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Clinical Practice Guidelines for 18F-Fluciclovine 2024 in the Japanese Society of Nuclear Medicine 日本核医学学会18f -氟氯氟醚2024临床实践指南
IF 2.5 4区 医学 Q2 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING Pub Date : 2025-07-25 DOI: 10.1007/s12149-025-02089-6
Kimiteru Ito, Seishi Jinnouchi, Kaoru Kikukawa, Chio Okuyama, Yoshifumi Sugawara, Masami Kawamoto, Koichi Koyama, Kanae Kawai Miyake, Koji Murakami

18F-Fluciclovine was the first 18F-labeled amino acid PET tracer to be approved for clinical use in Japan, receiving regulatory approval in March 2021 and being listed for reimbursement in June 2024. In response to this development, the Japanese Society of Nuclear Medicine initiated the formulation of clinical guidelines to ensure the appropriate use of this radiopharmaceutical in clinical practice. This guideline provides a comprehensive overview of the clinical characteristics of 18F-Fluciclovine in malignant glioma, including indications for use, imaging protocols, interpretation of PET images, and considerations for radiation safety. The Japanese version of this guideline was compiled by a voluntary editorial committee and officially approved by the Japanese Society of Nuclear Medicine on August 16, 2024. The primary objective of this guideline is to consolidate the current scientific evidence on 18F-Fluciclovine and to clarify its clinical utility, appropriate usage, and imaging methodologies. By doing so, it aims to promote the proper implementation of 18F-Fluciclovine in clinical settings and to serve as a reference for future applications related to the expansion of insurance coverage and reimbursement decisions.

It is recommended that PET examinations using 18F-Fluciclovine in Japan be conducted in accordance with this guideline. Although the content is tailored to the Japanese medical system and regulatory framework, the imaging protocols, radiation safety management, and interpretation methods described herein are also expected to be internationally applicable and relevant.

18F-Fluciclovine是日本批准临床使用的第一个18f标记的氨基酸PET示踪剂,于2021年3月获得监管机构批准,并于2024年6月上市报销。针对这一发展,日本核医学学会开始制定临床指南,以确保在临床实践中适当使用这种放射性药物。本指南全面概述了18f -氟西洛夫在恶性胶质瘤中的临床特点,包括使用适应症、成像方案、PET图像的解释以及辐射安全性的考虑。该指南的日文版由自愿编辑委员会编写,并于2024年8月16日由日本核医学学会正式批准。本指南的主要目的是巩固目前关于18f -氟西氯梵的科学证据,并阐明其临床应用、适当使用和影像学方法。这样做的目的是促进18f -氟氯氟在临床环境中的正确实施,并为今后与扩大保险范围和报销决定有关的应用提供参考。建议在日本使用18f -氟西氯薇进行PET检查,按照本指南进行。虽然内容是针对日本医疗系统和监管框架量身定制的,但本文所描述的成像协议、辐射安全管理和解释方法也有望在国际上适用和相关。
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引用次数: 0
Prognostic value of FDG-PET/CT findings in mucosal melanoma of the head and neck treated with carbon ion radiotherapy 碳离子放射治疗头颈部粘膜黑色素瘤FDG-PET/CT表现的预后价值
IF 2.5 4区 医学 Q2 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING Pub Date : 2025-07-25 DOI: 10.1007/s12149-025-02069-w
Ayako Hino, Nobutaka Mizoguchi, Hiroaki Koge, Ryohei Yaguchi, Manatsu Yoshida, Takashi Matsuki, Madoka Furukawa, Tomoaki Nagase, Harumi Mochizuki, Akira Kakiuchi, Shihyao Cheng, Yayoi Yamamoto, Tsunehiro Doiuchi, Hiroaki Kurihara

Objective

To investigate the prognostic value of 18F-fluorodeoxyglucose positron emission tomography-computed tomography (FDG-PET/CT) in patients with mucosal melanoma of the head and neck (MMHN) treated with carbon ion radiotherapy (CIRT).

Methods

This single-center retrospective study included patients with MMHN who underwent CIRT and FDG-PET/CT. Correlations between pre-treatment FDG-PET/CT-derived parameters, including the maximum standardized uptake variable (SUVmax), metabolic tumor volume (MTV) with a 50% threshold, total lesion glycolysis (TLG), bone marrow/liver SUVmax and mean standardized uptake variable (SUVmean) ratios, and spleen/liver SUVmax and SUVmean ratios (SLRmax, SLRmean), with clinical parameters and prognosis were statistically analyzed.

Results

A total of 32 patients with MMHN were enrolled (median age, 72.5 years). The tumor stages were distributed as follows: T3, 17 patients; T4a, 14 patients; T4b, one patient. The median total observation period was 22.6 months, the median overall survival (OS) was 21.6 months, and the median progression-free survival (PFS) was 11.5 months. Thirteen patients (40.6%) died, 10 (31.3%) experienced local recurrence, and 19 (59.4%) had distant metastases during the observation period. The 1 and 3-year survival rates were 78.1% and 62.5%, respectively. FDG-PET/CT showed pronounced positive uptake for all tumors (median SUVmax: 13.8, range 2.7–33.0). SLRmax was high in patients with negative programmed death-ligand 1 expression in the tumor (p = 0.05). PFS was shorter in patients with a high MTV (p = 0.018). In the multivariate analysis, MTV was an independent prognostic factor for PFS (hazard ratio, 2.60; 95% confidence interval, 1.065–6.345; p = 0.036). MTV and TLG were not predictive of OS in the univariate analysis.

Conclusions

FDG-PET/CT showed a strong positive uptake for MMHN. FDG-PET/CT-derived imaging parameters may be significant prognostic biomarkers for predicting tumor progression in patients with MMHN.

