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使用F-氟代脱氧胸苷的正电子发射断层扫描在临床疑似高级或低级胶质瘤患者中的诊断性能和安全性：一项多中心IIb期试验

Diagnostic Performance and Safety of Positron Emission Tomography Using F-Fluciclovine in Patients with Clinically Suspected High- or Low-grade Gliomas: A Multicenter Phase IIb Trial.

作者信息

Wakabayashi Toshihiko, Iuchi Toshihiko, Tsuyuguchi Naohiro, Nishikawa Ryo, Arakawa Yoshiki, Sasayama Takashi, Miyake Keisuke, Nariai Tadashi, Narita Yoshitaka, Hashimoto Naoya, Okuda Osamu, Matsuda Hiroshi, Kubota Kazuo, Ito Kimiteru, Nakazato Yoichi, Kubomura Kan

机构信息

Department of Neurosurgery, Nagoya University, Graduate School of Medicine, Aichi, Japan.

Division of Neurological Surgery, Chiba Cancer Center, Chiba, Japan.

出版信息

Asia Ocean J Nucl Med Biol. 2017 Winter;5(1):10-21. doi: 10.22038/aojnmb.2016.7869.

DOI:10.22038/aojnmb.2016.7869
PMID:28840134
原文链接:
https://pmc.ncbi.nlm.nih.gov/articles/PMC5221680/
Abstract

OBJECTIVES

The study objective was to assess the diagnostic performance of positron emission tomography (PET) for gliomas using the novel tracer F-fluciclovine (anti-[F]FACBC) and to evaluate the safety of this tracer in patients with clinically suspected gliomas.

METHODS

Anti-[F]FACBC was administered to 40 patients with clinically suspected high- or low-grade gliomas, followed by PET imaging. T1-weighted, contrast-enhanced T1-weighted, and fluid-attenuated inversion recovery (or T2-weighted) magnetic resonance imaging (MRI) scans were obtained to plan for the tissue collection. Tissues were collected from either "areas visualized using anti-[F]FACBC PET imaging but not using contrast-enhanced T1-weighted imaging" or "areas visualized using both anti-[F]FACBC-PET imaging and contrast-enhanced T1-weighted imaging" and were histopathologically examined to assess the diagnostic accuracy of anti-[F]FACBC-PET for gliomas.

RESULTS

The positive predictive value of anti-[F]FACBC-PET imaging for glioma in areas visualized using anti-[F]FACBC-PET imaging, but not visualized using contrast-enhanced T1-weighted images, was 100.0% (26/26), and the value in areas visualized using both contrast-enhanced T1-weighted imaging and anti-[F]FACBC-PET imaging was 87.5% (7/8). Twelve adverse events occurred in 7 (17.5%) of the 40 patients who received anti-[F]FACBC. Five events in five patients were considered to be adverse drug reactions; however, none of the events were serious, and all except one resolved spontaneously without treatment.

CONCLUSION

This Phase IIb trial showed that anti-[F]FACBC-PET imaging was effective for the detection of gliomas in areas not visualized using contrast-enhanced T1-weighted MRI and the tracer was well tolerated.

摘要

目的

本研究的目的是使用新型示踪剂F-氟代氯乙氧苯胺（抗-[F]FACBC）评估正电子发射断层扫描（PET）对胶质瘤的诊断性能，并评估该示踪剂在临床疑似胶质瘤患者中的安全性。

方法

对40例临床疑似高级别或低级别胶质瘤患者给予抗-[F]FACBC，随后进行PET成像。获取T1加权、对比增强T1加权和液体衰减反转恢复（或T2加权）磁共振成像（MRI）扫描以计划组织采集。组织取自“使用抗-[F]FACBC PET成像可见但使用对比增强T1加权成像不可见的区域”或“使用抗-[F]FACBC-PET成像和对比增强T1加权成像均可见的区域”，并进行组织病理学检查以评估抗-[F]FACBC-PET对胶质瘤的诊断准确性。

结果

在使用抗-[F]FACBC-PET成像可见但使用对比增强T1加权图像不可见的区域，抗-[F]FACBC-PET成像对胶质瘤的阳性预测值为100.0%（26/26），在使用对比增强T1加权成像和抗-[F]FACBC-PET成像均可见的区域，该值为87.5%（7/8）。40例接受抗-[F]FACBC治疗的患者中有7例（17.5%）发生了12起不良事件。5例患者的5起事件被认为是药物不良反应；然而，所有事件均不严重，除1例以外均未经治疗自发缓解。

结论

这项IIb期试验表明，抗-[F]FACBC-PET成像在使用对比增强T1加权MRI不可见的区域检测胶质瘤有效，且该示踪剂耐受性良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d51/5221680/25064a8fbe60/AOJNMB-5-10-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d51/5221680/72daadce0f5d/AOJNMB-5-10-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d51/5221680/5d690547b9cd/AOJNMB-5-10-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d51/5221680/17aff05c9dff/AOJNMB-5-10-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d51/5221680/25064a8fbe60/AOJNMB-5-10-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d51/5221680/72daadce0f5d/AOJNMB-5-10-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d51/5221680/5d690547b9cd/AOJNMB-5-10-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d51/5221680/17aff05c9dff/AOJNMB-5-10-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d51/5221680/25064a8fbe60/AOJNMB-5-10-g004.jpg

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