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PSMA-Directed PET/MRI Enables Noninvasive Diagnosis and Prognosis in Patients with Increased PSA Levels: Results from the Prospective Randomized RAPID Trial. PSA引导的PET/MRI能够对PSA水平升高的患者进行无创诊断和预后:来自前瞻性随机RAPID试验的结果。
Pub Date : 2025-11-20 DOI: 10.2967/jnumed.125.270404
Markus Hartenbach,Sazan Rasul,Bernhard Grubmüller,Gero Kramer,Pascal Baltzer,Thomas Helbich,Matthias Eiber,Sabrina Hartenbach,Marko Grahovac,Martin Susani,Peter Mazal,Wolfgang Wadsak,Holger Einspieler,Michael Weber,Lukas Kenner,Alexander R Haug,Marcus Hacker
Systematic transrectal ultrasound-guided biopsy lacks accuracy in the primary diagnosis of prostate cancer (PCa) and causes side effects. We investigated prostate-specific membrane antigen (PSMA)-targeted PET/MRI as a less-invasive alternative for biopsy guidance and risk assessment. Methods: The RAPID study was a randomized, controlled, single-center, open-label phase 3 trial comparing the diagnostic efficacy of 68Ga-PSMA-11 PET/MRI with systematic transrectal ultrasound-guided prostate biopsy. In total, 220 men with suspected PCa were randomized to either a standard (random 12-core biopsy; RB) group or an image-guided biopsy (IGB) group. Biopsy, prostatectomy histology, and follow-up visits served as references. Results: PET/MRI prospectively predicted 91 of 113 histologically verified tumors, corresponding to a sensitivity of 80.5% and a positive predictive value of 84.3%. Among tumors characterized as ISUP GG of 3 or greater (n = 60), PSMA PET/MRI prospectively detected 95% (n = 57). The IGB group demonstrated slightly higher sensitivity, specificity, positive predictive value, and negative predictive value compared with the RB group (79.3%, 94.7%, 85.2%, 92.2% vs. 74.2%, 88.0%, 71.9%, 89.2%). Seventy-nine patients were eligible for a direct IGB and RB subanalysis, with IGB detecting 15 additional cases. PET/MRI showed high specificity (94%) and negative prediction (86%) for tumor aggressiveness. In a median follow-up period of 3 y, an aggressive course of disease was detected in 25 of 199 patients. RB correlation identified 24 patients with an ISUP GG of 3 or greater with aggressive disease development during follow-up, compared with 23 patients identified by PET/MRI. Negative prediction of both methods was comparably high at 99%; however, PET/MRI overestimated fewer patients (21) as aggressive compared with RB (34). Conclusion: PSMA-targeted PET/MRI-guided biopsy is a reliable, less invasive method for detecting and characterizing PCa in a cohort with moderately increased PSA values, potentially reducing unnecessary biopsies and provides a reliable prognosis of the course of disease. These results support the integration of modern imaging techniques into clinical practice to improve the treatment of PCa.
系统经直肠超声引导活检在前列腺癌(PCa)的初步诊断缺乏准确性,并引起副作用。我们研究了前列腺特异性膜抗原(PSMA)靶向PET/MRI作为活检指导和风险评估的微创替代方法。方法:RAPID研究是一项随机、对照、单中心、开放标签的3期试验,比较68Ga-PSMA-11 PET/MRI与经直肠超声引导的系统性前列腺活检的诊断效果。总共有220名疑似PCa的男性被随机分为标准(随机12芯活检;RB)组或图像引导活检(IGB)组。活检,前列腺切除术组织学和随访作为参考。结果:113例组织学证实的肿瘤中,PET/MRI前瞻性预测91例,敏感性为80.5%,阳性预测值为84.3%。在ISUP GG≥3的肿瘤中(n = 60), PSMA PET/MRI的前瞻性检出率为95% (n = 57)。与RB组相比,IGB组的敏感性、特异性、阳性预测值和阴性预测值略高(79.3%、94.7%、85.2%、92.2% vs. 74.2%、88.0%、71.9%、89.2%)。79例患者符合直接IGB和RB亚分析的条件,其中IGB检测到另外15例。PET/MRI显示肿瘤侵袭性的高特异性(94%)和阴性预测(86%)。在中位随访3年期间,199例患者中有25例出现侵袭性病程。在随访期间,RB相关性鉴定出24例ISUP GG为3或更高的患者伴有侵袭性疾病发展,而PET/MRI鉴定的患者为23例。两种方法的阴性预测均高达99%;然而,与RB(34)相比,PET/MRI高估的侵袭性患者较少(21)。结论:PSA靶向PET/ mri引导活检是一种可靠的、侵入性较小的方法,可在PSA值中度升高的队列中检测和表征PCa,可能减少不必要的活检,并提供可靠的病程预后。这些结果支持将现代成像技术整合到临床实践中,以改善前列腺癌的治疗。