目的:探讨18f -氟脱氧葡萄糖正电子发射断层扫描-计算机断层扫描(FDG-PET/CT)对碳离子放疗(CIRT)治疗的头颈部粘膜黑色素瘤(MMHN)患者的预后价值。方法:这项单中心回顾性研究纳入了行CIRT和FDG-PET/CT检查的MMHN患者。统计学分析治疗前FDG-PET/ ct衍生参数,包括最大标准化摄取变量(SUVmax)、50%阈值的代谢肿瘤体积(MTV)、病灶总糖酵解(TLG)、骨髓/肝脏SUVmax和平均标准化摄取变量(SUVmean)比值、脾脏/肝脏SUVmax和平均SUVmean比值(SLRmax、SLRmean)与临床参数和预后的相关性。结果:共有32例MMHN患者入组(中位年龄72.5岁)。肿瘤分期分布如下:T3期17例;T4a, 14例;T4b,一个病人。中位总观察期为22.6个月,中位总生存期(OS)为21.6个月,中位无进展生存期(PFS)为11.5个月。观察期内死亡13例(40.6%),局部复发10例(31.3%),远处转移19例(59.4%)。1年和3年生存率分别为78.1%和62.5%。FDG-PET/CT显示所有肿瘤明显阳性摄取(中位SUVmax: 13.8,范围2.7-33.0)。肿瘤中程序性死亡配体1阴性表达的患者SLRmax较高(p = 0.05)。MTV高的患者PFS较短(p = 0.018)。在多因素分析中,MTV是PFS的独立预后因素(风险比2.60;95%置信区间为1.065-6.345;p = 0.036)。在单变量分析中,MTV和TLG不能预测OS。结论:FDG-PET/CT显示MMHN阳性。FDG-PET/ ct衍生成像参数可能是预测MMHN患者肿瘤进展的重要预后生物标志物。
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引用次数: 0
Distribution patterns of brown adipose tissue on FDG-PET/CT has age characteristics FDG-PET/CT上棕色脂肪组织的分布具有年龄特征。
IF 2.5 4区 医学 Q2 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING Pub Date : 2025-07-24 DOI: 10.1007/s12149-025-02087-8
Yasuchiyo Toyama, Tomoya Kotani, Nagara Tamaki, Sachimi Yamada, Shimpei Akiyama, Yoshitomo Nakai, Taisei Kanayama, Chio Okuyama, Kei Yamada

Purpose

Brown adipose tissue (BAT) contributes to thermoregulation and energy expenditure. Although BAT is abundant in early childhood and declines with age, its distribution across age groups remains unclear. This study examined age-related BAT distribution using fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT).

Materials and methods

A total of 8695 FDG-PET/CT scans performed for clinical purposes were retrospectively reviewed. FDG accumulation with a standardized uptake value (SUV) max > 1.5 in known BAT regions was considered positive. BAT distribution patterns were classified into T-type (positive accumulation in the supraclavicular or axillary region), I-type (positive accumulation in the cervical or paravertebral region without supraclavicular or axillary involvement), lipomatous hypertrophy of the interatrial septum (LHIS)-type (positive accumulation localized only to the LHIS), and others (cases not fitting any type).

Results

BAT accumulation was observed in 78 patients (0.9% prevalence): T-type (18), I-type (39), LHIS-type (18), and others (3). The mean ages for T-type, I-type, LHIS-type, and others were 29.8 ± 17.3, 73.6 ± 18.1, 72.9 ± 12.5, and 67.0 ± 11.5 years, respectively. Patients in the T-type group were significantly younger than those in the I-type- and LHIS-type groups (p < 0.01).

Conclusions

This study identified three BAT distribution types, with T-type occurring in mostly younger compared with the I-type and LHIS type. Recognizing these patterns may improve FDG-PET/CT diagnostic accuracy.

目的:褐色脂肪组织(BAT)有助于体温调节和能量消耗。尽管BAT在儿童早期大量存在,并随着年龄增长而下降,但其在各年龄组中的分布尚不清楚。本研究使用氟脱氧葡萄糖正电子发射断层扫描/计算机断层扫描(FDG-PET/CT)检查了与年龄相关的BAT分布。材料和方法:回顾性分析8695例临床用FDG-PET/CT扫描。已知BAT地区的FDG积累标准吸收值(SUV)最大值为bbb1.5,被认为是阳性的。BAT分布模式分为t型(锁骨上区或腋窝区阳性积聚)、i型(颈椎或椎旁区阳性积聚,不累及锁骨上区或腋窝)、房间隔脂肪瘤性肥厚型(阳性积聚仅局限于LHIS)和其他(不符合任何类型的病例)。结果:78例(0.9%)患者出现BAT积累:t型(18例),i型(39例),lis型(18例),其他3例。t型、i型、lis型和其他型的平均年龄分别为29.8±17.3岁、73.6±18.1岁、72.9±12.5岁和67.0±11.5岁。t型组患者明显比i型和LHIS型患者年轻(p)。结论:本研究确定了三种BAT分布类型,其中t型比i型和LHIS型更年轻。识别这些模式可以提高FDG-PET/CT诊断的准确性。
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引用次数: 0
Innovations in clinical PET image reconstruction: advances in Bayesian penalized likelihood algorithm and deep learning 临床PET图像重建的创新:贝叶斯惩罚似然算法和深度学习的进展。
IF 2.5 4区 医学 Q2 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING Pub Date : 2025-07-18 DOI: 10.1007/s12149-025-02088-7
Kenta Miwa, Tensho Yamao, Fumio Hashimoto, Noriaki Miyaji, Yuto Kamitaka, Masaki Masubuchi, Taisuke Murata, Tokiya Yoshii, Rinya Kobayashi, Shohei Fukuda, Naochika Akiya, Kaito Wachi, Kei Wagatsuma

Recent advances in PET image reconstruction have focused on achieving high image quality and quantitative accuracy. Bayesian penalized likelihood (BPL) algorithms, such as Q.Clear and HYPER Iterative that have been integrated into commercial PET systems offer robust image noise suppression and edge preservation through regularization. In parallel, methods based on deep learning such as SubtlePET, AiCE, uAI® HYPER DLR, and Precision DL have emerged primarily as post-processing techniques. They use trained convolutional neural networks to reduce image noise while preserving lesion contrast. These methods have reduced image acquisition times or reduced radiotracer doses while maintaining diagnostic confidence. uAI® HYPER DPR represents a hybrid approach by embedding deep learning in iterative reconstruction. This review summarizes the technical principles and the clinical performance of BPL and deep learning-based PET reconstruction algorithms, and discusses key considerations such as image quality and quantitative accuracy of PET images. This review should deepen understanding of advanced PET image reconstruction techniques and accelerate their clinical implementation across diverse PET imaging applications.

