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The sentinel node (SN) procedure holds the promise to identify the diagnostically relevant first tumor-draining nodes while limiting the complication rate associate with a pelvic lymph node dissection (PLND), still considered the gold standard of nodal staging. Following an initial technical feasibility study, we prospectively evaluated the clinical impact of using peri-tumoral injections with the hybrid tracer indocyanine green (ICG)-<jats:sup>99m<\/jats:sup>Tc-nanocolloid for SN procedures in bladder cancer<jats:italic>.<\/jats:italic>\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>A total of 30 patients with vhNMIBC or MIBC, cN0M0 (with or without neo-adjuvant systemic therapy) scheduled for radical cystectomy with pelvic lymph node dissection (PLND) were enrolled in a prospective study. Patients received four to six transurethral peritumoral injections of ICG-<jats:sup>99m<\/jats:sup>Tc-nanocolloid into the bladder for SN tracing. Preoperative lymphoscintigraphy and Single Photon Emission Computed Tomography (SPECT)\/CT was performed the day before surgery.<\/jats:p>\n            <jats:p>The intraoperative detection of SNs was supported by both fluorescence (utilizing a hand-held camera or fluorescence laparoscope) and radio-guidance (using hand-held, laparoscopic or DROP-IN probe tracing). Resected specimens, comprising both SNs and PLND tissue, were analyzed by the pathologist. Complications related to the tracer injection were documented and cancer-specific survival (CSS) and overall survival (OS) were studied using Kaplan\u2013Meier survival curves.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>SPECT\/CT imaging revealed 31 SNs in 19 patients with non-visualization of SN in 11 patients (36.7%). During surgery, 4 additional SNs were identified based on fluorescent signals in 3 patients. In 1 patient who underwent open cystectomy, ex vivo evaluation of the PLND-specimen revealed an additional radioactive SN.<\/jats:p>\n            <jats:p>The PLND yielded 592 lymph nodes (LNs; median 17 LNs\/patient). In 5 out of 35 SNs (14.2%; no additional tumor positive LN in complementary PLND) and 3 out of 592 LNs (0.5%; 2 patients with non-visualization of SN) were identified as tumor-positive upon pathological evaluation.<\/jats:p>\n            <jats:p>At mean follow up of 82\u00a0months (SD\u2009\u00b1\u20097.1\u00a0months) 17% of patients died of disease. The 2 patients with non-visualization of SN and nodal metastases (0%) did worse than SN positive patients (75%). Of the 24 patients classified as pN0 8% died.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>Preoperative SN-visualization on SPECT\/CT was achieved in the majority of patients. Patients with SN non-visualization had an increased risk of nodal metastases and poorer outcome. In patients with metastases in the SN no additional nodal metastases were found in the complementary PLND.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s00259-025-07240-z","type":"journal-article","created":{"date-parts":[[2025,4,5]],"date-time":"2025-04-05T12:10:22Z","timestamp":1743855022000},"page":"3653-3661","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Prospective clinical study of sentinel node detection in bladder cancer using a hybrid tracer \u2013 Towards replacement of pelvic lymph node dissection in cases with sentinel node visualization on SPECT\/CT?"],"prefix":"10.1007","volume":"52","author":[{"given":"E. J.","family":"van Gennep","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Pisano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G. 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Approval was granted by the Ethics Committee of NKI-AvL 2014, M14HSN study protocol.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"The authors affirm that human research participants provided informed consent for publication of the images in Figs.\u00a0,\u00a0 and","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publish"}},{"value":"The authors have no relevant financial or non-financial interests to disclose.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}