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. 2022 Sep 13;12(9):e061829.
doi: 10.1136/bmjopen-2022-061829.

Fluorescent Indocyanine Green versus Technetium-99m and Blue Dye for Bilateral SENTinel Lymph Node Detection in Stage I-IIA Cervical Cancer (FluoreSENT): protocol for a non-inferiority study

Ilse G T Baeten  1 , Jacob P Hoogendam  2 , Arthur J A T Braat  3 , Wouter B Veldhuis  3 , Geertruida N Jonges  4 , Ina M Jürgenliemk-Schulz  5 , Ronald P Zweemer  2 , Cornelis G Gerestein  2
Affiliations

Fluorescent Indocyanine Green versus Technetium-99m and Blue Dye for Bilateral SENTinel Lymph Node Detection in Stage I-IIA Cervical Cancer (FluoreSENT): protocol for a non-inferiority study

Ilse G T Baeten et al. BMJ Open. .

Abstract

Introduction: Nowadays, two predominant methods for detecting sentinel lymph nodes (SLNs) in cervical cancer are in use. The most conventional method is a combination of a radiotracer, technetium-99m (99mTc) and blue dye. More recently, another method for SLN mapping using indocyanine green (ICG) is becoming widely accepted. ICG is a fluorescent dye, visualised intraoperatively with near-infrared (NIR) fluorescence imaging, providing real-time visual navigation. The presumed advantages of ICG over 99mTc, that is, being cheaper, non-radioactive and logistically more attractive, are only valuable if its detection rate proves to be at least non-inferior. Before omitting the well-functioning and evidence-based combined approach of 99mTc and blue dye, we aim to provide prospective evidence on the non-inferiority of ICG with NIR fluorescence imaging.

Methods and analysis: We initiated a prospective non-inferiority study with a paired comparison of both SLN methods in a single sample of 101 patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA-IB2 or IIA1 cervical cancer receiving primary surgical treatment. All patients undergo SLN mapping with ICG and NIR fluorescence imaging in adjunct to mapping with 99mTc (including single photon emission computed tomography with X-ray computed tomography (SPECT/CT)) and blue dye. Surgeons start SLN detection with ICG while being blinded for the preoperative outcome of SPECT/CT to avoid biased detection with ICG. Primary endpoint of this study is bilateral SLN detection rate of both methods (ie, detection of at least one SLN in each hemipelvis). Since we compare strategies for SLN mapping that are already applied in current daily practice for different types of cancer, no additional risks or burdens are expected from these study procedures.

Ethics and dissemination: The current study is approved by the Medical Ethics Research Committee Utrecht (reference number 21-014). Findings arising from this study will be disseminated in peer-reviewed journals, academic conferences and through patient organisations.

Trial registration number: NL9011 and EudraCT 2020-005134-15.

Keywords: Diagnostic radiology; GYNAECOLOGY; Gynaecological oncology; Nuclear radiology; ONCOLOGY.

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Conflict of interest statement

Competing interests: RPZ is a proctor for robot-assisted surgery in gynaecological oncology on behalf of Intuitive Surgical.

Figures

Figure 1
Figure 1
Flowchart of study procedures. Blue boxes represent the current standard of care; red boxes represent the study-specific procedures. 99mTc, technetium-99m nanocolloid; SPECT-CT, single photon emission computed tomography with X-ray computed tomography; blue dye, patent blue; ICG, indocyanine green; NIR, near-infrared; SLN(s), sentinel lymph node(s).
Figure 2
Figure 2
Fluorescence-guided surgery showing lymphatic vessels (left) and sentinel lymph node (right).
See this image and copyright information in PMC

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References

    1. Cibula D, Abu-Rustum NR, Dusek L, et al. . Prognostic significance of low volume sentinel lymph node disease in early-stage cervical cancer. Gynecol Oncol 2012;124:496–501. 10.1016/j.ygyno.2011.11.037 - DOI - PubMed
    1. Lecuru FR, McCormack M, Hillemanns P, et al. . SENTICOL III: an international validation study of sentinel node biopsy in early cervical cancer. A GINECO, ENGOT, GCIG and multicenter study. Int J Gynecol Cancer 2019;29:829–34. 10.1136/ijgc-2019-000332 - DOI - PMC - PubMed
    1. Cibula D, Dusek J, Jarkovsky J, et al. . A prospective multicenter trial on sentinel lymph node biopsy in patients with early-stage cervical cancer (SENTIX). Int J Gynecol Cancer 2019;29:212–5. 10.1136/ijgc-2018-000010 - DOI - PubMed
    1. Lécuru F, Mathevet P, Querleu D, et al. . Bilateral negative sentinel nodes accurately predict absence of lymph node metastasis in early cervical cancer: results of the SENTICOL study. J Clin Oncol 2011;29:1686–91. 10.1200/JCO.2010.32.0432 - DOI - PubMed
    1. van de Lande J, Torrenga B, Raijmakers PGHM, et al. . Sentinel lymph node detection in early stage uterine cervix carcinoma: a systematic review. Gynecol Oncol 2007;106:604–13. 10.1016/j.ygyno.2007.05.010 - DOI - PubMed