PET图像重建的最新进展主要集中在实现高图像质量和定量精度上。贝叶斯惩罚似然(BPL)算法,如Q.Clear和HYPER Iterative,已集成到商用PET系统中,通过正则化提供鲁棒的图像噪声抑制和边缘保存。与此同时,基于深度学习的方法,如精妙pet、AiCE、uAI®HYPER DLR和精密DL,主要作为后处理技术出现。他们使用经过训练的卷积神经网络来降低图像噪声,同时保持病变对比度。这些方法减少了图像采集时间或减少了放射性示踪剂剂量,同时保持了诊断的可信度。uAI®HYPER DPR通过在迭代重建中嵌入深度学习代表了一种混合方法。本文综述了基于BPL和基于深度学习的PET重建算法的技术原理和临床表现,并讨论了PET图像的图像质量和定量准确性等关键考虑因素。本综述旨在加深对先进PET图像重建技术的理解,并加快其在不同PET成像应用中的临床应用。
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引用次数: 0
Vision-language model performance on the Japanese Nuclear Medicine Board Examination: high accuracy in text but challenges with image interpretation 视觉语言模型在日本核医学委员会考试中的表现:文本准确性高,但图像解释存在挑战。
IF 2.5 4区 医学 Q2 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING Pub Date : 2025-07-15 DOI: 10.1007/s12149-025-02084-x
Rintaro Ito, Keita Kato, Marina Higashi, Yumi Abe, Ryogo Minamimoto, Katsuhiko Kato, Toshiaki Taoka, Shinji Naganawa

Objective

Vision language models (VLMs) allow visual input to Large Language Models. VLMs have been developing rapidly, and their accuracy is improving rapidly. Their performance in nuclear medicine compared to state-of-the-art models, including reasoning models, is not yet clear. We evaluated state-of-the-art VLMs using problems from the past Japan Nuclear Medicine Board Examination (JNMBE) and assessed their strengths and limitations.

Methods

We collected 180 multiple-choice questions from JNMBE (2022–2024). About one-third included diagnostic images. We used eight latest VLMs. ChatGPT o1 pro, ChatGPT o1, ChatGPT o3-mini, ChatGPT-4.5, Claude 3.7, Gemini 2.0 Flash thinking, Llama 3.2, and Gemma 3 were tested. Each model answered every question three times in a deterministic setting, and the final answer was set by majority vote. Two board-certified nuclear medicine physicians independently provided reference answers, with a third expert resolving disagreements. We calculated overall accuracy with 95% confidence intervals and performed subgroup analyses by question type, content, and exam year.

Results

Overall accuracies ranged from 36.1% (Gemma 3) to 83.3% (ChatGPT o1 pro). ChatGPT o1 pro achieved the highest score (150/180, 83.3% [95% CI: 77.1–88.5%]), followed by ChatGPT o3-mini (82.8%) and ChatGPTo1 (78.9%). All models performed better on text-only questions than on image-based ones; ChatGPT o1 pro correctly answered 89.5% of text questions versus 66.0% of image questions. VLMs demonstrated limitations in handling with questions on Japanese regulations. ChatGPT 4.5 excelled in neurology-related image-based questions (76.9%). Accuracy was slightly lower from 2022 to 2024 for most models.

Conclusions

VLMs demonstrated high accuracy on the JNMBE, especially on text-based questions, but exhibited limitations with image recognition questions. These findings show that VLMs can be a good assistant for text-based questions in medical domains but have limitations when it comes to comprehensive questions that include images. Currently, VLMs cannot replace comprehensive training and expert interpretation. Because VLMs evolve rapidly and exam difficulty varies annually, these findings should be interpreted in that context.

目的:视觉语言模型(VLMs)允许对大型语言模型进行视觉输入。VLMs发展迅速,精度也在迅速提高。与最先进的模型(包括推理模型)相比,它们在核医学中的表现尚不清楚。我们利用过去日本核医学委员会考试(JNMBE)中的问题评估了最先进的VLMs,并评估了它们的优势和局限性。方法:收集JNMBE(2022-2024)试题180道选择题。大约三分之一包括诊断图像。我们使用了8个最新的vlm。ChatGPT 01 pro、ChatGPT 01、ChatGPT 03 -mini、ChatGPT-4.5、Claude 3.7、Gemini 2.0 Flash thinking、Llama 3.2和Gemma 3进行了测试。每个模型在确定性设置中回答每个问题三次,最终答案由多数投票确定。两名委员会认证的核医学医生独立提供参考答案,第三名专家解决分歧。我们以95%的置信区间计算总体准确率,并按题目类型、内容和考试年份进行亚组分析。结果:总体准确率为36.1% (Gemma 3) ~ 83.3% (ChatGPT 01 pro)。ChatGPTo1 pro得分最高(150/180,83.3% [95% CI: 77.1-88.5%]),其次是ChatGPT o3-mini(82.8%)和ChatGPTo1(78.9%)。所有模型在纯文本问题上的表现都比基于图像的问题好;ChatGPT 01 pro答对了89.5%的文字问题和66.0%的图片问题。VLMs在处理有关日本法规的问题方面显示出局限性。ChatGPT 4.5在神经学相关的基于图像的问题中表现出色(76.9%)。从2022年到2024年,大多数模型的准确率略低。结论:VLMs在JNMBE上表现出很高的准确性,特别是在基于文本的问题上,但在图像识别问题上表现出局限性。这些发现表明,vlm可以成为医学领域基于文本的问题的一个很好的助手,但当涉及到包括图像的综合问题时,它有局限性。目前,VLMs还不能取代全面的培训和专家解释。由于vlm发展迅速,考试难度每年都在变化,因此这些发现应该在此背景下解释。
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引用次数: 0
Kinetic and quantitative analysis of [18F]SMBT-1 PET imaging for monoamine oxidase B [18F]SMBT-1单胺氧化酶B PET显像动力学及定量分析。
IF 2.5 4区 医学 Q2 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING Pub Date : 2025-07-15 DOI: 10.1007/s12149-025-02083-y
Kotaro Hiraoka, Berihu Mesfin, Yingying Wu, Yuki Shimizu, Asuka Kikuchi, Ryuichi Harada, Aiko Ishiki, Yoshihito Funaki, Shozo Furumoto, Shunji Mugikura, Nobuyuki Okamura, Akio Kikuchi, Kazuhiko Yanai, Hiroyuki Arai, Hiroshi Watabe, Manabu Tashiro

Background and objective

In neuroinflammation, activated astrocytes, called reactive astrocytes, highly express monoamine oxidase B (MAO-B). [18F]SMBT-1 is a novel PET tracer developed for imaging neuroinflammation, with highly selective binding to MAO-B. The quantification method for [18F]SMBT-1 PET imaging has not been established, although some human studies using [18F]SMBT-1 PET imaging have already been conducted. In this study, we explored the most appropriate method for quantifying [18F]SMBT-1 PET.

Methods

Dynamic PET scanning of [18F]SMBT-1, accompanied by serial arterial blood sampling, was performed in healthy elderly subjects. With PET and blood data, the total distribution volumes (Vts) in the brain regions were calculated using a one-tissue compartment model (1TCM), a two-tissue compartment model (2TCM), and Logan graphical analysis. Standardized uptake values (SUVs) and SUV ratio-1 (SUVR-1) were determined for different time frames and reference regions.

