Diagnostic Performance and Safety of Positron Emission Tomography Using (18)F-Fluciclovine in Patients with Clinically Suspected High- or Low-grade Gliomas: A Multicenter Phase IIb Trial

OBJECTIVE(S): The study objective was to assess the diagnostic performance of positron emission tomography (PET) for gliomas using the novel tracer (18)F-fluciclovine (anti-[(18)F]FACBC) and to evaluate the safety of this tracer in patients with clinically suspected gliomas. METHODS: Anti-[(18)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-[(18)F]FACBC PET imaging but not using contrast-enhanced T1-weighted imaging” or “areas visualized using both anti-[(18)F]FACBC-PET imaging and contrast-enhanced T1-weighted imaging” and were histopathologically examined to assess the diagnostic accuracy of anti-[(18)F]FACBC-PET for gliomas. RESULTS: The positive predictive value of anti-[(18)F]FACBC-PET imaging for glioma in areas visualized using anti-[(18)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-[(18)F]FACBC-PET imaging was 87.5% (7/8). Twelve adverse events occurred in 7 (17.5%) of the 40 patients who received anti-[(18)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-[(18)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.