Prospective multicentric randomized study comparing periareolar and peritumoral injection of radiotracer and blue dye for the detection of sentinel lymph node in breast sparing procedures: FRANSENODE trial.
OBJECTIVE
To determine the optimal injection path for blue dye and radiocolloid for sentinel lymph node (SLN) biopsy in early breast cancer.


METHODS
A prospective randomized multicentric study was initiated to compare the peritumoral (PT) injection site to the periareolar (PA) site in 449 patients.


RESULTS
The detection rate of axillary SLN by lymphoscintigraphy was significantly higher (P = .03) in the PA group (85.2%) than in the PT group (73.2%). Intraoperative detection rate by blue dye and/or gamma probe was similar (99.11%) in both groups. The rate of SLN detection was somewhat higher in the PA group than in the PT group: 95.6% versus 93.8% with blue dye (P = .24) and 98.2% versus 96.0% by probe (P = .16), respectively. The number of SLNs detected by lymphoscintigraphy and by probe was significantly higher in the PA group than in the PT group, 1.5 versus 1.2 (P = .001) and 1.9 versus 1.7 (P = .02). The blue and hot concordance was 95.6% in the PA group and 91.5% in the PT group (P = .08). The mean ex vivo count of the SLN was significantly higher in the PA group than in the PT group (P < .0001).


CONCLUSIONS
This study strongly validates the PA injection technique given the high detection rate (99.1%) of SLN and the high concordance (95.6%) between blue dye and the radiotracer, as well as higher significant ex and in vivo counts, improving SLN probe detection.
Rodier
Jean-François
JF
French Comprehensive Cancer Centers of Strasbourg, Toulouse, Lyon, Nantes, Bordeaux, Marseille, France. jrodier@strasbourg.fnclcc.fr
Velten
Michel
M
Wilt
Marc
M
Martel
Pierre
P
Ferron
Gwanaël
G
Vaini-Elies
Véronique
V
Mignotte
Hervé
H
Brémond
Alain
A
Classe
Jean-Marc
JM
Dravet
François
F
Routiot
Thierry
T
de Lara
Christine Tunon
CT
Avril
Antoine
A
Lorimier
Gérard
G
Fondrinier
Eric
E
Houvenaeghel
Gilles
G
Avigdor
Sandrine
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001365:Axilla; D004396:Coloring Agents / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007267:Injections; D007432:Intraoperative Period; D008198:Lymph Nodes / Q000000981:diagnostic imaging; D015412:Mastectomy, Segmental; D008875:Middle Aged; D011877:Radionuclide Imaging; D019275:Radiopharmaceuticals / Q000008:administration & dosage*; D012394:Rosaniline Dyes / Q000008:administration & dosage*; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*; D013671:Technetium Tc 99m Sulfur Colloid / Q000008:administration & dosage*
D004396:Coloring Agents; D019275:Radiopharmaceuticals; D012394:Rosaniline Dyes; C512413:nanocis; D013671:Technetium Tc 99m Sulfur Colloid; C008769:sulfan blue