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引用次数: 0
Digital Biopsy and Network Analysis of Dynamic [68Ga]Ga-FAPI-46 Data in Patients with Malignant and Benign Pancreatic Lesions. 胰腺良恶性病变患者动态[68Ga]Ga-FAPI-46数据的数字化活检及网络分析
Pub Date : 2025-11-20 DOI: 10.2967/jnumed.125.270185
Manuel Röhrich,Frederik M Glatting,Magdalena Geisinger,Anna-Maria Spektor,Hans-Georg Buchholz,Joel Wessendorf,Isabelle von Goetze,Jorge Hoppner,Jakob Liermann,Maximilian Knoll,Matthias Lang,Ulrike Heger,Mathias Schreckenberger,Martin Loos,Adriana Tavares,Klaus Herfarth,Jürgen Debus,Uwe Haberkorn,Mark G Macaskill
The pathologies pancreatic ductal adenocarcinomas, inflammatory lesions of the pancreas, postpancreatectomy reactive tissue, and recurrent pancreatic ductal adenocarcinomas all express fibroblast activation protein and are hardly distinguishable by static PET using [68Ga]Ga-labeled fibroblast activation protein inhibitors (FAPIs) combined with CT. Dynamic imaging allows full [68Ga]-Ga-FAPI kinetic profile analysis, highlighting differences among these pathologies. Here, we applied a voxel-level digital biopsy approach combined with network analysis and clustering to characterize healthy, nonmalignant pathologic, and malignant pathologic kinetic signatures. Methods: This monocentric, retrospective study included 47 patients (>18 y) with morphologically unclear pancreatic lesions on CT or MRI and supplemental [68Ga]Ga-FAPI-46 PET/CT in a primary (31 patients) or recurrent (16 patients) setting. Lesions were classified according to biopsy results (primary cases) or CT appearance and clinical course (recurrent cases). Digital biopsy samples (300 voxels) of pancreatic lesions and control organs (muscle, fat, kidneys, liver, and blood) were taken and then masked and imported into an open source visual analytics application. Voxel networks were created with multiple digital biopsy samples from a single scan or digital biopsy samples combined from multiple scans, with a minimum Pearson correlation value of 0.7. A k-nearest-neighbor edge reduction was applied before Markov clustering. Datasets were then unmasked for interpretation. Static PET parameters (SUVmax and SUVmean) and time to peak of pancreatic lesions and control tissues were extracted from isotropic volumes and analyzed by a t test (threshold for significance, P = 0.05). Results: This work created 47 individual networks and 2 combined networks. Within individual networks, voxels tended to arrange and cluster within the sampled volume of interest (VOI; left and right kidneys strongly coclustered). Networks typically arranged into healthy controls, elimination organs, and pathologic (malignant and nonmalignant) regions. Pathologies tended to cluster with high purity (>95% from the same VOI), with multiple clusters per VOI, indicating intralesional heterogeneity. Our analysis approach could differentiate between malignant and nonmalignant pathologies in the primary and recurrence settings. This differentiation was driven by slower FAPI clearance within malignant voxels. Conclusion: The kinetics of [68Ga]Ga-FAPI-46 across the different tissues, coupled with this sampling and analysis approach, allowed the separation and identification of healthy, nonmalignant pathologic, and malignant pathologic clusters and kinetic features that may facilitate diagnosis and warrant further investigation.