Results

The values of the χ2 criterion and Akaike's Information Criterion (AIC) in the brain regions were lower in 2TCM than in 1TCM, suggesting that 2TCM was a better model in terms of curve fitting. However, the very high coefficient of variation (%COV) for parameters such as K1, k2, k3, and k4 in 2TCM suggests that these parameters may not have been properly estimated. SUVs, especially at 50–70 and 70–90 min post-injection, were strongly correlated with Vt (r = 0.9188–0.9445, p < 0.0001). SUVR-1 at these time points, referenced to various regions, showed significant correlations with MAO-B distribution in the brain shown in a previous postmortem study (r = 0.9362–0.9399, p < 0.0001).

Conclusions

These findings suggest that SUVR-1, especially at 50–70 min and 70–90 min post-injection, reflects MAO-B distribution and is useful for quantifying [18F]SMBT-1 PET imaging, potentially enabling noninvasive assessment of neuroinflammation in the brain.

Trial registration

Japan Registry of Clinical Trials (jRCT) (jRCTs021200019). It was registered on August 25, 2020. The jRCT was approved as a member of the Primary Registry Network of the WHO ICTRP.

背景和目的:在神经炎症中,活化的星形胶质细胞,称为反应性星形胶质细胞,高表达单胺氧化酶B (MAO-B)。[18F]SMBT-1是一种用于神经炎症成像的新型PET示踪剂,与MAO-B具有高选择性结合。[18F]SMBT-1 PET成像的定量方法尚未建立,尽管已经进行了一些使用[18F]SMBT-1 PET成像的人体研究。在本研究中,我们探索了最合适的定量方法[18F]SMBT-1 PET。方法:对健康老年人[18F]SMBT-1进行动态PET扫描,并进行连续动脉采血。结合PET和血液数据,采用单组织室模型(1TCM)、双组织室模型(2TCM)和Logan图形分析计算脑区总分布体积(Vts)。在不同时间框架和参考区域确定了标准化摄取值(SUV)和SUV比率-1 (SUVR-1)。结果:2中药组脑区χ2标准和赤池信息标准(Akaike’s Information criterion, AIC)值均低于1中药组,说明2中药在曲线拟合方面优于1中药组。然而,在2TCM中,K1、k2、k3和k4等参数的变异系数(%COV)非常高,这表明这些参数可能没有得到适当的估计。结论:这些发现表明,SUVR-1,特别是在注射后50-70分钟和70-90分钟,反映了MAO-B的分布,有助于量化[18F]SMBT-1 PET成像,有可能实现对大脑神经炎症的无创评估。试验注册:日本临床试验注册中心(jRCT) (jRCTs021200019)。它于2020年8月25日注册。jRCT被批准为世卫组织ICTRP初级注册网络的成员。
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引用次数: 0
Comparison of diagnostic performance between manual diagnosis following PROMISE V2 and aPROMISE utilizing Ga/F-PSMA PET/CT 使用Ga/F-PSMA PET/CT进行PROMISE V2人工诊断与aPROMISE诊断性能的比较。
IF 2.5 4区 医学 Q2 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING Pub Date : 2025-07-15 DOI: 10.1007/s12149-025-02086-9
Yuki Enei, Takafumi Yanagisawa, Atsuya Okada, Hidetoshi Kuruma, Chieko Okazaki, Ken Watanabe, Nat P. Lenzo, Takahiro Kimura, Kenta Miki

Backgrounds

Automated PROMISE (aPROMISE), which is an artificial intelligence-supported software for prostate-specific membrane antigen (PSMA) PET/CT based on PROMISE V2, has demonstrated diagnostic utility with better correspondence rates compared to manual diagnosis. However, previous studies have consistently utilized 18F-PSMA PET/CT. Therefore, we investigated the diagnostic utility of aPROMISE using both 18F- and 68 Ga-PSMA PET/CT of Japanese patients with metastatic prostate cancer (mPCa).

Materials and methods

We retrospectively evaluated 21 PSMA PET/CT images (68 Ga-PSMA PET/CT: n = 12, 18F-PSMA PET/CT: n = 9) from 21 patients with mPCa. A single, well-experienced nuclear radiologist performed manual diagnosis following PROMISE V2 and subsequently performed aPROMISE-assisted diagnosis to assess miTNM and details of metastatic sites. We compared the diagnostic time and correspondence rates of miTNM diagnosis between manual and aPROMISE-assisted diagnoses. Additionally, we investigated the differences in diagnostic performance between the two radioisotopes.

Results

aPROMISE-assisted diagnosis was significantly associated with shorter median diagnostic time compared to manual diagnosis (427 s [IQR: 370–834] vs. 1,114 s [IQR: 922–1291], p < 0.001). The time reduction with aPROMISE-assisted diagnosis was particularly notable when using 68 Ga-PSMA PET/CT. aPROMISE had high diagnostic accuracy with 100% sensitivity for miT, M1a, and M1b stages. Notably, for M1b stages, aPROMISE achieved 100% sensitivity and specificity, regardless of the type of radioisotope used. However, aPROMISE was misinterpreted in lymph node detection in some cases and missed five visceral metastases (2 adrenal and 3 liver), resulting in lower sensitivity for miM1c stage (63%). In addition to detecting metastatic sites, aPROMISE successfully provided detailed metrics, including the number of metastatic lesions, total metastatic volume, and SUV mean.

Conclusions

Despite the preliminary nature of the study, aPROMISE-assisted diagnosis significantly reduces diagnostic time and achieves satisfactory accuracy compared to manual diagnosis. While aPROMISE is effective in detecting bone metastases, its limitations in identifying lymph node and visceral metastases must be carefully addressed. This study supports the utility of aPROMISE in Japanese patients with mPCa and underscores the need for further validation in larger cohorts.

