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

Document Type : Original Article


1 Department of Neurosurgery, Nagoya University, Graduate School of Medicine

2 Division of Neurological Surgery, Chiba Cancer Center

3 Department of Neurosurgery, Osaka City University Graduate School of Medicine

4 Department of Neuro-Oncology/Neurosurgery, Saitama International Medical Center, Saitama Medical University

5 Department of Neurosurgery, Kyoto University Graduate School of Medicine

6 Department of Neurosurgery, Kobe University Graduate School of Medicine

7 Department of Neurological Surgery, Faculty of Medicine, Kagawa University

8 Department of Neurosurgery, Tokyo Medical and Dental University

9 Department of Neurosurgery and Neuro-Oncology, National Cancer Center Hospital

10 Department of Neurosurgery, Osaka University Graduate School of Medicine

11 Department of Neurosurgery, Juntendo Tokyo Koto Geriatric Medical Center

12 Integrative Brain Imaging Center, National Center of Neurology and Psychiatry

13 Division of Nuclear Medicine, Department of Radiology, National Center for Global Health and Medicine

14 Department of Radiology, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology

15 Department of Pathology, Hidaka Hospital

16 Clinical Development Department, Nihon Medi-Physics Co., Ltd.


Objective(s): 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 contrastenhanced 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.


Main Subjects

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