1Department of Neurosurgery, Nagoya University, Graduate School of Medicine
2Division of Neurological Surgery, Chiba Cancer Center
3Department of Neurosurgery, Osaka City University Graduate School of Medicine
4Department of Neuro-Oncology/Neurosurgery, Saitama International Medical Center, Saitama Medical University
5Department of Neurosurgery, Kyoto University Graduate School of Medicine
6Department of Neurosurgery, Kobe University Graduate School of Medicine
7Department of Neurological Surgery, Faculty of Medicine, Kagawa University
8Department of Neurosurgery, Tokyo Medical and Dental University
9Department of Neurosurgery and Neuro-Oncology, National Cancer Center Hospital
10Department of Neurosurgery, Osaka University Graduate School of Medicine
11Department of Neurosurgery, Juntendo Tokyo Koto Geriatric Medical Center
12Integrative Brain Imaging Center, National Center of Neurology and Psychiatry
13Division of Nuclear Medicine, Department of Radiology, National Center for Global Health and Medicine
14Department of Radiology, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
15Department of Pathology, Hidaka Hospital
16Clinical 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.
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