胰腺导管腺癌的病理、胰腺炎性病变、胰腺切除术后反应性组织和复发性胰腺导管腺癌均表达成纤维细胞激活蛋白,并且使用[68Ga] ga标记的成纤维细胞激活蛋白抑制剂(FAPIs)结合CT,通过静态PET几乎无法区分。动态成像允许完整的[68Ga]-Ga-FAPI动力学剖面分析,突出这些病理之间的差异。在这里,我们应用了体素水平的数字活检方法,结合网络分析和聚类来表征健康、非恶性和恶性的病理动力学特征。方法:这项单中心回顾性研究纳入了47例(bb0 - 18岁)CT或MRI上形态不明确的胰腺病变,并在原发(31例)或复发(16例)情况下补充了[68Ga]Ga-FAPI-46 PET/CT。根据活检结果(原发病例)或CT表现和临床病程(复发病例)对病变进行分类。采集胰腺病变和控制器官(肌肉、脂肪、肾脏、肝脏和血液)的数字活检样本(300体素),然后将其屏蔽并导入开源可视化分析应用程序。体素网络由来自一次扫描的多个数字活检样本或来自多次扫描的数字活检样本组合而成,Pearson相关值最小为0.7。在马尔可夫聚类之前进行k近邻边约简。然后揭开数据集进行解释。从各向同性体积中提取胰腺病变和对照组织的静态PET参数(SUVmax和SUVmean)和到达峰值时间,并采用t检验(P = 0.05)进行分析。结果:本工作创建了47个单独网络和2个组合网络。在单个网络中,体素倾向于在感兴趣的采样体积内排列和聚集(VOI;左肾和右肾强烈共聚)。网络通常分布在健康对照、消除器官和病理(恶性和非恶性)区域。病理倾向于高纯度聚集(约95%来自同一VOI),每个VOI有多个聚集,表明病变内异质性。我们的分析方法可以区分原发和复发的恶性和非恶性病理。这种分化是由恶性体素内较慢的FAPI清除所驱动的。结论:[68Ga]Ga-FAPI-46在不同组织中的动力学,再加上这种采样和分析方法,可以分离和鉴定健康、非恶性和恶性的病理簇和动力学特征,这些特征可能有助于诊断和进一步研究。
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引用次数: 0
68Ga-PSMA-11 in Staging of Unfavorable Intermediate- and High-Risk Prostate Cancer Reduces Indication for Noncurative Prostatectomy: A Prospective, Multicenter, International IAEA Study 68Ga-PSMA-11在不良中高危前列腺癌分期中减少非治愈性前列腺切除术指征:一项前瞻性、多中心、国际原子能机构研究
Pub Date : 2025-11-13 DOI: 10.2967/jnumed.125.270537
Juliano J. Cerci, Stefano Fanti, Enrique E. Lobato, Rakesh Kumar, Jolanta Kunikowska, Akram Al-Ibraheem, Maisarah Nasir, Francisca Redondo Moneda, Osvaldo Garcia, Mohamad Haidar, Fuad Novruzov, Ozlem Kucuk, Umut Elboga, Murilo de Almeida Luz, Diana Paez
Visual Abstract

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引用次数: 0
Prospective Histopathologic Comparison Between [18F]PSMA-1007 PET/CT and [18F]Fluciclovine PET/CT of Intraprostatic Tumor Detection: The TRACER Study [18F]PSMA-1007 PET/CT与[18F]氟氯叶PET/CT前列腺内肿瘤检测的前瞻性组织病理学比较:示踪研究
Pub Date : 2025-11-13 DOI: 10.2967/jnumed.125.270650
Robert J. Hoekstra, Lisa Peeters, Alexander Beulens, Mark J. Roef, Christel Brouwer, Joost Nederend, Heidi V.N. Küsters-Vandevelde, Harrie P. Beerlage, Diederik J.H. Baas, Diederik M. Somford, Michiel Sedelaar, Jean-Paul A. van Basten, Hendricus J.E.J. Vrijhof

Both [18F]PSMA-1007 PET/CT and [18F]fluciclovine PET/CT scans are commonly used for prostate cancer (PCa) staging. To the best of our knowledge, no head-to-head comparison of these 2 scans for detection of intraprostatic clinically significant PCa (csPCa) has been published. Methods: A multicenter prospective histopathologic validation study was conducted from October 2020 to February 2023. Patients with newly diagnosed biopsy-proven intermediate- or high-risk PCa scheduled for robot-assisted radical prostatectomy (RARP) were consecutively included. Before RARP, patients underwent both [18F]PSMA-1007 PET/CT as well as [18F]fluciclovine PET/CT. The diagnostic accuracy of [18F]PSMA-1007 PET/CT and [18F]fluciclovine PET/CT for intraprostatic PCa detection and localization was established by histopathologic examination of the prostate specimen as reference. Sensitivity, specificity, positive predictive value, and negative predictive value were compared. Results were based on per-lesion analysis and per-segment analysis. The focus was set on csPCa, defined as the International Society of Urological Pathology grade group 2 or higher. Results: In total, 77 patients were included of whom 57 underwent both PET/CT scans before RARP. Histopathology of the prostate specimen found a total of 88 lesions, of which 68 (77.3%) were qualified as csPCa. Using [18F]PSMA-1007 PET/CT, lesion-based sensitivity for csPCa was 86.8% (95% CI, 75.9%–93.4%), and with [18F]fluciclovine PET/CT, it was 73.5% (95% CI, 61.2%–83.2%). Sensitivity for segment-based csPCa localization was 46.6% (95% CI, 42.4%–50.8%) for [18F]PSMA-1007 PET/CT and 37.3% (95% CI, 33.3%–41.5%) for [18F]fluciclovine PET/CT. Whereas [18F]PSMA-1007 PET/CT has a significantly higher accuracy in the detection and localization of csPCa, [18F]fluciclovine PET/CT visualized all 5 non–[18F]PSMA-1007–avid index tumors. Conclusion: Compared with [18F]fluciclovine PET/CT, [18F]PSMA-1007 PET/CT demonstrated higher sensitivity for csPCa detection. However, in non–[18F]PSMA-1007–avid tumors, the [18F]fluciclovine PET/CT can visualize csPCa and has therefore a potential role in the diagnostic work-up and the clinical decision-making process.

