Diagnostic Performance and Safety of Positron Emission Tomography Using 18FFluciclovine in Patients with Clinically Suspected High or Lowgrade 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 18Ffluciclovine (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 lowgrade gliomas, followed by PET imaging. T1weighted, contrastenhanced T1weighted, and fluidattenuated inversion recovery (or T2weighted) 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 contrastenhanced T1weighted imaging” or “areas visualized using both anti[18F]FACBCPET imaging and contrastenhanced T1weighted imaging” and were histopathologically examined to assess the diagnostic accuracy of anti[18F]FACBCPET for gliomas.Results: The positive predictive value of anti[18F]FACBCPET imaging for glioma in areas visualized using anti[18F]FACBCPET imaging, but not visualized using contrastenhanced T1 weighted images, was 100.0% (26/26), and the value in areas visualized using both contrastenhanced T1weighted imaging and anti [18F]FACBCPET 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]FACBCPET imaging was effective for the detection of gliomas in areas not visualized using contrastenhanced T1weighted MRI and the tracer was well tolerated.