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On the basis of its excellent in vitro (logD, plasma protein binding, PSMA-affinity, internalization) and in vivo (stability, clearance kinetics, tumor uptake in LNCaP and PC3-PIp tumor-bearing mice) profile, [\n                      <jats:sup>99m<\/jats:sup>\n                      Tc]Tc-PSMA-HSG was selected as the clinical lead compound. Five patients with primary and recurrent prostate cancer underwent [\n                      <jats:sup>99m<\/jats:sup>\n                      Tc]Tc-PSMA-HSG SPECT\/CT and RGS. Tracer dosimetry was calculated using a MIRDcalc v1.22 protocol.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The PSMA affinity (IC\u2085\u2080=38.4\u2009\u00b1\u20095.3 nM), hydrophilicity (logD =\u20132.94), and human plasma protein binding of [\n                      <jats:sup>99m<\/jats:sup>\n                      Tc]Tc-PSMA-HSG were all nearly identical to those of the non-fluorescent parent compound [\n                      <jats:sup>99m<\/jats:sup>\n                      Tc]Tc-PSMA-I&amp;S. Tumor uptake in mice was 11.8\u2009\u00b1\u20091.5%ID\/g at 6\u00a0h p.i. (vs. 6.4\u2009\u00b1\u20091.0%ID\/g for [\n                      <jats:sup>99m<\/jats:sup>\n                      Tc]Tc-PSMA-I&amp;S). In and ex vivo fluorescence imaging in mice confirmed tumor localization with high signal-to-background ratios. In patients, [\n                      <jats:sup>99m<\/jats:sup>\n                      Tc]Tc-PSMA-HSG showed faster clearance and less background uptake than [\n                      <jats:sup>99m<\/jats:sup>\n                      Tc]Tc-PSMA-I&amp;S, with notably reduced salivary gland and intestinal accumulation, but a slightly higher whole body effective dose (0.011\u2009\u00b1\u20090.003 vs. 0.0052 mSv\/MBq). Intraoperative gamma detection revealed lymph node metastases in 6\/6 tracer-avid lesions, which were confirmed by PSMA-HSG fluorescence microscopy and histopathology. The specificity, selectivity, NPV and PPV of [\n                      <jats:sup>99m<\/jats:sup>\n                      Tc]Tc-PSMA-HSG in RGS were 100%, respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      The hybrid tracer [\n                      <jats:sup>99m<\/jats:sup>\n                      Tc]Tc-PSMA-HSG demonstrates high specificity and favorable pharmacokinetics. Its successful first-in-human application highlights its translational potential for precise intraoperative detection of PSMA-positive lymph node metastases.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00259-025-07623-2","type":"journal-article","created":{"date-parts":[[2025,11,14]],"date-time":"2025-11-14T03:56:37Z","timestamp":1763092597000},"page":"2974-2993","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["[99mTc]Tc-PSMA-HSG for PSMA-targeted Hybrid Surgical Guidance: a new addition to the PSMA-I&amp;S\/I&amp;T family"],"prefix":"10.1007","volume":"53","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1928-6913","authenticated-orcid":false,"given":"Margret","family":"Schottelius","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Viertl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tessa","family":"Buckle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H\u00e9l\u00e8ne","family":"Koch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Martin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Litvinenko","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marianne","family":"Patt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D. 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Retrospective analysis was approved by the responsible local Ethics Committee of Ludwig-Maximilians-University Munich, Munich, Germany (reference 25-0653). Informed consent statement Informed consent was obtained from all subjects involved in the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"The study was conducted in accordance with the Declaration of Helsinki and its amendments. The administration of [\n                      99m\n                      Tc]Tc-PSMA-HSG complied with the German Medicinal Products Act, Arzneimittelgesetz \u00a7\u00a013.2b, and the responsible regulatory bodies. All patients gave written informed consent prior to injection of the radiotracer. This retrospective evaluation was approved by the local ethics committee of the Ludwig-Maximilians-University Munich (reference number: 25\u20130493).","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 Figure(s) 6 and 7.","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"}}]}}