title: Comparison of sentinel lymph node biopsy guided by the multimodal method of indocyanine green fluorescence, radioisotope, and blue dye versus the radioisotope method in breast cancer: a randomized controlled trial.
abstract: OBJECTIVE
  This study aimed to evaluate the identification rate and surgery time of sentinel lymph node biopsy (SLNB) by a multimodal method (MMM) using a mixture of indocyanine green (ICG), radioisotope (RI), and blue dye (BD) compared with the RI alone.
  
  
  METHODS
  In this phase II randomized study, 86 patients with clinically node-negative breast cancer were enrolled and received SLNB with either MMM or RI. We compared the identification rate, number of sentinel lymph nodes (SLNs), and detection time of SLNB and evaluated the safety.
  
  
  RESULTS
  The mean age of the MMM group and RI group was 48.2 and 51.0 years (p = 0.12), respectively. There were no differences in histopathologic factors, including tumor size, node positivity, and hormone receptor positivity between groups. SLNs were identified in all patients of both groups (100 % in the MMM group and 100 % in the RI group). The average number of SLNs in the MMM group was more than that in the RI group (3.4 ± 1.37 vs. 2.3 ± 1.04, respectively; p < 0.001). The time to detect the first sentinel lymph node was similar in each group (6.5 ± 5.16 vs. 8.0 ± 4.35 min; p = 0.13). In the MMM group, percutaneous lymphatic drainage was visualized by fluorescent imaging in 90.7 % (39 of 43 patients). During and after the operation, there were no complications, including allergic reactions, skin staining, or necrosis.
  
  
  CONCLUSIONS
  This study is the first randomized trial that compared MMM using ICG, RI, and BD and the conventional RI method for SLNB. MMM is a feasible and safe method for SLNB.
authors.affiliation: Center for Breast Cancer, National Cancer Center, Goyang, Gyeonggi, Republic of Korea, goje1@medimail.co.kr.
authors.forename: So-Youn
authors.initials: SY
authors.lastname: Jung
authors.forename: Seok-Ki
authors.initials: SK
authors.lastname: Kim
authors.forename: Seok Won
authors.initials: SW
authors.lastname: Kim
authors.forename: Youngmee
authors.initials: Y
authors.lastname: Kwon
authors.forename: Eun Sook
authors.initials: ES
authors.lastname: Lee
authors.forename: Han-Sung
authors.initials: HS
authors.lastname: Kang
authors.forename: Kyoung Lan
authors.initials: KL
authors.lastname: Ko
authors.forename: Kyung Hwan
authors.initials: KH
authors.lastname: Shin
authors.forename: Keun Seok
authors.initials: KS
authors.lastname: Lee
authors.forename: In Hae
authors.initials: IH
authors.lastname: Park
authors.forename: Jungsil
authors.initials: J
authors.lastname: Ro
authors.forename: Hae Jeong
authors.initials: HJ
authors.lastname: Jeong
authors.forename: Jungnam
authors.initials: J
authors.lastname: Joo
authors.forename: Se Hun
authors.initials: SH
authors.lastname: Kang
authors.forename: Seeyoun
authors.initials: S
authors.lastname: Lee
mesh_terms: D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology* / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D018275:Carcinoma, Lobular / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D004396:Coloring Agents; D005260:Female; D005456:Fluorescent Dyes; D005500:Follow-Up Studies; D006801:Humans; D007208:Indocyanine Green; D008198:Lymph Nodes / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D008207:Lymphatic Metastasis; D008875:Middle Aged; D064847:Multimodal Imaging; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D011379:Prognosis; D011877:Radionuclide Imaging; D019275:Radiopharmaceuticals; D021701:Sentinel Lymph Node Biopsy; D017556:Technetium Compounds; D017971:Tin Compounds
chemical_list: D004396:Coloring Agents; D005456:Fluorescent Dyes; D019275:Radiopharmaceuticals; D017556:Technetium Compounds; D017971:Tin Compounds; C033493:technetium Tc 99m tin colloid; D007208:Indocyanine Green