背景:Automated PROMISE (aPROMISE)是一款基于PROMISE V2的前列腺特异性膜抗原(PSMA) PET/CT的人工智能支持软件,与人工诊断相比,具有更好的符合率。然而,以前的研究一直使用18F-PSMA PET/CT。因此,我们使用18F-和68ga - psma PET/CT对日本转移性前列腺癌(mPCa)患者的诊断效用进行了研究。材料和方法:我们回顾性评估21例mPCa患者的21张PSMA PET/CT图像(68张Ga-PSMA PET/CT: n = 12, 18F-PSMA PET/CT: n = 9)。一位经验丰富的核放射科医生根据PROMISE V2进行手动诊断,随后进行PROMISE辅助诊断,以评估miTNM和转移部位的细节。我们比较了手工诊断和辅助诊断的miTNM诊断的诊断时间和对应率。此外,我们还研究了两种放射性同位素在诊断性能上的差异。结果:与手工诊断相比,promise辅助诊断的中位诊断时间更短(427秒[IQR: 370-834]对1,114秒[IQR: 922-1291], p 68 Ga-PSMA PET/CT)。aPROMISE对miT、M1a和M1b分期的诊断准确率高,灵敏度为100%。值得注意的是,对于M1b分期,无论使用何种放射性同位素,aPROMISE都实现了100%的灵敏度和特异性。然而,在一些病例中,aPROMISE在淋巴结检测中被误解,遗漏了5例内脏转移(2例肾上腺和3例肝脏),导致对miM1c分期的敏感性较低(63%)。除了检测转移部位外,aPROMISE还成功地提供了详细的指标,包括转移病灶数量、总转移体积和SUV平均值。结论:尽管这项研究是初步的,但与人工诊断相比,promise辅助诊断显着缩短了诊断时间,并达到了令人满意的准确性。虽然aPROMISE在检测骨转移方面是有效的,但它在识别淋巴结和内脏转移方面的局限性必须仔细解决。该研究支持aPROMISE在日本mPCa患者中的应用,并强调需要在更大的队列中进一步验证。
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引用次数: 0
PETFormer-SCL: a supervised contrastive learning-guided CNN–transformer hybrid network for Parkinsonism classification from FDG-PET PETFormer-SCL:一种基于FDG-PET的监督对比学习引导CNN-transformer混合网络用于帕金森分类。
IF 2.5 4区 医学 Q2 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING Pub Date : 2025-07-14 DOI: 10.1007/s12149-025-02081-0
Shaoyou Wu, Chenyang Li, Jiaying Lu, Jingjie Ge, Jing Wang, Chuantao Zuo, Zhilin Zhang, Jiehui Jiang

Purpose

Accurate differentiation of Parkinsonism subtypes—including Parkinson’s disease (PD), multiple system atrophy (MSA), and progressive supranuclear palsy (PSP)—is essential for clinical prognosis and treatment planning. However, this remains a major challenge due to overlapping symptomatology and high inter-individual variability in cerebral glucose metabolism patterns observed on fluorodeoxyglucose positron emission tomography (FDG-PET).

Methods

To address these challenges, we propose PETFormer-SCL, a clinically informed deep learning framework that integrates convolutional neural networks (CNNs) with a channel-wise Transformer module, guided by supervised contrastive learning (SCL). This architecture is designed to enhance disease-specific feature learning while mitigating individual variability.

Results

Trained on 945 patients and evaluated on an independent test cohort of 330 patients (1275 in total), PETFormer-SCL achieved AUCs of 0.9830, 0.9702, and 0.9565 for MSA, PD, and PSP, respectively. In addition, class activation maps (CAMs) highlighted key disease-related brain regions—including the cerebellum, midbrain, and basal ganglia—demonstrating strong alignment with known pathophysiological findings.

Conclusions

PETFormer-SCL not only achieves high diagnostic accuracy, particularly for subtypes with overlapping phenotypes, but also enhances interpretability. These results support its potential as a reliable clinical decision-support tool for the early and differential diagnosis of Parkinsonism.

目的:准确区分帕金森病亚型,包括帕金森病(PD)、多系统萎缩(MSA)和进行性核上性麻痹(PSP),对临床预后和治疗计划至关重要。然而,由于在氟脱氧葡萄糖正电子发射断层扫描(FDG-PET)上观察到的重叠症状和脑葡萄糖代谢模式的高度个体间差异,这仍然是一个主要挑战。方法:为了解决这些挑战,我们提出了PETFormer-SCL,这是一个临床知情的深度学习框架,在监督对比学习(SCL)的指导下,将卷积神经网络(cnn)与通道级Transformer模块集成在一起。该架构旨在增强疾病特定特征的学习,同时减轻个体差异。结果:PETFormer-SCL对945例患者进行了培训,并对330例患者(共1275例)进行了独立测试队列评估,MSA、PD和PSP的auc分别为0.9830、0.9702和0.9565。此外,类激活图(CAMs)突出了与疾病相关的关键大脑区域——包括小脑、中脑和基底神经节——显示出与已知病理生理学发现的强烈一致性。结论:PETFormer-SCL不仅具有较高的诊断准确性,特别是对于表型重叠的亚型,而且还增强了可解释性。这些结果支持其作为帕金森病早期和鉴别诊断可靠的临床决策支持工具的潜力。
{"title":"PETFormer-SCL: a supervised contrastive learning-guided CNN–transformer hybrid network for Parkinsonism classification from FDG-PET","authors":"Shaoyou Wu,&nbsp;Chenyang Li,&nbsp;Jiaying Lu,&nbsp;Jingjie Ge,&nbsp;Jing Wang,&nbsp;Chuantao Zuo,&nbsp;Zhilin Zhang,&nbsp;Jiehui Jiang","doi":"10.1007/s12149-025-02081-0","DOIUrl":"10.1007/s12149-025-02081-0","url":null,"abstract":"<div><h3>Purpose</h3><p>Accurate differentiation of Parkinsonism subtypes—including Parkinson’s disease (PD), multiple system atrophy (MSA), and progressive supranuclear palsy (PSP)—is essential for clinical prognosis and treatment planning. However, this remains a major challenge due to overlapping symptomatology and high inter-individual variability in cerebral glucose metabolism patterns observed on fluorodeoxyglucose positron emission tomography (FDG-PET).</p><h3>Methods</h3><p>To address these challenges, we propose PETFormer-SCL, a clinically informed deep learning framework that integrates convolutional neural networks (CNNs) with a channel-wise Transformer module, guided by supervised contrastive learning (SCL). This architecture is designed to enhance disease-specific feature learning while mitigating individual variability.</p><h3>Results</h3><p>Trained on 945 patients and evaluated on an independent test cohort of 330 patients (1275 in total), PETFormer-SCL achieved AUCs of 0.9830, 0.9702, and 0.9565 for MSA, PD, and PSP, respectively. In addition, class activation maps (CAMs) highlighted key disease-related brain regions—including the cerebellum, midbrain, and basal ganglia—demonstrating strong alignment with known pathophysiological findings.</p><h3>Conclusions</h3><p>PETFormer-SCL not only achieves high diagnostic accuracy, particularly for subtypes with overlapping phenotypes, but also enhances interpretability. These results support its potential as a reliable clinical decision-support tool for the early and differential diagnosis of Parkinsonism.</p></div>","PeriodicalId":8007,"journal":{"name":"Annals of Nuclear Medicine","volume":"39 11","pages":"1213 - 1227"},"PeriodicalIF":2.5,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Diagnostic accuracy of 18F-FDG and 68 Ga-FAPi PET/CT for patients with gastric carcinoma: a systematic review and meta-analysis 18F-FDG和68ga - fapi PET/CT对胃癌患者的诊断准确性:系统回顾和荟萃分析
IF 2.5 4区 医学 Q2 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING Pub Date : 2025-07-11 DOI: 10.1007/s12149-025-02082-z
Dikhra Khan, Jasim Jaleel, Ankita Phulia, Sambit Sagar, Prateek Kaushik, Rakesh Kumar