[18F]PSMA-1007 PET/CT和[18F]氟氯叶PET/CT扫描常用于前列腺癌(PCa)分期。据我们所知,这两种扫描在检测前列腺内临床显著性前列腺癌(csPCa)方面的正面比较尚未发表。方法:2020年10月至2023年2月进行了一项多中心前瞻性组织病理学验证研究。新诊断的活检证实的中度或高风险前列腺癌患者计划进行机器人辅助根治性前列腺切除术(RARP)。在RARP之前,患者接受了[18F]PSMA-1007 PET/CT和[18F]氟氯洛夫PET/CT检查。[18F]PSMA-1007 PET/CT和[18F]氟氯叶PET/CT对前列腺内前列腺癌的检测和定位的诊断准确性通过前列腺标本的组织病理学检查作为参考。比较敏感性、特异性、阳性预测值和阴性预测值。结果基于每个病灶和每个节段的分析。重点是csPCa,定义为国际泌尿病理学会2级或更高级别。结果:共纳入77例患者,其中57例在RARP前进行了PET/CT扫描。前列腺标本组织病理学共发现88个病变,其中68个(77.3%)符合csPCa。使用[18F]PSMA-1007 PET/CT,基于病变的csPCa敏感性为86.8% (95% CI, 75.9%-93.4%),使用[18F]氟氯薇PET/CT,敏感性为73.5% (95% CI, 61.2%-83.2%)。[18F]PSMA-1007 PET/CT对基于节段的csPCa定位的敏感性为46.6% (95% CI, 42.4%-50.8%), [18F]氟氯薇PET/CT为37.3% (95% CI, 33.3%-41.5%)。[18F]PSMA-1007 PET/CT在csPCa的检测和定位方面具有更高的准确性,[18F]氟氯氟化PET/CT显示了所有5个非[18F]PSMA-1007 - avid指数肿瘤。结论:与[18F]氟氯烃PET/CT相比,[18F]PSMA-1007 PET/CT对csPCa的检测灵敏度更高。然而,在非[18F] psma -1007阳性肿瘤中,[18F]氟氯叶PET/CT可以显示csPCa,因此在诊断工作和临床决策过程中具有潜在的作用。
{"title":"Prospective Histopathologic Comparison Between [18F]PSMA-1007 PET/CT and [18F]Fluciclovine PET/CT of Intraprostatic Tumor Detection: The TRACER Study","authors":"Robert J. Hoekstra, Lisa Peeters, Alexander Beulens, Mark J. Roef, Christel Brouwer, Joost Nederend, Heidi V.N. Küsters-Vandevelde, Harrie P. Beerlage, Diederik J.H. Baas, Diederik M. Somford, Michiel Sedelaar, Jean-Paul A. van Basten, Hendricus J.E.J. Vrijhof","doi":"10.2967/jnumed.125.270650","DOIUrl":"https://doi.org/10.2967/jnumed.125.270650","url":null,"abstract":"<p>Both [<sup>18</sup>F]PSMA-1007 PET/CT and [<sup>18</sup>F]fluciclovine PET/CT scans are commonly used for prostate cancer (PCa) staging. To the best of our knowledge, no head-to-head comparison of these 2 scans for detection of intraprostatic clinically significant PCa (csPCa) has been published. <strong>Methods:</strong> A multicenter prospective histopathologic validation study was conducted from October 2020 to February 2023. Patients with newly diagnosed biopsy-proven intermediate- or high-risk PCa scheduled for robot-assisted radical prostatectomy (RARP) were consecutively included. Before RARP, patients underwent both [<sup>18</sup>F]PSMA-1007 PET/CT as well as [<sup>18</sup>F]fluciclovine PET/CT. The diagnostic accuracy of [<sup>18</sup>F]PSMA-1007 PET/CT and [<sup>18</sup>F]fluciclovine PET/CT for intraprostatic PCa detection and localization was established by histopathologic examination of the prostate specimen as reference. Sensitivity, specificity, positive predictive value, and negative predictive value were compared. Results were based on per-lesion analysis and per-segment analysis. The focus was set on csPCa, defined as the International Society of Urological Pathology grade group 2 or higher. <strong>Results:</strong> In total, 77 patients were included of whom 57 underwent both PET/CT scans before RARP. Histopathology of the prostate specimen found a total of 88 lesions, of which 68 (77.3%) were qualified as csPCa. Using [<sup>18</sup>F]PSMA-1007 PET/CT, lesion-based sensitivity for csPCa was 86.8% (95% CI, 75.9%–93.4%), and with [<sup>18</sup>F]fluciclovine PET/CT, it was 73.5% (95% CI, 61.2%–83.2%). Sensitivity for segment-based csPCa localization was 46.6% (95% CI, 42.4%–50.8%) for [<sup>18</sup>F]PSMA-1007 PET/CT and 37.3% (95% CI, 