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Biodistribution and first clinical results of 18F-SiFAlin-TATE PET: a novel 18F-labeled somatostatin analog for imaging of neuroendocrine tumors.
European Journal of Nuclear Medicine and Molecular Imaging ( IF 9.1 ) Pub Date : null , DOI: 10.1007/s00259-019-04501-6
Harun Ilhan 1, 2 , S Lindner 1 , A Todica 1, 2 , C C Cyran 3 , R Tiling 1 , C J Auernhammer 2, 4 , C Spitzweg 2, 4 , S Boeck 2, 5 , M Unterrainer 1 , F J Gildehaus 1 , G Böning 1 , K Jurkschat 6 , C Wängler 7 , B Wängler 8 , R Schirrmacher 9 , P Bartenstein 1, 2
Affiliation  

INTRODUCTION PET/CT using 68Ga-labeled somatostatin analogs (SSA) targeting somatostatin receptors (SSR) on the cell surface of well-differentiated neuroendocrine tumors (NET) represents the clinical reference standard for imaging. However, economic and logistic challenges of the 68Ge/68Ga generator-based approach have disadvantages over 18F-labeled compounds. Here, we present the first in-human data of 18F-SiFAlin-TATE, a novel 18F-labeled, SSR-targeting peptide. The aim was to compare the intra-individual biodistribution, tumor uptake, and image quality of 18F-SiFAlin-TATE to the clinical reference standard 68Ga-DOTA-TOC. METHODS Thirteen patients with NET staged with both 68Ga-DOTA-TOC and 18F-SiFAlin-TATE PET/CT have been included in this retrospective analysis. We compared the biodistribution in normal organs and tumor uptake of NET lesions by SUVmean and SUVmax measurement for tracers. Additionally mean and max tumor-to-liver (TLR) and tumor-to-spleen ratios (TSR) have been calculated by division of SUVmean and SUVmax of tumor lesions by the SUVmean of the liver and spleen, respectively. Additionally, image quality was visually rated by 5 blinded readers and an intra-class correlation (ICC) analysis on inter-observer agreement has been performed. RESULTS Compared with 68Ga-DOTA-TOC, the biodistribution of 18F-SiFAlin-TATE showed somewhat higher, however, statistically not significant higher uptake in the liver, spleen, and adrenal glands. Significantly higher uptake was observed in the kidneys. Tumor uptake was higher in most tumor lesions with significantly higher uptake in common metastatic sites of NET including the liver (SUVmax 18.8 ± 8.4 vs. 12.8 ± 5.6; p < 0.001), lymph nodes (SUVmax 23.8 ± 20.7 vs. 17.4 ± 16.1; p < 0.001) and bone (SUVmax 16.0 ± 10.1 vs. 10.3 ± 5.7; p < 0.01) for 18F-SiFAlin-TATE. The high tumor uptake resulted in favorable TLR and TSR, comparable with that of 68Ga-DOTA-TOC. The ICC analysis on the inter-observer agreement on image quality was substantial and almost perfect. Image quality was rated as excellent in most cases in both 68Ga-DOTA-TOC and 18F-SiFAlin-TATE PET. CONCLUSION The favorable characteristics of 18F-SiFAlin-TATE with a high image quality, the kit-like labeling procedure, and the promising clinical performance enable improved logistics and diagnostic possibilities for PET imaging of NET. Our first clinical results warrant further systematic studies investigating the clinical use of 18F-SiFAlin-TATE in NET patients.

中文翻译:

18F-SiFAlin-TATE PET的生物分布和首次临床结果:一种用于神经内分泌肿瘤成像的新型18F标记生长抑素类似物。

简介PET / CT使用在分化良好的神经内分泌肿瘤(NET)细胞表面上靶向生长抑素受体(SSR)的68Ga标记的生长抑素类似物(SSA)代表了成像的临床参考标准。但是,与基于18F标记的化合物相比,基于68Ge / 68Ga发生器的方法在经济和后勤方面的挑战具有劣势。在这里,我们介绍了18F-SiFAlin-TATE(一种新型的18F标记,SSR靶向肽)的第一个人类数据。目的是将18F-SiFAlin-TATE与临床参考标准68Ga-DOTA-TOC的个体内生物分布,肿瘤吸收和图像质量进行比较。方法回顾性分析了13例同时用68Ga-DOTA-TOC和18F-SiFAlin-TATE PET / CT进行的NET患者。我们比较了通过SUVmean和SUVmax测量示踪剂在正常器官中的生物分布和NET病变的肿瘤吸收。另外,分别通过将肿瘤病变的SUVmean和SUVmax除以肝脏和脾脏的SUVmean来计算平均和最大肿瘤-肝脏(TLR)和肿瘤-脾脏比(TSR)。此外,对5位盲人阅读者的图像质量进行了视觉评估,并且对观察者之间的一致性进行了类内相关(ICC)分析。结果与68Ga-DOTA-TOC相比,18F-SiFAlin-TATE的生物分布显示出较高的生物分布,但是从统计学上看,肝脏,脾脏和肾上腺的摄取没有显着增加。在肾脏中观察到明显更高的摄取。在大多数肿瘤病灶中,肿瘤吸收较高,在包括肝在内的NET常见转移部位的吸收明显更高(SUVmax 18.8±8.4对12.8±5.6; p <0.001),淋巴结(SUVmax 23.8±20.7对17.4±16.1; p <0.001)和18F-SiFAlin-TATE的骨骼(SUVmax 16.0±10.1与10.3±5.7; p <0.01)。与68Ga-DOTA-TOC相比,高肿瘤摄取导致有利的TLR和TSR。ICC对观察者之间关于图像质量的协议的分析是实质性的,并且几乎是完美的。在大多数情况下,无论是68Ga-DOTA-TOC还是18F-SiFAlin-TATE PET,图像质量均被评为出色。结论18F-SiFAlin-TATE的良好特性具有高图像质量,类似于试剂盒的标记程序,良好的临床表现为NET的PET成像提供了改善的后勤和诊断可能性。我们的第一批临床结果值得进一步系统研究,以研究NET患者中18F-SiFAlin-TATE的临床应用。
更新日期:2020-03-19
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