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Randomized Controlled Trial
. 2012 Oct;127(1):126-30.
doi: 10.1016/j.ygyno.2012.07.002. Epub 2012 Jul 10.

Randomized comparison of near-infrared fluorescence lymphatic tracers for sentinel lymph node mapping of cervical cancer

Boudewijn E Schaafsma  1 , 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, Alexander L Vahrmeijer
Affiliations
Randomized Controlled Trial

Randomized comparison of near-infrared fluorescence lymphatic tracers for sentinel lymph node mapping of cervical cancer

Boudewijn E Schaafsma et al. Gynecol Oncol. 2012 Oct.

Abstract

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.

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Conflict of interest statement

CONFLICT OF INTEREST

Boudewijn E. Schaafsma, M.D.: None

Joost R. van der Vorst, M.D.: None.

Katja N. Gaarenstroom, M.D., Ph.D.: None

Alexander A.W. Peters, M.D., Ph.D.: None

Floris P.R. Verbeek: None

Cornelis D. de Kroon, M.D., Ph.D.: None

J. Baptist M.Z. Trimbos, M.D., Ph.D.: None

Mariette I. E. van Poelgeest, M.D., Ph.D.: None

John V. Frangioni, M.D., Ph.D.: Mini-FLARE technology is owned by Beth Israel Deaconess Medical Center, a teaching hospital of Harvard Medical School. As inventor, Dr. Frangioni may someday receive royalties if products are commercialized. Dr. Frangioni is the founder and unpaid director of The FLARE Foundation, a non-profit organization focused on promoting the dissemination of medical imaging technology for research and clinical use.

Cornelis J.H. van de Velde, M.D., Ph.D.: None

Alexander L. Vahrmeijer, M.D., Ph.D.: None

Figures

Figure 1
Figure 1. NIR Fluorescence-Based SLN Mapping using ICG:HSA and Mini-FLARE
Identification of a SLN (arrow), located along the right iliac vessels, with NIR fluorescence imaging is demonstrated in a cervical cancer patient after administration of 500 μM ICG:HSA.
See this image and copyright information in PMC

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