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 undergopelvic lymphadenectomy were included. Prior to surgery, 1.6 mL of 500 μMICG:HSA or 500 μMICG 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.
RCT Entities:
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 humanserum albumin (ICG:HSA) improves its performance, the need for HSA has not yet been confirmed in cervical cancerpatients. The current randomized study aims to determine whether ICG:HSA offers advantages over using ICG alone. METHODS: Eighteen consecutive early-stage cervical cancerpatients 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.
Authors: Merlijn Hutteman; J Sven D Mieog; Joost R van der Vorst; Gerrit Jan Liefers; Hein Putter; Clemens W G M Löwik; John V Frangioni; Cornelis J H van de Velde; Alexander L Vahrmeijer Journal: Breast Cancer Res Treat Date: 2011-03-01 Impact factor: 4.872
Authors: Shunsuke Ohnishi; Stephen J Lomnes; Rita G Laurence; Andrew Gogbashian; Giuliano Mariani; John V Frangioni Journal: Mol Imaging Date: 2005 Jul-Sep Impact factor: 4.488
Authors: John P Diaz; Mary L Gemignani; Neeta Pandit-Taskar; Kay J Park; Melissa P Murray; Dennis S Chi; Yukio Sonoda; Richard R Barakat; Nadeem R Abu-Rustum Journal: Gynecol Oncol Date: 2011-01-08 Impact factor: 5.482
Authors: L Gortzak-Uzan; W Jimenez; S Nofech-Mozes; N Ismiil; M A Khalifa; V Dubé; B Rosen; J Murphy; S Laframboise; A Covens Journal: Gynecol Oncol Date: 2009-10-28 Impact factor: 5.482
Authors: Alexander L Vahrmeijer; Merlijn Hutteman; Joost R van der Vorst; Cornelis J H van de Velde; John V Frangioni Journal: Nat Rev Clin Oncol Date: 2013-07-23 Impact factor: 66.675
Authors: Ray R Zhang; Alexandra B Schroeder; Joseph J Grudzinski; Eben L Rosenthal; Jason M Warram; Anatoly N Pinchuk; Kevin W Eliceiri; John S Kuo; Jamey P Weichert Journal: Nat Rev Clin Oncol Date: 2017-01-17 Impact factor: 66.675
Authors: B E Schaafsma; F P R Verbeek; A A W Peters; J R van der Vorst; C D de Kroon; M I E van Poelgeest; J B M Z Trimbos; C J H van de Velde; J V Frangioni; A L Vahrmeijer; K N Gaarenstroom Journal: BJOG Date: 2013-02-19 Impact factor: 6.531
Authors: Hideyuki Wada; Hoon Hyun; Christina Vargas; Elizabeth M Genega; Julien Gravier; Sylvain Gioux; John V Frangioni; Hak Soo Choi Journal: Ann Surg Oncol Date: 2015-05-13 Impact factor: 5.344
Authors: Jason M Warram; Esther de Boer; Lindsay S Moore; Cecelia E Schmalbach; Kirk P Withrow; William R Carroll; Joshua S Richman; Anthony B Morlandt; Margaret Brandwein-Gensler; Eben L Rosenthal Journal: J Surg Oncol Date: 2015-06-12 Impact factor: 3.454