Randomized comparison of near-infrared fluorescence lymphatic tracers for sentinel lymph node mapping of cervical cancer.
OBJECTIVE
Near-infrared fluorescence imaging using indocyanine green (ICG) has recently been introduced as a novel technique for sentinel lymph node (SLN) mapping in early-stage cervical cancer. Although preclinical research has shown that ICG adsorbed to human serum albumin (ICG:HSA) improves its performance, the need for HSA has not yet been confirmed in cervical cancer patients. The current randomized study aims to determine whether ICG:HSA offers advantages over using ICG alone.


METHODS
Eighteen consecutive early-stage cervical cancer patients scheduled to undergo pelvic lymphadenectomy were included. Prior to surgery, 1.6 mL of 500 μM ICG:HSA or 500 μM ICG alone was injected transvaginally in 4 quadrants around the tumor. The Mini-FLARE imaging system was used for intraoperative NIR fluorescence detection and quantitation.


RESULTS
SLNs were identified intraoperatively in 78% of the patients. Patient and tumor characteristics were equally distributed over both treatment groups. No significant difference in signal-to-background ratio (9.3 vs. 10.1, P=.72) or average number of detected SLNs (2.9 vs 2.7, P=.84) was found between the ICG:HSA group and the ICG alone group, respectively.


CONCLUSIONS
In conclusion, this double-blind, randomized trial showed no advantage of ICG:HSA over ICG alone for the SLN procedure in early-stage cervical cancer. Further optimization is required to improve the intraoperative detection rate.
Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Boudewijn E
BE
Schaafsma
Joost R
JR
van der Vorst
Katja N
KN
Gaarenstroom
Alexander A W
AA
Peters
Floris P R
FP
Verbeek
Cornelis D
CD
de Kroon
J Baptist M Z
JB
Trimbos
Mariette I E
MI
van Poelgeest
John V
JV
Frangioni
Cornelis J H
CJ
van de Velde
Alexander L
AL
Vahrmeijer
D000328:Adult; D000368:Aged; D004396:Coloring Agents / Q000737:chemistry; D003952:Diagnostic Imaging / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D005456:Fluorescent Dyes / Q000737:chemistry; D006801:Humans; D007208:Indocyanine Green / Q000737:chemistry; D007259:Infrared Rays; D007430:Intraoperative Care / Q000379:methods; D008198:Lymph Nodes / Q000473:pathology*; D008207:Lymphatic Metastasis; D008856:Microscopy, Fluorescence / Q000379:methods*; D008875:Middle Aged; D009367:Neoplasm Staging; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*; D012709:Serum Albumin / Q000737:chemistry; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000473:pathology* / Q000601:surgery
D004396:Coloring Agents; D005456:Fluorescent Dyes; D012709:Serum Albumin; D007208:Indocyanine Green