Mike Wenzel, Florestan Koll, Benedikt Hoeh, Clara Humke, Carolin Siech, Nicolai Mader, Amir Sabet, Daniel Groener, Thomas Steuber, Markus Graefen, Tobias Maurer, Christian Brandts, Severine Banek, Felix K H Chun, Philipp Mandel
{"title":"Real-World Comparison of Cabazitaxel Versus <sup>177</sup>Lu-PSMA Radiopharmaceutical Therapy in Metastatic Castration-Resistant Prostate Cancer.","authors":"Mike Wenzel, Florestan Koll, Benedikt Hoeh, Clara Humke, Carolin Siech, Nicolai Mader, Amir Sabet, Daniel Groener, Thomas Steuber, Markus Graefen, Tobias Maurer, Christian Brandts, Severine Banek, Felix K H Chun, Philipp Mandel","doi":"10.2967/jnumed.124.268807","DOIUrl":"10.2967/jnumed.124.268807","url":null,"abstract":"<p><p><sup>177</sup>Lu-vipivotide tetraxetan prostate-specific membrane antigen (<sup>177</sup>Lu-PSMA) therapy is under current scientific investigation and aims to become established in the treatment of metastatic castration-resistant prostate cancer (mCRPC). However, real-world evidence in treatment comparison is scant. <b>Methods:</b> We relied on the FRAMCAP database and compared cabazitaxel versus <sup>177</sup>Lu-PSMA therapy in mCRPC patients regarding progression-free survival (PFS) and overall survival (OS). Sensitivity analyses addressed second- to fourth-line mCRPC treatment to approximate current phase III patient selection criteria. <b>Results:</b> Of 373 patients, 14% received cabazitaxel, 65% received <sup>177</sup>Lu-PSMA, and 21% received both. Patients undergoing <sup>177</sup>Lu-PSMA therapy were significantly older than cabazitaxel patients (median, 72 y vs. 66 y; <i>P</i> < 0.01), and a higher proportion had an Eastern Cooperative Oncology Group score of 2 or more (12% vs. 5.0%, <i>P</i> = 0.1). Rates of a prostate-specific antigen decline of at least 50% were 32% versus 0% for <sup>177</sup>Lu-PSMA versus cabazitaxel. In outcome analyses, significant superior median PFS was observed for <sup>177</sup>Lu-PSMA versus cabazitaxel (13.4 mo vs. 7.1 mo, <i>P</i> < 0.001), even after multivariable adjustment (hazard ratio, 0.38; <i>P</i> < 0.001). Regarding OS, rates also significantly differed, with median OS of 14.7 mo versus 16.5 mo versus 29.6 mo for cabazitaxel versus <sup>177</sup>Lu-PSMA versus both treatments (<i>P</i> < 0.01). In sensitivity analyses of second- to fourth-line mCRPC treatment, PFS rates and median OS rates for cabazitaxel versus <sup>177</sup>Lu-PSMA versus both therapies qualitatively remained the same as for the entire cohort. <b>Conclusion:</b> In a real-world setting, <sup>177</sup>Lu-PSMA provides significantly better PFS and qualitatively better OS rates than does cabazitaxel chemotherapy and should therefore be considered a valuable treatment option for advanced mCRPC patients according to the European Medicines Agency approval.</p>","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":"61-66"},"PeriodicalIF":0.0,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142635225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ekin Ermiş, Nicolas Bachmann, Katharina Lutz, Thomas Pyka
{"title":"Meningioma Revisited: Should Whole-Body Staging with [<sup>68</sup>Ga]Ga-DOTATOC PET/CT of High-Grade Meningiomas Become Standard Practice?","authors":"Ekin Ermiş, Nicolas Bachmann, Katharina Lutz, Thomas Pyka","doi":"10.2967/jnumed.124.267934","DOIUrl":"10.2967/jnumed.124.267934","url":null,"abstract":"","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":"162"},"PeriodicalIF":0.0,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142690145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Is Routine Dosimetry Really Happening?","authors":"John J Sunderland","doi":"10.2967/jnumed.124.267830","DOIUrl":"https://doi.org/10.2967/jnumed.124.267830","url":null,"abstract":"","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":"66 1","pages":"20-23"},"PeriodicalIF":0.0,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142928941","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Thomas A Hope, Jeremie Calais, Ajit H Goenka, Uwe Haberkorn, Mark Konijnenberg, Jonathan McConathy, Daniela E Oprea-Lager, Laura Trimnal, Elcin Zan, Ken Herrmann, Christophe M Deroose
