• Boudewijn E Schaafsma, Joost R van der Vorst, Katja N Gaarenstroom, Alexander A W Peters, Floris P R Verbeek, Cornelis D de Kroon, J Baptist M Z Trimbos, Mariette I E van Poelgeest, John V Frangioni, Cornelis J H van de Velde, and Alexander L Vahrmeijer.
• Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
• Gynecol. Oncol. 2012 Oct 1; 127 (1): 126-30.

ObjectiveNear-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.MethodsEighteen 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.ResultsSLNs 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.ConclusionsIn 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.Copyright © 2012 Elsevier Inc. All rights reserved.

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