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

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


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.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Coloring Agents / chemistry
  • Diagnostic Imaging / methods
  • Double-Blind Method
  • Female
  • Fluorescent Dyes / chemistry
  • Humans
  • Indocyanine Green* / chemistry
  • Infrared Rays
  • Intraoperative Care / methods
  • Lymph Nodes / pathology*
  • Lymphatic Metastasis
  • Microscopy, Fluorescence / methods*
  • Middle Aged
  • Neoplasm Staging
  • Sentinel Lymph Node Biopsy / methods*
  • Serum Albumin / chemistry
  • Spectroscopy, Near-Infrared / methods*
  • Uterine Cervical Neoplasms / diagnosis
  • Uterine Cervical Neoplasms / pathology*
  • Uterine Cervical Neoplasms / surgery


  • Coloring Agents
  • Fluorescent Dyes
  • Serum Albumin
  • Indocyanine Green