{"title":"SNMMI Procedure Standard/EANM Practice Guideline for Fibroblast Activation Protein (FAP) PET.","authors":"Thomas A Hope, Jeremie Calais, Ajit H Goenka, Uwe Haberkorn, Mark Konijnenberg, Jonathan McConathy, Daniela E Oprea-Lager, Laura Trimnal, Elcin Zan, Ken Herrmann, Christophe M Deroose","doi":"10.2967/jnumed.124.269002","DOIUrl":"10.2967/jnumed.124.269002","url":null,"abstract":"","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":"26-33"},"PeriodicalIF":0.0,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11705787/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142690147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A Banner Year for Nuclear Medicine, Molecular Imaging, and Theranostics.","authors":"Cathy Sue Cutler","doi":"10.2967/jnumed.6512PresMessage","DOIUrl":"https://doi.org/10.2967/jnumed.6512PresMessage","url":null,"abstract":"","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":"65 12","pages":"7A-8A"},"PeriodicalIF":0.0,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142775935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Changed Regulation Enables Pragmatic Solution for Cancer Patients.","authors":"Uwe Holzwarth","doi":"10.2967/jnumed.124.268945","DOIUrl":"10.2967/jnumed.124.268945","url":null,"abstract":"","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":"1850"},"PeriodicalIF":0.0,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142607062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Matteo Bauckneht, Francesco Lanfranchi, Liliana Belgioia
{"title":"Reply: One Bite from the Apple, One Bite from the Orange in the PRECISE-MDT Study and Limitations of Retrospective Study Design and Potential Bias in the PRECISE-MDT Study.","authors":"Matteo Bauckneht, Francesco Lanfranchi, Liliana Belgioia","doi":"10.2967/jnumed.124.268781","DOIUrl":"10.2967/jnumed.124.268781","url":null,"abstract":"","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":"1986"},"PeriodicalIF":0.0,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142484325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andreas Helisch, Clemens Kratochwil, Christian Kleist, Susanne Krämer, Juan Jose Rosales Castillo, Katharina Dendl, Hendrik Rathke, Isabelle von Goetze, Mathias Schreckenberger, Dirk Jäger, Thomas Lindner, Walter Mier, Frederik Giesel, Uwe Haberkorn, Manuel Röhrich
{"title":"Feasibility, Tolerability, and Preliminary Clinical Response of Fractionated Radiopharmaceutical Therapy with <sup>213</sup>Bi-FAPI-46: Pilot Experience in Patients with End-Stage, Progressive Metastatic Tumors.","authors":"Andreas Helisch, Clemens Kratochwil, Christian Kleist, Susanne Krämer, Juan Jose Rosales Castillo, Katharina Dendl, Hendrik Rathke, Isabelle von Goetze, Mathias Schreckenberger, Dirk Jäger, Thomas Lindner, Walter Mier, Frederik Giesel, Uwe Haberkorn, Manuel Röhrich","doi":"10.2967/jnumed.124.268386","DOIUrl":"10.2967/jnumed.124.268386","url":null,"abstract":"<p><p>Radiopharmaceutical therapies (RPTs) based on fibroblast activation protein (FAP) and FAP inhibitors (FAPIs) are a new option for progressive metastatic cancer in patients pretreated multiple times. To date, published in-human data refer to initial experiences with β-emitting <sup>90</sup>Y- and <sup>177</sup>Lu-based RPT. However, the short tumor retention time of FAPI ligands is considered a major limitation of FAPI RPT. Therefore, fractionated FAPI RPT with <sup>213</sup>Bi, an α-emitter with a half-life of 46 min, appears to be a promising FAPI RPT regimen. Here, we report on our initial experiences with regard to the feasibility, tolerability, and response of fractionated <sup>213</sup>Bi-FAPI-46 RPT. <b>Methods:</b> Six patients (4 women and 2 men) with progressive metastatic solid tumors (3 colon cancer, 1 anal cancer, 1 breast cancer, and 1 prostate cancer) aged 16-77 y were treated with a mean of 1,609 MBq of <sup>213</sup>Bi-FAPI-46, fractionated into 53 single applications (range, 5-12 RPT applications per patient; mean, 8.8 applications) over a period of up to 107 h per patient. Of the 6 patients, 4 patients received adjuvant treatment with pembrolizumab. <sup>18</sup>F-FDG (4 patients) and <sup>68</sup>Ga-FAPI-46 (5 patients) PET/CT scans were performed before and after RPT. PET images were assessed visually and by calculating total lesion glycolysis and total lesion FAPI. <b>Results:</b> RPT with <sup>213</sup>Bi-FAPI-46 was well tolerated without adverse side effects. In terms of visual response assessment, there was 1 partial response (16.7%), 1 patient with stable disease (16.7%), and 4 patients with progressive disease (66.7%). Concordantly, total lesion glycolysis and total lesion FAPI were decreased in the responding patient (not applicable