33.3%–41.5%) for [<sup>18</sup>F]fluciclovine PET/CT. Whereas [<sup>18</sup>F]PSMA-1007 PET/CT has a significantly higher accuracy in the detection and localization of csPCa, [<sup>18</sup>F]fluciclovine PET/CT visualized all 5 non–[<sup>18</sup>F]PSMA-1007–avid index tumors. <strong>Conclusion</strong>: Compared with [<sup>18</sup>F]fluciclovine PET/CT, [<sup>18</sup>F]PSMA-1007 PET/CT demonstrated higher sensitivity for csPCa detection. However, in non–[<sup>18</sup>F]PSMA-1007–avid tumors, the [<sup>18</sup>F]fluciclovine PET/CT can visualize csPCa and has therefore a potential role in the diagnostic work-up and the clinical decision-making process.</p>","PeriodicalId":22820,"journal":{"name":"The Journal of Nuclear Medicine","volume":"94 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145509941","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}
引用次数: 0
In Vivo PET Imaging of [18F]CHDI-385, a Radioligand for Mutant Huntingtin Aggregates in a Mouse Model of Huntington Disease [18F]CHDI-385,一种亨廷顿病小鼠模型中突变亨廷顿蛋白聚集体的放射配体的体内PET成像
Pub Date : 2025-11-13 DOI: 10.2967/jnumed.125.270660
Franziska Zajicek, Filipe Elvas, Alan Miranda, Jordy Akkermans, Jeroen Verhaeghe, Celia Dominguez, Robert Doot, Vinod Khetarpal, Jonathan Bard, Longbin Liu, Steven Staelens, Daniele Bertoglio
Visual Abstract

视觉文摘
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引用次数: 0
Central Nervous System Biodistribution and Pharmacokinetics of Radiolabeled Tofersen in Rodents, Nonhuman Primates, and Humans 放射标记托佛素在啮齿动物、非人灵长类动物和人类的中枢神经系统生物分布和药代动力学
Pub Date : 2025-11-13 DOI: 10.2967/jnumed.125.270731
Brendon E. Cook, Donald G. McLaren, Jenna M. Sullivan, Georges El Fakhri, Daniel L. Yokell, Mason W. Freeman, Nicolas Currier, Michael E. Oestergaard, Howard Dobson, Jacob Hesterman, Nicolas Salem, Ivan Nestorov, Michael Monine, Laurent Martarello, Karleyton C. Evans, Stephanie Fradette, Toby A. Ferguson, Danielle Graham, Luca Passamonti
Visual Abstract

视觉文摘
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引用次数: 0
The Pelvic Rosetta Classification Project: An Interdisciplinary Proposal for a Lymph Node Map of the Pelvis in Prostate Cancer 盆腔罗塞塔分类项目:前列腺癌盆腔淋巴结图的跨学科建议
Pub Date : 2025-11-06 DOI: 10.2967/jnumed.125.270667
Gernot Ortner, Xenia Hoderlein, Francesco Barbato, Dirk Beyersdorff, Lars Budäus, Irene A. Burger, Matthias Eiber, Markus Graefen, Boris Hadaschik, Alexander Haese, Ken Herrmann, Lennart Maack, Ines Maric, Agostino Mattei, Isabel Rauscher, Georg Salomon, Markus Sauer, Lars Schimmöller, Alexander Schlaefer, Heinz-Peter Schlemmer, Simon K.B. Spohn, Lale Umutlu, Jochen Walz, Christoph Würnschimmel, Daniel Koehler, Tobias Maurer

The Pelvic Rosetta Classification (PRC) project aimed to develop an interdisciplinary, landmark-based pelvic lymph node map for patients with prostate cancer to improve communication between imaging specialists and urologists. Methods: After an intense development phase, we conducted 3 evaluation rounds including 19 clinical experts having consensus meetings after each evaluation round. Experts contoured lymph node areas (LNA) for 2 patients with prostate cancer. Contours were assessed qualitatively and quantitatively. The PRC was further validated by assignment of 