Objective

This systematic review aims to assess the diagnostic performance of FDG PET/CT and FAPi PET/CT in patients with gastric carcinoma, specifically for the evaluation of primary tumors, metastatic lymph nodes, and metastatic lesions.

Methods

Following PRISMA guidelines, relevant databases were searched until January 20, 2023. Studies reporting histopathology or surgical outcomes as the reference standard were included. Pooled estimates of diagnostic accuracy were generated using meta-analysis.

Results

Six studies with 167 patients who underwent FDG PET/CT and 169 patients who underwent FAPi PET/CT were included. For the detection of primary gastric carcinoma, FDG PET/CT demonstrated a pooled sensitivity of 0.86 (95% CI 0.47–0.98) and specificity of 0.70 (95% CI 0.39–0.90). The pooled positive likelihood ratio was 2.9 (95% CI 1.0–8.4), and the negative likelihood ratio was 0.21 (95% CI 0.03–1.30). The diagnostic odds ratio was 14 (95% CI 1–224), and the area under the SROC curve was 0.82. For FAPi PET/CT, pooled sensitivity and specificity for detecting primary gastric carcinoma were 0.90 (95% CI 0.90–0.90) and 0.50 (95% CI 0.50–0.50), respectively. The pooled positive and negative likelihood ratios were 1.8 (95% CI 1.8–1.8) and 0.20 (95% CI 0.20–0.20), respectively. The diagnostic odds ratio was 9 (95% CI 9–9), and the area under the SROC curve was 0.54.

Conclusion

FAPi PET/CT demonstrated comparable diagnostic performance to FDG PET/CT in the diagnosis of primary gastric carcinoma, lymph nodal metastases, and metastatic lesions. When compared to histopathology or surgical findings, FAPi PET/CT showed good sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio.

