sentinel lymph node mapping and biopsy in breast cancer.
abstract: BACKGROUND
  Multiple injection routes, including intradermal (ID), intraparenchymal (IP), and subareolar (SA), are used for 99mTc-sulfur colloid administration for sentinel lymph node (SLN) mapping and biopsy in breast cancer. The aim of this study was to compare localization by ID, IP, and SA injection routes based on preoperative lymphoscintigraphy and intraoperative identification.
  
  
  METHODS
  Four hundred prospectively randomized breast cancers underwent SLN mapping and biopsy.
  
  
  RESULTS
  Preoperative lymphoscintigraphy demonstrated localization to the axilla in 126/133 (95%) ID, 82/132 (62%) IP, and 96/133 (72%) SA (P < 0.001 ID vs. IP and ID vs. SA; P = 0.081 IP vs. SA), with a mean duration of preoperative lymphoscintigraphy of 139 +/- 18 minutes. Mean time to first localization when localization was demonstrated on preoperative lymphoscintigraphy was 8 +/- 14 minutes for ID, 53 +/- 49 for IP, and 22 +/- 29 for SA (P < 0.001 ID vs. IP and ID vs. SA; P = 0.003 IP vs. SA). Intraoperative identification of a SLN at the time of SLN biopsy was successful in 133/133 (100%) ID, 121/134 (90%) IP, and 126/133 (95%) SA (P < 0.001 ID vs IP; P = 0.014 ID vs. SA; P = 0.168 IP vs. SA), with a mean time from injection of 99mTc-sulfur colloid to start of SLN biopsy of 288 +/- 71 minutes. Mean intraoperative time to harvest the first SLN was 9 +/- 4 minutes for ID, 13 +/- 6 for IP, and 12 +/- 6 for SA (P < 0.001 ID vs. IP and ID vs. SA; P = 0.410 IP vs. SA).
  
  
  CONCLUSIONS
  The ID injection route demonstrated a significantly greater frequency of localization, decreased time to first localization on preoperative lymphoscintigraphy, and decreased time to harvest the first SLN. This represents the first prospective randomized clinical trial to confirm superiority of the ID route for administration of 99mTc-sulfur colloid during SLN mapping and biopsy in breast cancer.
authors.affiliation: Section of Surgical Oncology, Department of Surgery, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute and Comprehensive Cancer Center, The Ohio State University, Columbus, OH, 43210, USA. stephen.povoski@osumc.edu
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Povoski
authors.forename: Johannes O
authors.initials: JO
authors.lastname: Olsen
authors.forename: Donn C
authors.initials: DC
authors.lastname: Young
authors.forename: Johannah
authors.initials: J
authors.lastname: Clarke
authors.forename: William E
authors.initials: WE
authors.lastname: Burak
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Walker
authors.forename: William E
authors.initials: WE
authors.lastname: Carson
authors.forename: Lisa D
authors.initials: LD
authors.lastname: Yee
authors.forename: Doreen M
authors.initials: DM
authors.lastname: Agnese
authors.forename: Rodney V
authors.initials: RV
authors.lastname: Pozderac
authors.forename: Nathan C
authors.initials: NC
authors.lastname: Hall
authors.forename: William B
authors.initials: WB
authors.lastname: Farrar
mesh_terms: D001943:Breast Neoplasms / Q000473:pathology*; D004333:Drug Administration Routes; D005260:Female; D006801:Humans; D007271:Injections, Intradermal; D015552:Injections, Intralesional; D008198:Lymph Nodes / Q000473:pathology*; D008207:Lymphatic Metastasis; D008220:Lymphography; D008875:Middle Aged; D011300:Preoperative Care; D011446:Prospective Studies; D019275:Radiopharmaceuticals; D021701:Sentinel Lymph Node Biopsy / Q000379:methods; D013671:Technetium Tc 99m Sulfur Colloid
chemical_list: D019275:Radiopharmaceuticals; D013671:Technetium Tc 99m Sulfur Colloid