30 prostate-specific membrane antigen PET/CT–positive lesions to LNAs. The interrater reliability was calculated using Fleiss κ. Based on the final PRC, a complete contour and a 3-dimensional model were created. Results: Eight pelvic (external iliac, cranial/caudal obturator fossa, dorsal internal iliac, vesico-prostatic pedicle, mesorectal/perirectal, presacral, preprostatic/retropubic) and 4 extrapelvic (common iliac, intercommon, sigmoid, inguinal) LNAs were defined using anatomic landmarks which are consistently recognizable on imaging and intraoperatively. Strong consensus between experts existed for smaller, well-defined LNAs (e.g., preprostatic/retropubic, mesorectal/perirectal LNAs) compared with regions with proportionally large borders (e.g., obturator fossa, vesico-prostatic pedicle LNAs). Overall, moderate agreement (κ = 0.53) was observed during validation. Discrepancies were mostly encountered for lesions adjacent to borders between LNAs. The final contour and 3-dimensional model were approved by all experts. Conclusion: The PRC project showed fair reproducibility and validity. Further external validation is needed to assess its influence on interdisciplinary communication and treatment outcomes.

盆腔Rosetta分类(PRC)项目旨在为前列腺癌患者开发一个跨学科的、基于里程碑的盆腔淋巴结图,以改善成像专家和泌尿科医生之间的沟通。方法:经过激烈的开发阶段,我们进行了3轮评估,包括19名临床专家,每轮评估后召开共识会议。专家绘制了2例前列腺癌患者的淋巴结区域(LNA)。对等高线进行定性和定量评估。PRC通过将30个前列腺特异性膜抗原PET/ ct阳性病变分配给LNAs进一步验证。采用Fleiss κ法计算信度。基于最终的PRC,建立了完整的轮廓和三维模型。结果:8个盆腔(髂外、颅/尾闭孔窝、髂内背、膀胱前列腺蒂、直肠系膜/直肠周围、骶前、前列腺前/耻骨后)和4个盆腔外(髂总、髂间、乙状结肠、腹股沟)LNAs通过影像学和术中一致识别的解剖标志被确定。专家们对较小的、定义明确的LNAs(如前列腺前/耻骨后、直肠系膜/直肠周围LNAs)与比例较大的边界区域(如闭孔窝、膀胱前列腺蒂LNAs)存在强烈的共识。总体而言,在验证期间观察到中度一致性(κ = 0.53)。差异主要发生在毗邻LNAs边界的病变。最终的轮廓线和三维模型得到了所有专家的认可。结论:PRC项目具有良好的再现性和有效性。需要进一步的外部验证来评估其对跨学科交流和治疗结果的影响。
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引用次数: 0
Diagnostic Performance of [18F]PSMA-1007 PET/CT on Proven PSMA-Positive Hepatocellular Carcinoma: A Prospective Clinical Study PSMA-1007 PET/CT对psma阳性肝细胞癌的诊断价值:一项前瞻性临床研究
Pub Date : 2025-11-06 DOI: 10.2967/jnumed.125.270755
Kerstin Michalski, Florian P. Reiter, Aleksander Kosmala, Philipp E. Hartrampf, Simone Seifert, Charis Kalogirou, Stefan Kircher, Thorsten A. Bley, Andreas Geier, Alexander Meining, Andreas K. Buck, Rudolf A. Werner, Alexander Weich

High expression of prostate-specific membrane antigen (PSMA) is not limited to prostate cancer but can be found in other tumor entities, such as hepatocellular carcinoma (HCC), and could possibly be used for theranostic purposes. Our aim was to investigate the diagnostic potential of the hepatobiliary excreted radiotracer [18F]PSMA-1007 on initial staging of HCC. Methods: This prospective clinical study (NCT05547919) included 10 participants (9 men, 1 woman) with treatment-naïve, histopathologically proven PSMA-positive HCC. All participants underwent [18F]PSMA-1007 PET with unenhanced low-dose CT. All scans were analyzed visually and quantitatively. We assessed the SUVmax of the primary tumor and the SUVmean of nonaffected liver parenchyma and calculated tumor-to-background ratios (i.e., SUVmax HCC/SUVmean liver) for each patient. In addition, we assessed possible eligibility for PSMA-directed radiopharmaceutical therapy according to the PROMISE