目的:本系统综述旨在评价FDG PET/CT和FAPi PET/CT对胃癌患者的诊断价值,特别是对原发肿瘤、转移淋巴结和转移灶的评估。方法:按照PRISMA指南,检索相关数据库至2023年1月20日。报告组织病理学或手术结果作为参考标准的研究被纳入。使用荟萃分析产生诊断准确性的汇总估计。结果:纳入6项研究,167例FDG PET/CT患者和169例FAPi PET/CT患者。对于原发性胃癌的检测,FDG PET/CT的敏感性为0.86 (95% CI 0.47-0.98),特异性为0.70 (95% CI 0.39-0.90)。合并阳性似然比为2.9 (95% CI 1.0-8.4),阴性似然比为0.21 (95% CI 0.03-1.30)。诊断优势比为14 (95% CI 1-224), SROC曲线下面积为0.82。FAPi PET/CT检测原发性胃癌的敏感性和特异性分别为0.90 (95% CI 0.90-0.90)和0.50 (95% CI 0.50-0.50)。合并阳性和阴性似然比分别为1.8 (95% CI 1.8-1.8)和0.20 (95% CI 0.20-0.20)。诊断优势比为9 (95% CI 9-9), SROC曲线下面积为0.54。结论:FAPi PET/CT与FDG PET/CT对原发性胃癌、淋巴结转移及转移灶的诊断性能相当。与组织病理学或手术结果相比,FAPi PET/CT表现出良好的敏感性、特异性、阳性似然比和阴性似然比。
{"title":"Diagnostic accuracy of 18F-FDG and 68 Ga-FAPi PET/CT for patients with gastric carcinoma: a systematic review and meta-analysis","authors":"Dikhra Khan,&nbsp;Jasim Jaleel,&nbsp;Ankita Phulia,&nbsp;Sambit Sagar,&nbsp;Prateek Kaushik,&nbsp;Rakesh Kumar","doi":"10.1007/s12149-025-02082-z","DOIUrl":"10.1007/s12149-025-02082-z","url":null,"abstract":"<div><h3>Objective</h3><p>This systematic review aims to assess the diagnostic performance of FDG PET/CT and FAPi PET/CT in patients with gastric carcinoma, specifically for the evaluation of primary tumors, metastatic lymph nodes, and metastatic lesions.</p><h3>Methods</h3><p>Following PRISMA guidelines, relevant databases were searched until January 20, 2023. Studies reporting histopathology or surgical outcomes as the reference standard were included. Pooled estimates of diagnostic accuracy were generated using meta-analysis.</p><h3>Results</h3><p>Six studies with 167 patients who underwent FDG PET/CT and 169 patients who underwent FAPi PET/CT were included. For the detection of primary gastric carcinoma, FDG PET/CT demonstrated a pooled sensitivity of 0.86 (95% CI 0.47–0.98) and specificity of 0.70 (95% CI 0.39–0.90). The pooled positive likelihood ratio was 2.9 (95% CI 1.0–8.4), and the negative likelihood ratio was 0.21 (95% CI 0.03–1.30). The diagnostic odds ratio was 14 (95% CI 1–224), and the area under the SROC curve was 0.82. For FAPi PET/CT, pooled sensitivity and specificity for detecting primary gastric carcinoma were 0.90 (95% CI 0.90–0.90) and 0.50 (95% CI 0.50–0.50), respectively. The pooled positive and negative likelihood ratios were 1.8 (95% CI 1.8–1.8) and 0.20 (95% CI 0.20–0.20), respectively. The diagnostic odds ratio was 9 (95% CI 9–9), and the area under the SROC curve was 0.54.</p><h3>Conclusion</h3><p>FAPi PET/CT demonstrated comparable diagnostic performance to FDG PET/CT in the diagnosis of primary gastric carcinoma, lymph nodal metastases, and metastatic lesions. When compared to histopathology or surgical findings, FAPi PET/CT showed good sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio.</p></div>","PeriodicalId":8007,"journal":{"name":"Annals of Nuclear Medicine","volume":"39 11","pages":"1228 - 1236"},"PeriodicalIF":2.5,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144607217","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pharmacokinetics and dosimetry of [177Lu]Lu-PSMA-617 and [68Ga]Ga-PSMA-11 in Japanese patients with PSMA-positive mCRPC [177Lu]Lu-PSMA-617和[68Ga]Ga-PSMA-11在日本psma阳性mCRPC患者中的药代动力学和剂量学
IF 2.5 4区 医学 Q2 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING Pub Date : 2025-07-10 DOI: 10.1007/s12149-025-02079-8
Shoko Takano, Anri Inaki, Kenji Hirata, Richard B. Sparks, Masahiko Sato, Satoshi Nomura, Toru Hattori, Hiroya Kambara, Quyen Nguyen, Tohru Shiga, Seigo Kinuya, Makoto Hosono
<div><h3>Objective</h3><p>This prospective, open-label, single-arm, phase 2 study evaluated the efficacy, safety, pharmacokinetics (PK) and dosimetry of [<sup>177</sup>Lu]Lu-PSMA-617 in Japanese patients with progressive PSMA+ mCRPC.</p><h3>Methods</h3><p>This is a PK/dosimetry analysis of [<sup>68</sup>Ga]Ga-PSMA-11 and [<sup>177</sup>Lu]Lu-PSMA-617 in patients from Parts 1, 2, and 3 of the 4-part study. Blood and urine samples, serial PET/CT, planar, and SPECT/CT scans were collected post-administration of [<sup>68</sup>Ga]Ga-PSMA-11 (111–259 MBq) at screening and [<sup>177</sup>Lu]Lu-PSMA-617 (7.4 GBq ± 10%) during cycle 1. External radiation exposure in medical personnel and family members was measured once in each cycle from cycle 1 to 6, excluding the cycle where dosimetry was performed.</p><h3>Results</h3><p>Of 35 patients included, 3 patients each had evaluable data for PK/dosimetry of [<sup>68</sup>Ga]Ga-PSMA-11 and [<sup>177</sup>Lu]Lu-PSMA-617. Both [<sup>68</sup>Ga]Ga-PSMA-11 and [<sup>177</sup>Lu]Lu-PSMA-617 showed a bi-exponential decline in blood concentrations post-dosage, with an initial rapid phase followed by a slower phase. For [<sup>68</sup>Ga]Ga-PSMA-11, terminal half-life (T<sub>1/2</sub>; geometric mean) was 3.93 h, total systemic clearance (CL) was 5.52 L/hr, and an apparent volume of distribution (V<sub>z</sub>) was 31.3 L. For [<sup>177</sup>Lu]Lu-PSMA-617, these values were 28.9 h, 1.71 L/hr, and 71.2 L, respectively. For [<sup>68</sup>Ga]Ga-PSMA-11 dosimetry, kidneys received the largest absorbed doses (0.23 ± 0.14 mGy/MBq), and effective dose was 0.030 mSv/MBq. For a full six-cycle cumulative injected activity of 44.4 GBq of [<sup>177</sup>Lu]Lu-PSMA-617, the lacrimal glands received the largest estimated absorbed dose of 90 ± 45 Gy. The mean absorbed dose to the kidneys (critical organ) was 0.34 Gy/GBq, resulting in a cumulative absorbed dose of 15 Gy for the full six-cycles. The radiation exposure was evaluated among 13 medical personnel, 8 who participated in administration, and family members. Measurements were taken at 8 sites including patients’ home. External radiation exposure to medical personnel and family members was minimal, with 0 μSv in 6/7 patients and 60 μSv in 1 patient.</p><h3>Conclusion</h3><p>This is the first prospective Japanese study to demonstrate the use of [<sup>68</sup>Ga]Ga-PSMA-11 and [<sup>177</sup>Lu]Lu-PSMA-617 in patients with mCRPC. The absorbed doses in various organs for both radiopharmaceuticals were consistent with previously reported data. Minimal radiation exposure observed for medical personnel and caregivers highlights the safety of [<sup>177</sup>Lu]Lu-PSMA-617 during treatment, ensuring a secure treatment environment.</p><h3>Trial registration</h3><p>This study is a prospective, open-label, multicenter, single-arm, phase 2 trial of [<sup>177</sup>Lu]Lu-PSMA-617 in patients with progressive PSMA + mCRPC in Japan (NCT05114746). The trial was initiated on 25-Jan-2022 (first pa
