Objective
In early cervical cancer, a total pelvic lymphadenectomy is the standard of care even though most patients have negative nodes and thus undergo lymphadenectomy unnecessarily. Although the value of sentinel lymph node mapping in early stage cervical cancer has not yet been established, near-infrared (NIR) fluorescence imaging is a promising technique to perform this procedure. NIR fluorescence imaging is based on invisible NIR light and can provide high sensitivity, high-resolution, and real-time image-guidance during surgery.
Methods/materials
Clinical trial subjects were 9 consecutive cervical cancer patients undergoing total pelvic lymphadenectomy. Prior to surgery, 1.6 mL of indocyanine green adsorbed to human serum albumin (ICG:HSA) was injected transvaginally and submucosally in 4 quadrants around the tumor. Patients were allocated to 500, 750, or 1,000 μM ICG:HSA concentration groups. The Mini-FLARE™ imaging system was used for NIR fluorescence detection and quantitation.
Results
Sentinel lymph nodes were identified in all 9 patients. An average of 3.4 ± 1.2 sentinel lymph nodes was identified per patient. No differences in signal to background of the sentinel lymph nodes between the 500, 750, and 1,000 μM dose groups were found (P = 0.73). In 2 patients, tumor-positive lymph nodes were found. In both patients, tumor-positive lymph nodes confirmed by pathology were also NIR fluorescent.
Conclusions
This study demonstrated preliminary feasibility to successfully detect sentinel lymph nodes in cervical cancer patients using ICG:HSA and the Mini-FLARE™ imaging system. When considering safety, cost-effectiveness, and pharmacy preferences, an ICG:HSA concentration of 500 μM was optimal for sentinel lymph node mapping in cervical cancer patients.