title: The usefulness of a preoperative compact imager, a hand-held gamma-camera for breast cancer sentinel node biopsy: final results of a prospective double-blind, clinical study.
abstract: The aim of this study was to compare the effectiveness of a hand-held preoperative compact imager (POCI) camera with conventional lymphoscintigraphy using a γ-camera for sentinel lymph node (SLN) detection in breast cancer.
  
  
  METHODS
  The main objective was to demonstrate the noninferiority of the POCI relative to conventional lymphoscintigraphy and to compare the number of SLNs detected by the 2 imaging devices. Our study, a clinical prospective, double-blind, noninferiority study, planned to include 200 patients with early breast cancer and started in January 2006. A standard SLN protocol (4 periareolar injections of 37 MBq of (99m)Tc-nanocolloids, 2 h before lymphoscintigraphy) was performed preoperatively using a conventional γ-camera and then the POCI camera. Scans were obtained by 2 different nuclear medicine physicians unaware of each other's results. The day after, in the operating room, the surgeon, after receiving the previous results, used the counting probe for surgical SLN biopsy. The number and localization of axillary SLNs obtained by lymphoscintigraphy and the POCI and the duration of the whole procedure were determined.
  
  
  RESULTS
  Among the 162 patients included, 138 were evaluable. The POCI detected more SLNs than did lymphoscintigraphy in 50 patients (36%), the same number of in 54 patients (39%), and fewer SLNs in 34 patients (25%), representing 84 (61%) discordant pairs. The noninferiority of preoperative compact imaging of axillary SLNs numbers was found to be statistically significant (95% confidence interval, 30%-52%, P = 0.025) using the McNemar test. The duration of acquisition was shorter using the POCI (<10 min in 84% [n = 117] of patients; mean, 7.5 ± 3.3 min) than lymphoscintigraphy (13% [n = 18] of patients; mean, 15.7 ± 3.4 min), with P < 0.001 using the McNemar test for paired proportions.
  
  
  CONCLUSIONS
  Preoperative compact imaging using a hand-held camera was able to predict the number and localization of breast cancer SLNs and was not inferior to conventional lymphoscintigraphy in this study. Further studies will determine whether preoperative compact imaging could replace lymphoscintigraphy, especially in surgical centers without an on-site nuclear medicine department.
authors.affiliation: Nuclear Medicine Department, AP-HP Hôpital Tenon, Paris, France.
authors.forename: Khaldoun
authors.initials: K
authors.lastname: Kerrou
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Pitre
authors.forename: Charles
authors.initials: C
authors.lastname: Coutant
authors.forename: Roman
authors.initials: R
authors.lastname: Rouzier
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Ancel
authors.forename: Cécile
authors.initials: C
authors.lastname: Lebeaux
authors.forename: Virginie
authors.initials: V
authors.lastname: Huchet
authors.forename: Françoise
authors.initials: F
authors.lastname: Montravers
authors.forename: Odile
authors.initials: O
authors.lastname: Pascal
authors.forename: Marie-Alix
authors.initials: MA
authors.lastname: Duval
authors.forename: Françoise
authors.initials: F
authors.lastname: Lefebvre
authors.forename: Laurent
authors.initials: L
authors.lastname: Menard
authors.forename: Serge
authors.initials: S
authors.lastname: Uzan
authors.forename: Yves
authors.initials: Y
authors.lastname: Charon
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Barranger
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000465:Algorithms; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000601:surgery; D004311:Double-Blind Method; D005260:Female; D015902:Gamma Cameras; D006801:Humans; D008198:Lymph Nodes / Q000000981:diagnostic imaging; D008875:Middle Aged; D019095:Point-of-Care Systems; D057234:Preoperative Period; D011446:Prospective Studies; D011859:Radiography; D011877:Radionuclide Imaging; D019275:Radiopharmaceuticals; D018401:Sample Size; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*; D013668:Technetium Tc 99m Aggregated Albumin; D055815:Young Adult
chemical_list: D019275:Radiopharmaceuticals; D013668:Technetium Tc 99m Aggregated Albumin; C083602:technetium Tc 99m nanocolloid