A prospective pilot study of detection of sentinel lymph nodes in gynaecological cancers using a novel near infrared fluorescence imaging system

Abstract

BackgroundSentinel Lymph Node (SLN) sampling may significantly reduce surgical morbidity by avoiding needless radical lymphadenectomy. In gynaecological cancers, the current practice in the UK is testing the accuracy of SLN detection using radioactive isotopes within the context of clinical trials. However, radioactive tracers pose significant logistic problems. We, therefore, conducted a pilot, observational study to assess the feasibility of a novel optical imaging device for SLN detection in gynaecological cancers using near infrared (NIR) fluorescence.MethodsA novel, custom-made, optical imaging system was developed to enable detection of multiple fluorescence dyes and allow simultaneous bright-field imaging during open surgery and laparoscopic procedures. We then evaluated the performance of the system in a prospective study of 49 women with early stage vulval, cervical and endometrial cancer who were scheduled to undergo complete lymphadenectomy. Clinically approved fluorescent contrast agents indocyanine green (ICG) and methylene blue (MB) were used. The main outcomes of the study included SLN mapping detection rates, false negative rates using the NIR fluorescence technique and safety of the procedures. We also examined the association between injection sites and differential lymphatic drainage in women with endometrial cancer by fluorescence imaging of ICG and MB.ResultsA total of 64 SLNs were detected during both open surgery and laparoscopy. Following dose optimisation and the learning phase, SLN detection rate approached 100 % for all cancer types with no false negatives detected. Fluorescence from ICG and MB detected para-aortic SLNs in women with endometrial cancer following uterine injection. Percutaneous SLN detection was also achieved in most women with vulval cancer. No adverse reactions associated with the use of either dyes were observed.ConclusionsThis study demonstrated the successful clinical application of a novel NIR fluorescence imaging system for SLN detection across different gynaecological cancers. We showcased the first in human imaging, during the same procedure, of two fluorescence dyes in women with endometrial cancer.Electronic supplementary materialThe online version of this article (doi:10.1186/s13104-015-1576-z) contains supplementary material, which is available to authorized users.

A practical guide for the use of indocyanine green and methylene blue in fluorescence‐guided abdominal surgery

“…However, if the resected lymph nodes were not involved, which is often the case in early stage cervical cancer, patients underwent unnecessarily lymphadenectomy. This could be prevented by performing SLN mapping, for instance with NIR fluorescence imaging, as shown in different studies . These studies, performed in early stage cervical cancer, showed detection rates varying from 60% to 100%.…”

“…However, in some centers fluorescence imaging is used for SLN mapping and incorporated in standard care . Nineteen studies showed that fluorescence imaging is useful, indicating high detection rates of lymph nodes, varying from 68 to 100% . Laios et al showed the lowest detection rate (68%), which was probably caused by the learning process as visualized by a learning curve.…”

Role of Sentinel Node Biopsy in Endometrial Cancer

“…All of the authors (and many not mentioned here) agree that ICG offers the highest detection rates comparable to those of the standard 99m Tcblue technique but with superior bilaterality [11,26]. ICG achieves greater diffusion; better visualisation; greater bilateral detection, which translates into a lower risk of lymphadenectomy (61% with MB vs. 39% with ICG; p < 0.001 [63]); a shorter surgical time and long-term financial savings and can obviate the need for an injection of radiotracer [68]. It was initially stated that ICG represented an increase in the number of resected SLNs, a finding that became standard with experience in the technique [69].…”

Electrically tunable fluidic lens imaging system for laparoscopic fluorescence-guided surgery

“…The use of fluorescence in the near infrared (NIR) spectral region has shown that penetration depths of the order of 10s of mm can be achieved [7], at the expense of poorer spatial resolution. More importantly, autofluorescence is significantly reduced [8].…”

“…Fluorescence-guided surgery (FGS) in the NIR has been successfully performed in a number of laparoscopic procedures including sentinel lymph node (SLN) detection [7,11,12], cholangiography [13], ureter imaging [14] and nerve identification [15] amongst others. These advances have been driven by the availability of fluorescent dyes that are approved for clinical use in off-label studies (i.e.…”