Diagnostic Performance and Safety of Positron Emission Tomography Using 18F-Fluciclovine in Patients with Clinically Suspected High- or Low-grade Gliomas: A Multicenter Phase IIb Trial.
Diagnostic Performance and Safety of Positron Emission Tomography Using 18F-Fluciclovine in Patients with Clinically Suspected High- or Low-grade Gliomas: A Multicenter Phase IIb Trial.
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DOI：
10.22038/aojnmb.2016.7869
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发表时间：
2017-01-01
影响因子：
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通讯作者：
Kubomura, Kan
中科院分区：
文献类型：
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作者：
Wakabayashi, Toshihiko;Iuchi, Toshihiko;Kubomura, Kan
目的：本研究目的是评估使用新型示踪剂18F-氟氯梵（anti-[18F]FACBC）的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例临床怀疑为高或低级别胶质瘤的患者进行抗[18F]FACBC治疗，并进行PET成像。获得t1加权、对比增强t1加权和流体衰减反转恢复（或t2加权）磁共振成像（MRI）扫描，以计划组织收集。从“使用抗[18F]FACBC PET成像显示但未使用对比增强t1加权成像的区域”或“使用抗[18F]FACBC-PET成像和对比增强t1加权成像显示的区域”收集组织，进行组织病理学检查，以评估抗[18F]FACBC-PET对胶质瘤的诊断准确性。结果：抗[18F]FACBC-PET成像对使用抗[18F]FACBC-PET成像而未使用对比增强t1 -加权成像的区域的胶质瘤阳性预测值为100.0%(26/26)，同时使用对比增强t1 -加权成像和抗[18F]FACBC-PET成像的区域的阳性预测值为87.5%（7/8）。在接受抗[18F]FACBC治疗的40例患者中，有7例（17.5%）发生了12例不良事件。5例患者中有5例事件被认为是药物不良反应；然而，没有一个事件是严重的，除了一个之外，所有的事件都是自发的，无需治疗。结论：这项IIb期试验表明，anti-[18F]FACBC-PET成像可有效检测对比增强t1加权MRI无法显示的区域的胶质瘤，且示踪剂耐受性良好。
OBJECTIVES: The study objective was to assess the diagnostic performance of positron emission tomography (PET) for gliomas using the novel tracer 18F-fluciclovine (anti-[18F]FACBC) and to evaluate the safety of this tracer in patients with clinically suspected gliomas.METHODS: Anti-[18F]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-[18F]FACBC PET imaging but not using contrast-enhanced T1-weighted imaging" or "areas visualized using both anti-[18F]FACBC-PET imaging and contrast-enhanced T1-weighted imaging" and were histopathologically examined to assess the diagnostic accuracy of anti-[18F]FACBC-PET for gliomas.RESULTS: The positive predictive value of anti-[18F]FACBC-PET imaging for glioma in areas visualized using anti-[18F]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-[18F]FACBC-PET imaging was 87.5% (7/8). Twelve adverse events occurred in 7 (17.5%) of the 40 patients who received anti-[18F]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-[18F]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.