criteria. The presence of local lymph nodes and distant metastases was noted for [18F]PSMA-1007 PET/CT and compared with the results of contrast-enhanced CT of the trunk and MRI of the upper abdomen. Possible prognostic implications of PSMA expression on immunohistochemistry and on [18F]PSMA-1007 PET/CT were compared with progression-free survival (defined as clinical progression, radiographic progression, or death from any cause) using Cox regression. Results: [18F]PSMA-1007 PET showed high uptake in 7 of 10 patients (PROMISE score 2, n = 4; PROMISE score 3, n = 3); mediocre or missing uptake was found in 3 participants (PROMISE score 0, n = 1; PROMISE score 1, n = 2). The median tumor-to-background ratio was 2.7 (interquartile range, 2.65). [18F]PSMA-1007 PET did not reveal new distant metastatic lesions compared with contrast-enhanced CT. In 1 patient, local lymph node metastases were considered PSMA-negative despite high uptake in the primary tumor. Whether assessed ex vivo or in vivo, PSMA expression did not correlate with progression-free survival. Conclusion: [18F]PSMA-1007 can be used depict untreated HCC and shows high uptake relative to background, indicative of excellent image contrast. High tracer accumulation in 70% of the participants suggests a possible use for PSMA-directed radiopharmaceutical therapy in an end-stage setting. However, PSMA expression was not prognostic for outcome, possibly because of the small sample size.

前列腺特异性膜抗原(PSMA)的高表达不仅局限于前列腺癌,也可以在其他肿瘤实体中发现,如肝细胞癌(HCC),并可能用于治疗目的。我们的目的是研究肝胆分泌放射性示踪剂[18F]PSMA-1007对HCC初始分期的诊断潜力。方法:这项前瞻性临床研究(NCT05547919)包括10名参与者(9男1女),treatment-naïve,组织病理学证实psma阳性HCC。所有参与者都接受了[18F]PSMA-1007 PET和未增强的低剂量CT检查。所有扫描结果进行视觉和定量分析。我们评估了原发肿瘤的SUVmax和未受影响的肝实质的SUVmax,并计算了每个患者的肿瘤与背景比(即SUVmax HCC/SUVmean liver)。此外,我们根据PROMISE标准评估了psma定向放射药物治疗的可能资格。[18F]PSMA-1007 PET/CT发现局部淋巴结和远处转移的存在,并与躯干CT增强和上腹部MRI结果进行比较。使用Cox回归将PSMA在免疫组织化学和[18F]PSMA-1007 PET/CT上表达的可能预后意义与无进展生存期(定义为临床进展、影像学进展或任何原因死亡)进行比较。结果:[18F] 10例患者中有7例PSMA-1007 PET显示高摄取(PROMISE评分2,n = 4; PROMISE评分3,n = 3);3名受试者发现摄取一般或缺失(PROMISE评分0,n = 1; PROMISE评分1,n = 2)。肿瘤与背景比值中位数为2.7(四分位数范围为2.65)。[18F]与增强CT相比,PSMA-1007 PET未显示新的远处转移灶。在1例患者中,局部淋巴结转移被认为是psma阴性,尽管在原发肿瘤中摄取很高。无论是体外还是体内评估,PSMA表达与无进展生存期无关。结论:[18F]PSMA-1007可用于描述未治疗的HCC,并且相对于背景显示高摄取,表明具有良好的图像对比度。70%的参与者的高示踪剂积累提示可能在终末期使用psma定向放射性药物治疗。然而,PSMA的表达并不能预测结果,可能是因为样本量小。
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引用次数: 0
Preclinical Validation of [177Lu]Lu-AKIR001, a CD44v6-Targeted Radiotherapeutic Entering First-in-Human Trials cd44v6靶向放疗药物[177Lu]Lu-AKIR001的临床前验证
Pub Date : 2025-11-06 DOI: 10.2967/jnumed.125.270782
Anja C.L. Mortensen, Tabassom Mohajershojai, Amanda Gustafsson, Hanna Berglund, Ram Kumar Selvaraju, Camilla Hofström, Helena Persson, Mats Ohlin, Thuy A. Tran, Anton Forsberg Morén, Piotr Ochniewicz, Jan Zedenius, Peter Bernhardt, Fredrik Y. Frejd, Marika Nestor
Visual Abstract

视觉文摘
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引用次数: 0
Impact of Initial Prostate-Specific Membrane Antigen PET/CT Staging and Prostate-Specific Membrane Antigen–Targeted Biopsy on Treatment Decisions in Prostate Cancer: Results from the Phase 2 DEPROMP Trial 初始前列腺特异性膜抗原PET/CT分期和前列腺特异性膜抗原靶向活检对前列腺癌治疗决策的影响:来自2期DEPROMP试验的结果
