A preliminary clinical trial to evaluate (64)Cu-NOTA-Trastuzumab as a positron emission tomography imaging agent in patients with breast cancer.
A preliminary clinical trial to evaluate (64)Cu-NOTA-Trastuzumab as a positron emission tomography imaging agent in patients with breast cancer.
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DOI：
10.1186/s13550-021-00746-1
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发表时间：
2021-01-21
期刊：
影响因子：
3.2
通讯作者：
Lim SM
中科院分区：
文献类型：
--
作者：
Lee I;Lim I;Byun BH;Kim BI;Choi CW;Woo SK;Kim KI;Lee KC;Kang JH;Seong MK;Kim HA;Noh WC;Lim SM
本研究的目的是评价64 Cu-1，4，7-三氮杂环壬烷-1，4，7-三乙酸（NOTA）-曲妥珠单抗（一种新型64 Cu标记的人表皮生长因子受体2（HER 2）正电子发射断层扫描（PET）示踪剂）在乳腺癌患者中的生物分布和安全性。 从7名乳腺癌患者中获得了注射296 MBq 64 Cu-NOTA-曲妥珠单抗后1、24和48 h的PET图像。评价原发灶和转移灶的最大标准摄取值（SUVmax）。在其他器官中评价平均SUVmax（SUVmean），包括血池、肝脏、肾脏、肌肉、脾脏、膀胱和肺以及骨骼。此外，使用OLINDA/EXM软件计算内辐射剂量。基于64 Cu-NOTA-曲妥珠单抗给药后1个月内关于不良反应和安全性相关问题的反馈，评估安全性。64 Cu-NOTA-曲妥珠单抗PET图像显示，各器官的总体SUV均值与时间呈负相关。注射后1 h、24 h和48 h，肝脏的平均SUV均值分别为5.3 ± 0.7、4.8 ± 0.6和4.4 ± 0.5。注射后1 h、24 h和48 h，测量的平均SUV平均血液值分别为13.1 ± 0.9、9.1 ± 1.2和7.1 ± 1.9。HER 2阳性肿瘤的SUVmax相对高于HER 2阴性肿瘤（注射后48小时分别为8.6 ± 5.1和5.2 ± 2.8）。HER 2阳性肿瘤的肿瘤背景比高于HER 2阴性肿瘤。未报告与64 Cu-NOTA-曲妥珠单抗相关的不良事件。296 MBq注射64 Cu-NOTA-曲妥珠单抗的计算有效剂量为2.96 mSv。肝脏吸收剂量最高（0.076 mGy/MBq），其次是脾脏（0.063 mGy/MBq）、肾脏（0.044 mGy/MBq）和心脏壁（0.044 mGy/MBq）。64 Cu-NOTA-Trastuzumab在表达HER 2的肿瘤中显示出特异性摄取，因此使其成为乳腺癌患者中HER 2肿瘤状态的可行且安全的监测工具。CRIS，KCT0002790。2018年2月2日注册，https://cris.nih.go.kr
The purpose of this study was to evaluate both the biodistribution and safety of 64Cu-1,4,7-triazacyclononane-1,4,7-triacetic acid (NOTA)-Trastuzumab, a novel 64Cu-labeled positron emission tomography (PET) tracer for human epidermal growth factor receptor 2 (HER2) in patients with breast cancer. PET images at 1, 24, and 48 h after 296 MBq of 64Cu-NOTA-Trastuzumab injection were obtained from seven patients with breast cancer. Both the primary tumors’ and metastatic lesions’ maximum standardized uptake value (SUVmax) was evaluated. The mean SUVmax (SUVmean) was evaluated in the other organs, including the blood pool, liver, kidney, muscle, spleen, bladder, and the lungs, as well as the bones. Moreover, the internal radiation dosimetry was calculated using the OLINDA/EXM software. Safety was assessed based on feedback regarding adverse reactions and safety-related issues within 1 month after 64Cu-NOTA-Trastuzumab administration. 64Cu-NOTA-Trastuzumab PET images showed that the overall SUVmean values in each organ negatively correlated with time. The liver’s average SUVmean values were measured at 5.3 ± 0.7, 4.8 ± 0.6, and 4.4 ± 0.5 on 1 h, 24 h, and 48 h after injection, respectively. The average SUVmean blood values were measured at 13.1 ± 0.9, 9.1 ± 1.2, and 7.1 ± 1.9 on 1 h, 24 h, and 48 h after injection, respectively. The SUVmax of HER2-positive tumors was relatively higher than HER2-negative tumors (8.6 ± 5.1 and 5.2 ± 2.8 on 48 h after injection, respectively). Tumor-to-background ratios were higher in the HER2-positive tumors than in the HER2-negative tumors. No adverse events related to 64Cu-NOTA-Trastuzumab were reported. The calculated effective dose with a 296 MBq injection of 64Cu-NOTA-Trastuzumab was 2.96 mSv. The highest absorbed dose was observed in the liver (0.076 mGy/MBq), followed by the spleen (0.063 mGy/MBq), kidney (0.044 mGy/MBq), and heart wall (0.044 mGy/MBq). 64Cu-NOTA-Trastuzumab showed a specific uptake at the HER2-expressing tumors, thus making it a feasible and safe monitoring tool of HER2 tumor status in patients with breast cancer. CRIS, KCT0002790. Registered 02 February 2018, https://cris.nih.go.kr
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影响因子：
3.1
作者：
Dearling JL;Voss SD;Dunning P;Snay E;Fahey F;Smith SV;Huston JS;Meares CF;Treves ST;Packard AB
通讯作者：
Packard AB
特异性分子成像在HER2阳性乳腺癌中的临床前和临床应用。
影响因子：
5.5
作者：
Chen W;Li X;Zhu L;Liu J;Xu W;Wang P
通讯作者：
Wang P
影响因子：
3.2
作者：
Kurihara H;Hamada A;Yoshida M;Shimma S;Hashimoto J;Yonemori K;Tani H;Miyakita Y;Kanayama Y;Wada Y;Kodaira M;Yunokawa M;Yamamoto H;Shimizu C;Takahashi K;Watanabe Y;Fujiwara Y;Tamura K
通讯作者：
Tamura K
影响因子：
2.8
作者：
Gaykema, Sietske B. M.;de Jong, Johan R.;Lub-de Hooge, Marjolijn N.
通讯作者：
Lub-de Hooge, Marjolijn N.
影响因子：
3.1
作者：
De Silva, Ravindra A.;Jain, Sandeep;Rogers, Buck E.
通讯作者：
Rogers, Buck E.