{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,13]],"date-time":"2026-06-13T06:37:08Z","timestamp":1781332628795,"version":"3.54.1"},"reference-count":45,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2022,9,13]],"date-time":"2022-09-13T00:00:00Z","timestamp":1663027200000},"content-version":"unspecified","delay-in-days":12,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,8,25]]},"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      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 (\n                      <jats:sup>99m<\/jats:sup>\n                      Tc) 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\n                      <jats:sup>99m<\/jats:sup>\n                      Tc, 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\n                      <jats:sup>99m<\/jats:sup>\n                      Tc and blue dye, we aim to provide prospective evidence on the non-inferiority of ICG with NIR fluorescence imaging.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      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\u2013IB2 or IIA1 cervical cancer receiving primary surgical treatment. All patients undergo SLN mapping with ICG and NIR fluorescence imaging in adjunct to mapping with\n                      <jats:sup>99m<\/jats:sup>\n                      Tc (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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The current study is approved by the Medical Ethics Research Committee Utrecht (reference number 21\u2013014). Findings arising from this study will be disseminated in peer-reviewed journals, academic conferences and through patient organisations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>NL9011 and EudraCT 2020-005134-15.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-061829","type":"journal-article","created":{"date-parts":[[2022,9,13]],"date-time":"2022-09-13T11:46:11Z","timestamp":1663069571000},"page":"e061829","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Fluorescent Indocyanine Green versus Technetium-99m and Blue Dye for Bilateral SENTinel Lymph Node Detection in Stage I\u2013IIA Cervical Cancer (FluoreSENT): protocol for a non-inferiority study"],"prefix":"10.1136","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0534-7778","authenticated-orcid":false,"given":"Ilse G T","family":"Baeten","sequence":"first","affiliation":[{"name":"Department of Gynaecologic Oncology, Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacob P","family":"Hoogendam","sequence":"additional","affiliation":[{"name":"Department of Gynaecologic Oncology, Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arthur J A T","family":"Braat","sequence":"additional","affiliation":[{"name":"Department of Radiology and Nuclear Medicine, Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wouter B","family":"Veldhuis","sequence":"additional","affiliation":[{"name":"Department of Radiology and Nuclear Medicine, Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geertruida N","family":"Jonges","sequence":"additional","affiliation":[{"name":"Department of Pathology, Division of Laboratory, Pharmacy and Biomedical Genetics, University Medical Center Utrecht, Utrecht, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ina M","family":"J\u00fcrgenliemk-Schulz","sequence":"additional","affiliation":[{"name":"Department of Radiotherapy, Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald P","family":"Zweemer","sequence":"additional","affiliation":[{"name":"Department of Gynaecologic Oncology, Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cornelis G","family":"Gerestein","sequence":"additional","affiliation":[{"name":"Department of Gynaecologic Oncology, Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2022,9,13]]},"reference":[{"key":"2025120520512445000_12.9.e061829.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ygyno.2011.11.037"},{"key":"2025120520512445000_12.9.e061829.2","doi-asserted-by":"publisher","DOI":"10.1136\/ijgc-2019-000332"},{"key":"2025120520512445000_12.9.e061829.3","doi-asserted-by":"publisher","DOI":"10.1136\/ijgc-2018-000010"},{"key":"2025120520512445000_12.9.e061829.4","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.32.0432"},{"key":"2025120520512445000_12.9.e061829.5","doi-asserted-by":"publisher","DOI":"10.1016\/j.ygyno.2007.05.010"},{"key":"2025120520512445000_12.9.e061829.6","doi-asserted-by":"crossref","first-page":"96","DOI":"10.1016\/j.ygyno.2017.02.005","article-title":"Sensitivity and negative predictive value for sentinel lymph node biopsy in women with early-stage cervical cancer","volume":"145","author":"Salvo","year":"2017","journal-title":"Gynecol Oncol"},{"key":"2025120520512445000_12.9.e061829.7","doi-asserted-by":"crossref","first-page":"93","DOI":"10.1016\/j.ygyno.2019.10.027","article-title":"Risk factors for failure of bilateral sentinel lymph node mapping in early-stage cervical cancer","volume":"156","author":"Balaya","year":"2020","journal-title":"Gynecol Oncol"},{"key":"2025120520512445000_12.9.e061829.8","doi-asserted-by":"publisher","DOI":"10.1016\/j.ygyno.2005.04.016"},{"key":"2025120520512445000_12.9.e061829.9","doi-asserted-by":"crossref","first-page":"559","DOI":"10.1016\/j.ygyno.2015.09.076","article-title":"The sentinel node procedure in early stage cervical cancer, taking the next step; 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