Toshihiko Wakabayashi - Department of Neurosurgery, Nagoya University, Graduate School of Medicine
Toshihiko Iuchi - Division of Neurological Surgery, Chiba Cancer Center
Naohiro Tsuyuguchi - Department of Neurosurgery, Osaka City University Graduate School of Medicine
Ryo Nishikawa - Department of Neuro-Oncology/Neurosurgery, Saitama International Medical Center, Saitama Medical University

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.

Clinical trial, 18F-fluciclovine, Glioma, Positron Emission Tomography, brain tumor