and -24.3%, respectively), slightly decreased in the patient with stable disease (-10.6% and -5.9%, respectively), and increased in the 4 patients with progression (mean, +104.4% and +321.3%, respectively). <b>Conclusion:</b> Fractionated FAPI RPT with the short-half-life α-emitter <sup>213</sup>Bi-FAPI-46 is a promising approach that matches the pharmacokinetics of FAPI-46 better than the <sup>177</sup>Lu- or <sup>90</sup>Y-labeled compounds. In this pilot project, fractionated RPT with <sup>213</sup>Bi-FAPI-46 showed good clinical tolerability and even led to regressive or stable disease in the short term in 2 of 6 patients. Further studies with larger patient cohorts are required to evaluate the actual efficacy and long-term effects of this variant of FAPI RPT.</p>","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":"1917-1922"},"PeriodicalIF":0.0,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11619590/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142549805","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Limitations of Retrospective Study Design and Potential Bias in the PRECISE-MDT Study.","authors":"Tadashi Watabe","doi":"10.2967/jnumed.124.268447","DOIUrl":"10.2967/jnumed.124.268447","url":null,"abstract":"","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":"1985"},"PeriodicalIF":0.0,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142484323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Wei Huang, Min Cao, Yanfei Wu, You Zhang, Shuxian An, Xinbing Pan, Xinyuan Zhou, Hongda Shao, Yihui Guan, Gang Huang, Fabrizia Gelardi, Arturo Chiti, Fang Xie, Jianjun Liu, Weijun Wei
{"title":"Immuno-PET/CT Imaging of Trop2 with [<sup>18</sup>F]AlF-RESCA-T4 Differentiates Lung Cancer from Inflammation.","authors":"Wei Huang, Min Cao, Yanfei Wu, You Zhang, Shuxian An, Xinbing Pan, Xinyuan Zhou, Hongda Shao, Yihui Guan, Gang Huang, Fabrizia Gelardi, Arturo Chiti, Fang Xie, Jianjun Liu, Weijun Wei","doi":"10.2967/jnumed.124.268751","DOIUrl":"10.2967/jnumed.124.268751","url":null,"abstract":"<p><p>Immuno-PET/CT imaging, a branch of molecular imaging, can noninvasively and specifically visualize biomarker expression across the body. Trophoblast cell surface antigen 2 (Trop2) is a pan-cancer biomarker and plays a crucial role in tumorigenesis through multiple signaling pathways. The study aims to develop and translate novel Trop2 single-domain antibody (sdAb) tracers for clinical use. <b>Methods:</b> Two sdAbs (i.e., His-tagged T4 and His-tag-free RT4) are recombinantly expressed in Chinese hamster ovary cells. The purities and binding kinetics are determined by sodium dodecyl sulfate polyacrylamide gel electrophoresis, high-performance liquid chromatography, and surface plasmon resonance assays. The AlF restrained complexing agent (RESCA) method is applied to develop <sup>18</sup>F-labeled sdAb tracers ([<sup>18</sup>F]AlF-RESCA-T4 and [<sup>18</sup>F]AlF-RESCA-RT4), followed by thorough preclinical imaging and blocking studies on tumor-bearing mice and a pilot clinical trial evaluating the clinical imaging safety and feasibility of [<sup>18</sup>F]AlF-RESCA-T4 immuno-PET/CT. <b>Results:</b> [<sup>18</sup>F]AlF-RESCA-T4 and [<sup>18</sup>F]AlF-RESCA-RT4 possess high radiochemical purities. Preclinical imaging in the T3M-4 tumor model revealed prominent uptake (percentage injected dose/g) of [<sup>18</sup>F]AlF-RESCA-T4 (11.13 ± 1.53, <i>n</i> = 4) and [<sup>18</sup>F]AlF-RESCA-RT4 (8.83 ± 1.22, <i>n</i> = 4), which were significantly reduced by coinjection of unlabeled T4 and RT4 in blocking studies. The His-tag removal strategy further optimized the probe's in vivo pharmacokinetics and reduced renal radioactivity accumulation without significantly decreasing tumor uptake. In a pilot clinical trial, [<sup>18</sup>F]AlF-RESCA-T4 immuno-PET/CT showed promising potency in annotating Trop2 expression and differentiating tumors from inflammatory diseases such as tuberculosis. <b>Conclusion:</b> [<sup>18</sup>F]AlF-RESCA-T4 and [<sup>18</sup>F]AlF-RESCA-RT4 can specifically annotate Trop2 expression. Clinical [<sup>18</sup>F]AlF-RESCA-T4 immuno-PET/CT imaging can screen patients for Trop2-targeted therapies and differentiate lung inflammation from cancer.</p>","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":"1904-1910"},"PeriodicalIF":0.0,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142635200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}