目的:这项前瞻性、开放标签、单臂、2期研究评估了[177Lu]Lu-PSMA-617在日本进行性PSMA+ mCRPC患者中的疗效、安全性、药代动力学(PK)和剂量学。方法:这是在4部分研究的第1、2和3部分患者中对[68Ga]Ga-PSMA-11和[177Lu]Lu-PSMA-617进行PK/剂量学分析。在筛选时给予[68Ga]Ga-PSMA-11 (111-259 MBq),在第1周期给予[177Lu]Lu-PSMA-617 (7.4 GBq±10%)后,收集血液和尿液样本、连续PET/CT、平面和SPECT/CT扫描。从第1周期至第6周期,每个周期测量一次医务人员和家庭成员的外部辐射暴露,不包括进行剂量测定的周期。结果:纳入的35例患者中,3例患者的PK/剂量学数据均可评估[68Ga]Ga-PSMA-11和[177Lu]Lu-PSMA-617。[68Ga]Ga-PSMA-11和[177Lu]Lu-PSMA-617给药后血药浓度均呈双指数下降,先呈快速期,后呈缓慢期。对于[68Ga]Ga-PSMA-11,终端半衰期(T1/2;几何平均)为3.93 h,总系统清除率(CL)为5.52 L/hr,表观分布容积(Vz)为31.3 L, [177Lu] lu - pma -617的这些值分别为28.9 h、1.71 L/hr和71.2 L。[68Ga]Ga-PSMA-11剂量法中,肾脏吸收剂量最大(0.23±0.14 mGy/MBq),有效剂量为0.030 mSv/MBq。对于6个周期44.4 GBq的[177Lu]Lu-PSMA-617的累计注射活性,泪腺接受的最大估计吸收剂量为90±45 Gy。肾脏(关键器官)的平均吸收剂量为0.34戈瑞/GBq,导致整个6个周期的累积吸收剂量为15戈瑞。对13名医务人员、8名参与给药人员和家属进行了辐射暴露评估。在包括患者家在内的8个地点进行了测量。医务人员和家属的外部辐射暴露最小,6/7例患者为0 μSv, 1例患者为60 μSv。结论:这是日本首个证明在mCRPC患者中使用[68Ga]Ga-PSMA-11和[177Lu]Lu-PSMA-617的前瞻性研究。两种放射性药物在不同器官中的吸收剂量与以前报告的数据一致。医务人员和护理人员观察到的最小辐射暴露强调了[177Lu]Lu-PSMA-617在治疗期间的安全性,确保了安全的治疗环境。试验注册:该研究是一项前瞻性、开放标签、多中心、单臂、2期临床试验,在日本进展性PSMA + mCRPC患者中使用[177Lu]Lu-PSMA-617 (NCT05114746)。该试验于2022年1月25日启动(首次患者首次就诊),主要分析数据截止日期为2023年12月8日。这项研究仍在进行中。共有35名患者被筛选并接受了[68Ga]Ga-PSMA-11,其中30名患者被纳入[177Lu]Lu-PSMA617的疗效和安全性评估,包括第1部分(安全性试验)、第2部分(紫杉烷后)和第3部分(紫杉烷前)。此外,3例患者均有可评估的[68Ga]Ga-PSMA-11和[177Lu]Lu-PSMA-617的PK和剂量学评估数据。在进行任何研究特定程序之前,获得所有参与者的知情同意。
{"title":"Pharmacokinetics and dosimetry of [177Lu]Lu-PSMA-617 and [68Ga]Ga-PSMA-11 in Japanese patients with PSMA-positive mCRPC","authors":"Shoko Takano,&nbsp;Anri Inaki,&nbsp;Kenji Hirata,&nbsp;Richard B. Sparks,&nbsp;Masahiko Sato,&nbsp;Satoshi Nomura,&nbsp;Toru Hattori,&nbsp;Hiroya Kambara,&nbsp;Quyen Nguyen,&nbsp;Tohru Shiga,&nbsp;Seigo Kinuya,&nbsp;Makoto Hosono","doi":"10.1007/s12149-025-02079-8","DOIUrl":"10.1007/s12149-025-02079-8","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objective&lt;/h3&gt;&lt;p&gt;This prospective, open-label, single-arm, phase 2 study evaluated the efficacy, safety, pharmacokinetics (PK) and dosimetry of [&lt;sup&gt;177&lt;/sup&gt;Lu]Lu-PSMA-617 in Japanese patients with progressive PSMA+ mCRPC.&lt;/p&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;p&gt;This is a PK/dosimetry analysis of [&lt;sup&gt;68&lt;/sup&gt;Ga]Ga-PSMA-11 and [&lt;sup&gt;177&lt;/sup&gt;Lu]Lu-PSMA-617 in patients from Parts 1, 2, and 3 of the 4-part study. Blood and urine samples, serial PET/CT, planar, and SPECT/CT scans were collected post-administration of [&lt;sup&gt;68&lt;/sup&gt;Ga]Ga-PSMA-11 (111–259 MBq) at screening and [&lt;sup&gt;177&lt;/sup&gt;Lu]Lu-PSMA-617 (7.4 GBq ± 10%) during cycle 1. External radiation exposure in medical personnel and family members was measured once in each cycle from cycle 1 to 6, excluding the cycle where dosimetry was performed.&lt;/p&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;p&gt;Of 35 patients included, 3 patients each had evaluable data for PK/dosimetry of [&lt;sup&gt;68&lt;/sup&gt;Ga]Ga-PSMA-11 and [&lt;sup&gt;177&lt;/sup&gt;Lu]Lu-PSMA-617. Both [&lt;sup&gt;68&lt;/sup&gt;Ga]Ga-PSMA-11 and [&lt;sup&gt;177&lt;/sup&gt;Lu]Lu-PSMA-617 showed a bi-exponential decline in blood concentrations post-dosage, with an initial rapid phase followed by a slower phase. For [&lt;sup&gt;68&lt;/sup&gt;Ga]Ga-PSMA-11, terminal half-life (T&lt;sub&gt;1/2&lt;/sub&gt;; geometric mean) was 3.93 h, total systemic clearance (CL) was 5.52 L/hr, and an apparent volume of distribution (V&lt;sub&gt;z&lt;/sub&gt;) was 31.3 L. For [&lt;sup&gt;177&lt;/sup&gt;Lu]Lu-PSMA-617, these values were 28.9 h, 1.71 L/hr, and 71.2 L, respectively. For [&lt;sup&gt;68&lt;/sup&gt;Ga]Ga-PSMA-11 dosimetry, kidneys received the largest absorbed doses (0.23 ± 0.14 mGy/MBq), and effective dose was 0.030 mSv/MBq. For a full six-cycle cumulative injected activity of 44.4 GBq of [&lt;sup&gt;177&lt;/sup&gt;Lu]Lu-PSMA-617, the lacrimal glands received the largest estimated absorbed dose of 90 ± 45 Gy. The mean absorbed dose to the kidneys (critical organ) was 0.34 Gy/GBq, resulting in a cumulative absorbed dose of 15 Gy for the full six-cycles. The radiation exposure was evaluated among 13 medical personnel, 8 who participated in administration, and family members. Measurements were taken at 8 sites including patients’ home. External radiation exposure to medical personnel and family members was minimal, with 0 μSv in 6/7 patients and 60 μSv in 1 patient.&lt;/p&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;p&gt;This is the first prospective Japanese study to demonstrate the use of [&lt;sup&gt;68&lt;/sup&gt;Ga]Ga-PSMA-11 and [&lt;sup&gt;177&lt;/sup&gt;Lu]Lu-PSMA-617 in patients with mCRPC. The absorbed doses in various organs for both radiopharmaceuticals were consistent with previously reported data. Minimal radiation exposure observed for medical personnel and caregivers highlights the safety of [&lt;sup&gt;177&lt;/sup&gt;Lu]Lu-PSMA-617 during treatment, ensuring a secure treatment environment.&lt;/p&gt;&lt;h3&gt;Trial registration&lt;/h3&gt;&lt;p&gt;This study is a prospective, open-label, multicenter, single-arm, phase 2 trial of [&lt;sup&gt;177&lt;/sup&gt;Lu]Lu-PSMA-617 in patients with progressive PSMA + mCRPC in Japan (NCT05114746). The trial was initiated on 25-Jan-2022 (first pa","PeriodicalId":8007,"journal":{"name":"Annals of Nuclear Medicine","volume":"39 11","pages":"1201 - 1212"},"PeriodicalIF":2.5,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12149-025-02079-8.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144599193","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Annals of Nuclear Medicine
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