Pub Date : 2025-11-06 DOI: 10.2967/jnumed.125.271344
Philipp Krausewitz, Markus Essler, Florian C. Gaertner, Ulrike Attenberger, Julian A. Luetkens, Glen Kristiansen, Marit Bernhardt, Carsten-Henning Ohlmann, Michael Anspach, Matthias Schmid, Robert Nemeth, Jennifer Schmitz, Stefan Hauser, Joerg Ellinger, Manuel Ritter

68Ga-PSMA-11 PET/CT (PSMA PET/CT) is used for staging advanced prostate cancer (PCa); however, its role in initial cancer detection and guiding localized treatment remains uncertain. The primary objective of this study was to assess the impact of upfront PSMA PET/CT on treatment decision-making based on imaging and biopsy-derived information. Methods: In this prospective, phase 2 interventional trial, 230 biopsy- and imaging-naïve men with suspected PCa underwent PSMA PET/CT and multiparametric MRI (mpMRI) before targeted ultrasound fusion and systematic biopsy. Randomized assessor teams independently reviewed histopathology and imaging data from either the mpMRI or the combined mpMRI plus PSMA PET/CT pathway and formulated treatment plans accordingly. Patient recruitment was conducted between 2021 and 2023. Results: Among 137 patients with PCa (9% low-, 35% intermediate-, and 15% high-risk disease), PSMA PET/CT altered management plans in 34% of patients, primarily modifying local treatment strategies, including lymph node dissection (16%), a nerve-sparing procedure (18%), and radiation field adjustments (28%). Systemic therapy escalation was rare (1%). In addition, 2% of patients initiated active treatment, 5% received adjunctive hormone therapy, and 7% underwent metastasis-directed therapy. Upfront PSMA PET/CT prompted treatment intensification at comparable rates in both intermediate-risk (31%) and high-risk (30%) PCa with high interrater agreement (Cohen κ, 0.71; 95% CI, 0.61–0.80). Prostate-specific antigen density of at least 0.15 ng/mL3 (odds ratio, 2.48; 95% CI, 1.22–5.06) and abnormal digital rectal examination (odds ratio, 2.12; 95% CI, 1.03–4.33) predicted PSMA PET/CT–driven changes. Conclusion: Early PSMA PET/CT staging altered treatment strategies for up to one third of patients with intermediate- and high-risk PCa by enhancing metastasis detection and local tumor characterization. Its effect on oncologic and functional outcomes warrants further investigation.

68Ga-PSMA-11 PET/CT (PSMA PET/CT)用于晚期前列腺癌(PCa)分期;然而,它在早期癌症检测和指导局部治疗中的作用仍不确定。本研究的主要目的是评估基于成像和活检信息的PSMA PET/CT对治疗决策的影响。方法:在这项前瞻性的2期介入性试验中,230名活检和imaging-naïve疑似PCa的男性在靶向超声融合和系统活检之前接受了PSMA PET/CT和多参数MRI (mpMRI)检查。随机评估小组独立审查mpMRI或mpMRI + PSMA PET/CT联合途径的组织病理学和成像数据,并制定相应的治疗计划。患者招募在2021年至2023年间进行。结果:在137例PCa患者中(9%为低危,35%为中危,15%为高危),PSMA PET/CT改变了34%患者的治疗计划,主要改变了局部治疗策略,包括淋巴结清扫(16%),神经保留手术(18%)和放射场调整(28%)。全身治疗升级罕见(1%)。此外,2%的患者开始积极治疗,5%接受辅助激素治疗,7%接受转移性治疗。在中度风险(31%)和高风险(30%)PCa中,PSMA PET/CT提示治疗强化的比例相当,且具有较高的评分一致性(Cohen κ, 0.71; 95% CI, 0.61-0.80)。前列腺特异性抗原密度至少为0.15 ng/mL3(优势比2.48,95% CI 1.22-5.06)和直肠指检异常(优势比2.12,95% CI 1.03-4.33)预测PSMA PET/ ct驱动的改变。结论:PSMA PET/CT早期分期通过增强转移检测和局部肿瘤特征,改变了多达三分之一的中高危PCa患者的治疗策略。其对肿瘤和功能结果的影响有待进一步研究。
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引用次数: 0
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The Journal of Nuclear Medicine
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